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Peripheral neuropathy is a type of nerve damage that typically affects the feet and legs and sometimes affects the hands and arms.

This type of neuropathy is very common. Up to one-half of people with diabetes have peripheral neuropathy.1,2

Over time, high blood glucose, also called blood sugar, and high levels of fats, such as triglycerides, in the blood from diabetes can damage your nerves and the small blood vessels that nourish your nerves, leading to peripheral neuropathy.

If you have peripheral neuropathy, your feet, legs, hands, or arms may feel

You may feel extreme pain in your feet, legs, hands, and arms, even when they are touched lightly. You may also have problems sensing pain or temperature in these parts of your body.

Symptoms are often worse at night. Most of the time, you will have symptoms on both sides of your body. However, you may have symptoms only on one side.

If you have peripheral neuropathy, you might experience:

Peripheral neuropathy can cause foot problems that lead to blisters and sores. If peripheral neuropathy causes you to lose feeling in your feet, you may not notice pressure or injuries that lead to blisters and sores. Diabetes can make these wounds difficult to heal and increase the chance of infections. These sores and infections can lead to the loss of a toe, foot, or part of your leg. Finding and treating foot problems early can lower the chances that you will develop serious infections.

This type of diabetes-related nerve damage can also cause changes to the shape of your feet and toes. A rare condition that can occur in some people with diabetes is Charcots foot, a problem in which the bones and tissue in your foot are damaged.

Peripheral neuropathy can make you more likely to lose your balance and fall, which can increase your chance of fractures and other injuries. The chronic pain of peripheral neuropathy can also lead to grief, anxiety, and depression.

Doctors diagnose peripheral neuropathy based on your symptoms, family and medical history, a physical exam, and tests. A physical exam will include a neurological exam and a foot exam.

If you have diabetes, you should get a thorough exam to test how you feel in your feet and legs at least once a year. During this exam, your doctor will look at your feet for signs of problems and check the blood flow and feeling, or sensation, in your feet by

Your doctor may also check if you can feel temperature changes in your feet.

Your doctor may perform tests to rule out other causes of nerve damage, such as a blood test to check for thyroid problems, kidney disease, or low vitamin B12 levels. If low B12 levels are found, your doctor will do additional tests to determine the cause. Metformin use is among several causes of low vitamin B12 levels. If B12 deficiency is due to metformin, metformin can be continued with B12 supplementation.

You can prevent the problems caused by peripheral neuropathy by managing your diabetes, which means managing your blood glucose, blood pressure, and cholesterol. Staying close to your goal numbers can keep nerve damage from getting worse.

If you have diabetes, check your feet for problems every day and take good care of your feet. If you notice any foot problems, call or see your doctor right away.

Remove your socks and shoes in the exam room to remind your doctor to check your feet at every office visit. See your doctor for a foot exam at least once a yearmore often if you have foot problems. Your doctor may send you to a podiatrist.

Doctors may prescribe medicine and other treatments for pain.

Your doctor may prescribe medicines to help with pain, such as certain types of

Although these medicines can help with the pain, they do not change the nerve damage. Therefore, if there is no improvement with a medicine to treat pain, there is no benefit to continuing to take it and another medication may be tried.

All medicines have side effects. Ask your doctor about the side effects of any medicines you take. Doctors dont recommend some medicines for older adults or for people with other health problems, such as heart disease.

Some doctors recommend avoiding over-the-counter pain medicines, such as acetaminophen and ibuprofen. These medicines may not work well for treating most nerve pain and can have side effects.

Your doctor may recommend other treatments for pain, including

Diabetes experts have not made special recommendations about supplements for people with diabetes. For safety reasons, talk with your doctor before using supplements or any complementary or alternative medicines or medical practices.

[1] Pop-Busui R, Boulton AJ, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136154.

[2] Izenberg A, Perkins BA, Bril V. Diabetic neuropathies. Seminars in Neurology. 2015;35(4):424430.

Link:

Peripheral Neuropathy | NIDDK

Treatment for peripheral neuropathymay includetreating any underlying cause or any symptoms you're experiencing.

Treatment may be more successfulfor certain underlying causes.For example,ensuringdiabetesis well controlled may help improve neuropathy or at least stop it getting worse.

There are many different possible causes of peripheral neuropathy, some of which can be treated in different ways. For example:

Some less common types of peripheral neuropathy may be treated with medication, such as:

However, the underlying cause may not always be untreatable.

You may also require medication to treat any nerve pain (neuropathic pain)you're experiencing.

Unlike most other types of pain, neuropathic pain doesn't usually get better with common painkillers, such as paracetamol andibuprofenand other medications areoften used.

These should usually be started at the minimum dose, with the dose gradually increased until you notice an effect, becausethe ideal dose for each person is unpredictable. Higher doses may bebetter at managing the pain, but are also more likely to cause side effects.

The most common side effects are tiredness, dizziness or feeling "drunk". If you get these, it may be necessary to reduce your dose. Don't drive or operate machineryif you experience drowsiness or blurred vision. You also may become more sensitive to the effects of alcohol.

The side effects should improve after a week or two as your body gets used to the medication. However, if your side effects continue, tell your GPas it may be possible to change to a different medication that suits you better.

Even if the first medication tried doesn't help, others may.

Many of these medications may also be used for treating other conditions, such as depression, epilepsy, anxiety or headaches. If you're given an antidepressant, this may treat pain even if you're not depressed.This doesn't mean your doctor suspects you're depressed.

The main medications recommended for neuropathic pain include:

There are also some additional medications that can be used to relieve pain in a specific area of the body or to relieve particularly severe pain for short periods. These are described below.

If your pain is confined to a particular area of your body and you can't, or would prefer not to,take the medications above, you may benefit from using capsaicin cream.

Capsaicin is the substance that makes chilli peppers hot and is thought to work in neuropathic pain by stopping the nerves sending pain messages to the brain.

A pea-sized amount of capsaicin cream is rubbed on the painful area of skin three or four times a day.

Side effects of capsaicin cream can include skin irritation and a burning sensation in the treated area when you first start treatment.

Don't use capsaicin cream on broken or inflamed skin and always wash your hands after applying it.

This is a large sticking plaster that contains a local anaesthetic. It's useful when pain affects only a small area of skin. It's stuck over the area of painful skin and the local anaesthetic is absorbed into the skin that's covered.

Tramadol is a powerful painkiller related to morphine that can be used to treat neuropathic pain that doesn't respond to other treatments your GP can prescribe.

Like all opioids, tramadol can be addictive if it's taken for a long time. It will usually only be prescribed for a short time.Tramadol can be useful to take at times when your pain is worse.

Common side effects of tramadol include:

In addition to treating pain, you may also require treatment to help you manage other symptoms you're experiencing as a result of peripheral neuropathy.

For example, if you have muscle weakness, you may need physiotherapyto learn exercises to improve your muscle strength. You may also need to wear splints to support weak ankles or use walking aids to help you get around.

Other problems associated with peripheral neuropathymay be treatable with medication, such as:

In some cases, you may need more invasive treatment, such as botulinum toxin injections for hyperhidrosisor urinary catheterisation if you have problems emptying your bladder.

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Peripheral neuropathy - Illnesses & conditions | NHS inform

Polyneuropathy (poly- + neuro- + -pathy) is damage or disease affecting peripheral nerves (peripheral neuropathy) in roughly the same areas on both sides of the body, featuring weakness, numbness, and burning pain.[3] It usually begins in the hands and feet and may progress to the arms and legs and sometimes to other parts of the body where it may affect the autonomic nervous system. It may be acute or chronic. A number of different disorders may cause polyneuropathy, including diabetes and some types of GuillainBarr syndrome.[4][5][6]

Polyneuropathies may be classified in different ways, such as by cause,[1] by presentation,[3] or by classes of polyneuropathy, in terms of which part of the nerve cell is affected mainly: the axon, the myelin sheath, or the cell body.[7][8]

Among the signs/symptoms of polyneuropathy, which can be divided (into sensory and hereditary) and are consistent with the following:[3]

The causes of polyneuropathy can be divided into hereditary and acquired and are therefore as follows:[1]

In regards to the pathophysiology of polyneuropathy, of course, the former depends on which polyneuropathy. For instance in the case of chronic inflammatory demyelinating polyneuropathy, one finds that it is a autoimmune disease. Here, T cells involvement has been demonstrated, while in terms of demyelination, antibodies alone are not capable.[16]

The diagnosis of polyneuropathies begins with a history and physical examination to ascertain the pattern of the disease process (such as-arms, legs, distal, proximal) if they fluctuate, and what deficits and pain are involved. If pain is a factor, determining where and how long the pain has been present is important, one also needs to know what disorders are present within the family and what diseases the person may have. Although diseases often are suggested by the physical examination and history alone, tests that may be employed include: electrodiagnostic testing, serum protein electrophoresis, nerve conduction studies, urinalysis, serum creatine kinase (CK) and antibody testing (nerve biopsy is sometimes done).[3][2]

Other tests may be used, especially tests for specific disorders associated with polyneuropathies, quality measures have been developed to diagnose patients with distal symmetrical polyneuropathy (DSP).[17]

In terms of the differential diagnosis for polyneuropathy one must look at the following:

In the treatment of polyneuropathies one must ascertain and manage the cause, among management activities are: weight decrease, use of a walking aid, and occupational therapist assistance. Additionally BP control in those with diabetes is helpful, while intravenous immunoglobulin is used for multifocal motor neuropathy.[3]

According to Lopate, et al., methylprednisolone is a viable treatment for chronic inflammatory demyelinative polyneuropathy (which can also be treated with intravenous immunoglobulin). The authors also indicate that prednisone has greater adverse effects in such treatment, as opposed to intermittent (high-doses) of the aforementioned medication.[3][21]

According to Wu, et al., in critical illness polyneuropathy supportive and preventive therapy are important for the affected individual, as well as, avoiding (or limiting) corticosteroids.[22]

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Polyneuropathy - Wikipedia

What is ophthalmology?Ophthalmology is a branch of medicine which deals with the eyes and visual system, and diagnosing, treating, and preventing diseases and conditions affecting them.Ophthalmology is a mixed medical and surgical specialty, and deals with a diverse range of issues. Eye health services are very important, as eye problems, such as cataracts, are very common, affecting a large number of people across the UK, and as the population ages, the incidence of age-related macular degeneration (AMD) increases. If these diseases are caught early enough, they can be treated and managed with the expertise of ophthalmologists.What conditions does an ophthalmologist treat?Although the eye is a small organ, its importance cannot be overstated, and, due to the complexity of our visual mechanics, the eyes can be affected by a number of different problems and diseases. As such, ophthalmologists have to be trained to deal with a wide variety of visual problems. Some of these eye problems are very common for instance, cataract surgery is the second most common operation performed on the NHS in England.Some of the conditions ophthalmologists treat include:Which subspecialties are included under ophthalmology?Sub-specialty interests for ophthalmologists include:

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The best Ophthalmologists in 2019 | TopDoctors

If you are experiencing an eye emergency involving sudden vision loss or the acute onset of pain or double vision, call 911 or seek emergency care immediately. The UK Chandler Emergency Department has ophthalmology providers on call 24/7.

UK Advanced Eye Care provides expert eye care for all ages ranging from simple eye exams to diagnosing and treating the most complex eye diseases in a new state-of-the art facility.

Using the widest range and most up-to-date technology in the state, our fellowship-trained specialists are able to diagnose and treat various eye diseases and conditions including:

Having our entire team of optometrists, general ophthalmologists and specialists together in one location allows for improved efficiency, increased continuity of care, and ease of referrals for further testing, surgical consultation or treatment.

At UK Advanced Eye Care, we are proud of our patient care services. We are hiring full-time ophthalmic technicians and patient care coordinators. We offer competitive benefits and on-the-job training.

Contact Philip Moss if you are interested: 859-323-0729 or philip.moss@uky.edu.

Shriners Hospitals for Children Medical Center Lexington

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(Primary eye care and all subspecialty eye care)

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2195 Harrodsburg RoadFirst floorLexington, KY 40504

Monday - Friday: 8:00 am-5:00 pm

(Primary eye care)

PLEASE NOTE: UK Optical Shops at Shriners and Turfland are CLOSED. The providers of General Ophthalmology are still seeing patients as scheduled. See full notice

UK HealthCare Jessamine Eye Center

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(Primary eye care, retina and vitreous disorders)

UK HealthCare Eye Center - Richmond

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Advanced Eye Care | UK HealthCare

You've probably wondered how you developed diabetes. You may worry that your children will develop it too.

Unlike some traits, diabetes does not seem to be inherited in a simple pattern. Yet clearly, some people are born more likely to develop diabetes than others.

Type 1 andtype 2 diabeteshave different causes. Yet two factors are important in both. You inherit a predisposition to the disease, then something in your environment triggers it.

Genes alone are not enough. One proof of this is identical twins. Identical twins have identical genes. Yet when one twin hastype 1 diabetes, the other gets the disease at most only half the time. When one twin has type 2 diabetes, the other's risk is at most 3 in 4.

In most cases of type 1 diabetes, people need to inherit risk factors from both parents. We think these factors must be more common in whites because whites have the highest rate of type 1 diabetes.

Because most people who are at risk do not get diabetes, researchers want to find out what the environmental triggers are. One trigger might be related to cold weather. Type 1 diabetes develops more often in winter than summer and is more common in places with cold climates. Another trigger might be viruses. Perhaps a virus that has only mild effects on most people triggers type 1 diabetes in others.

Early diet may also play a role. Type 1 diabetes is less common in people who were breastfed and in those who first ate solid foods at laterages.

In many people, the development of type 1 diabetes seems to take many years. In experiments that followed relatives of people with type 1 diabetes, researchers found that most of those who later got diabetes had certain autoantibodies in their blood for years before. (Antibodies are proteins that destroy bacteria or viruses. Autoantibodies areantibodies'gone bad' that attack the body's own tissues.)

If you are a man with type 1 diabetes, the odds of your child developing diabetes are 1 in 17. If you are a woman with type 1 diabetes and your child was born before you were 25, your child's risk is 1 in 25; if your child was born after you turned 25, your child's risk is 1 in 100.

Your child's risk is doubled if you developed diabetes before age 11. If both you and your partner have type 1 diabetes, the risk is between 1 in 10 and 1 in 4.

There is an exception to these numbers. About 1 in every 7 people with type 1 diabetes has a condition called type 2 polyglandular autoimmune syndrome. In addition to having diabetes, these people also have thyroid disease and a poorly working adrenalgland. Some also have otherimmune systemdisorders. If you have this syndrome, your child's risk of getting the syndromeincluding type 1 diabetesis 1 in 2.

Researchers are learning how to predict a person's odds of getting diabetes. For example, most whites with type 1 diabetes have genes called HLA-DR3 or HLA-DR4. If you and your child are white and share these genes, your child's risk is higher. (Suspect genes in other ethnic groups are less well studied. The HLA-DR7 gene may put African Americans at risk, and the HLA-DR9 gene may put Japanese at risk.)

Other tests can also make your child's risk clearer. A special test that tells how the body responds toglucosecan tell which school-aged children are most at risk.

Another more expensive test can be done for children who have siblings with type 1 diabetes. This test measures antibodies toinsulin, to islet cells in thepancreas, or to anenzymecalled glutamic acid decarboxylase. High levels can indicate that a child has a higher risk of developing type 1 diabetes.

Type 2 diabetes has a stronger link to family history and lineage than type 1, and studies of twins have shown that genetics play a very strong role in the development of type 2 diabetes.

Yet it also depends on environmental factors.Lifestyle also influences the development of type 2 diabetes.Obesitytends to run in families, and families tend to have similar eating and exercise habits.

If you have a family history of type 2 diabetes, it may be difficult to figure out whether your diabetes is due to lifestyle factors or genetic susceptibility. Most likely it is due to both. However, dont lose heart. Studies show that it is possible to delay or prevent type 2 diabetes by exercising and losing weight.

Have you recently been diagnosed with type 2 diabetes?Join our free Living With Type 2 Diabetes program and get the information and support you need to live well with diabetes.

Type 2 diabetes runs in families. In part, this tendency is due to children learning bad habitseating a poor diet, not exercisingfrom their parents. But there is also a genetic basis.

If you would like to learn more about the genetics of all forms of diabetes, the National Institutes of Health has publishedThe Genetic Landscape of Diabetes. This free online book provides an overview of the current knowledge about the genetics of type 1 and type 2 diabetes, as well other less common forms of diabetes. The book is written for healthcare professionals and for people with diabetes interested in learning more about the disease.

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Genetics of Diabetes | ADA

Please save the date for oursecond Career Club of the fall semester!We are very excited to listen to Dr. Robyn Baldens talk about: Medical Science Liaison and other opportunities at Merck nextFriday,September 20th at12:00 PMinNMR/Rm. N127

Dr. Balden is a physician scientist and Regional Medical Scientific Director for Anesthesia/Surgery, South/Central US Medical Affairs division of Merck Research Labs. This role integrates internal and external scientific exchange and collaboration in order to facilitate and support clinical and drug development programs and maximize patient safety and outcomes related to existing pharmaceuticals including clinical trials, investigator-initiated studies, medical education, and scientific content creation.Her role at Merck began in 2018 as Associate Director, Medical Science Liaison for Anesthesia/Surgery, South/Central US, subsequent to gaining experience conducting medical research and directing business development for clinical trials at the Texas Center for Drug Development in Houston, TX. At the Texas Center for Drug Development she engaged in medical affairs focusing on coordination of clinical research for various therapeutic areas, serving as a supporting investigator for clinical trials, scientific discussion and account management with key physician leaders, and development of medical educational materials. Prior to this role she was a surgical intern, resident anesthesiologist, and clinical scholar at Cedars-Sinai Medical Center in Los Angeles, CA, where she initiated clinical studies for novel anesthetic regimens.

Dr. Balden received her MD and PhD in Neuroscience from Texas A&M Health Science Center College of Medicine. Her passions involve the intersection of medicine and science with neuroimmunology and neuroendocrinology. She also collaborates with advocacy and student organizations, has written several academic papers on Vitamin D, and served as a member of the Vitamin D Councils Board of Directors contributing as a volunteer writer, podcast contributor, and graphic designer for the Vitamin D Council. Shelives with her family in Houston, TX and enjoys painting, design, traveling, scuba diving, outdoors, live music, reading, cooking, and gardening.

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Ph.D. in Genetics at Texas A&M University

By Linda Cole

Modern day veterinarians have an essential role in the health and welfare of our pets, as well as livestock and wildlife. Vets are well-versed in the science of animal health, and they promote public health by identifying and combating infectious zoonotic diseases that can be passed from animals to humans. Advances in medical science have provided veterinary professionals with sophisticated equipment, tests, procedures and medicines to treat our pets. However, the history of veterinary science dates back much further than you may realize.

The first known people to dabble in the field of veterinary medicine began around 9000 BC in Middle East countries including Saudi Arabia, Egypt, Iran, Turkey and Iraq. Sheepherders had a crude understanding of medical skills which were used to treat their dogs and other animals. From 4000 to 3000 BC, Egyptians took earlier medical skills and made further advancements. Historical records and Egyptian hieroglyphs record how they used herbs to treat and promote good health in domesticated animals.

Vedic literature, which was written around 1500 BC, refers to four sacred texts from India written in the Sanskrit language that forms the basis of the Hindu religion. The Kahun Papyrus from Egypt dates back to 1900 BC. Both texts are likely the first written accounts of veterinary medicine. One of the sacred texts documents Indias first Buddhist king, Asoka, who ensured there were two kinds of medicine: one for humans and one for animals. If he discovered there was no medicine available for one or the other, he ordered healing herbs to be bought and planted where they were needed.

The Kahun Papyrus is the oldest known papyrus medical text. Its divided into 34 sections that deal with specific topics. One of the topics is animal gynecology. Tomb drawings predating the Kahun Papyrus by a couple thousand years document early Egyptian understanding of gynecology. Trained specialists were skilled obstetricians and given the name of overseer of cattle. They were charged with examining cattle, attending to pregnancies, and the birthing of calves to ensure their health and survival.

Archaeologists found fragments of a papyrus that was a medical textbook from somewhere around 1850 BC, indicating that Egyptians were familiar with the anatomy of animals, could recognize early warning signs of certain diseases in dogs, birds, fish and cattle, and used specific treatments to deal with them. The Romans, Greeks, Babylonians, Hindus, Arabs and Hebrews also practiced animal medicine. A man named Urlugaledinna, who lived in Mesopotamia in 3000 BC, was considered an expert in his ability to heal animals. Around 500 BC, a Greek scientist named Alcmaeon dissected animals to study them.

Early attempts to regulate and organize the treatment of animals were mainly focused on horses because of their economic importance to society. During the Middle Ages, farriers combined their trade of horseshoeing with general horse doctoring. When the Lord Mayor of London, which is different from the Mayor of London, learned about the poor care horses in London were receiving in 1356, he persuaded all farriers within a seven mile radius of the city to form a fellowship to improve and regulate how they treated horses. The fellowship led to the creation in 1674 of the Worshipful Company of Farriers.

The first veterinary school was founded in Lyon, France in 1761 by Claude Bourgelat, and thats when the profession of veterinary medicine officially began. The school focused on studying the anatomy and diseases of sheep, horses and cattle in an effort to combat cattle deaths from a plague in France. Cattle plagues were common throughout history, but attempts to learn how to fight microorganisms had to wait until the invention of the microscope sometime in the 1590s. The first vaccinations for cattle were developed in 1712 and used to eradicate a plague in Europe.

Over the next ten years, veterinary schools were established in Germany, Sweden and Denmark. In 1791, the London Veterinary College was established and developed veterinary science at a professional level dedicated to animal medicine. The wellbeing and health of horses was their initial focus for years, because of the use of horses in the Army. Eventually they turned their attention to cattle and other livestock, and finally added dogs and other animals.

The first veterinary school established in the United States was the Veterinary College of Philadelphia in 1852, which operated until 1866. In 1883, the School of Veterinary Medicine at the University of Pennsylvania was established and is the oldest accredited veterinary school still in operation. The American Veterinary Medical Association (AVMA) was established in 1863, and the Bureau of Animal Industry under the USDA was set up in 1884 and in operation until 1900. Its purpose was to protect the public from infectious diseases through contaminated meat, eradicate diseases in animals and improve the quality of livestock.

Top photo by Bainbridge Bethesda/FlickrBottom photo by Anne Worner/Flickr

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A Quick History of Veterinary Medicine | CANIDAE

Have you been told that steroid injections or invasive surgery are your only options to treat your knee pain? Interventional orthopedics provides a non-surgical alternative that uses your own cells to repair the damage.

Recent researchshows that some of the most popularorthopedic kneesurgeriesincluding meniscectomies have no benefit and are not more effective than placebo or sham surgery. Moreover, knee replacement is extremely traumatic and carries associated risks, and even successful surgeries minimally require months of painful rehab to regain strength and mobility. Most surgeries also accelerate degeneration that leads toosteoarthritis and exacerbate the biomechanical problems that initially led to the need for the surgery. Regenexx urges patients suffering from knee injuries or degenerative conditions to consider all of their options.

At Regenexx we inventeda new approachto orthopedic care we call Interventional Orthopedics. This approach involves the use ofimage guidance (flouroscopy and ultrasound) to precisely placehigh-dose stem cells or platelets from your body directly where they are needed in a specific joint structure. These cells then work in the site of your injury to grow into new, healthy tissue, a process that will only occur if the cells have been placed exactly where they need to go in order to achieve positive outcomes for the patient.This precise approach to orthopedic care cant be replicated by a surgeon or nurse in a chiropractors office. Interventional Orthopedics requiresthousands of hours of trainingfollowing a standardized protocol process to become a licensed Regenexx physician.

The innovative Regenexx procedures restore knee function and mobility and decrease pain without the need for surgery by regenerating damaged tissue. Duringthis outpatient procedure, ourexpert physiciansuseprecise image guidanceto injectcustom concentrationsofyour bodys natural healing agentsinto the exact areas of damage to tighten and stabilize your knee joint for better function and mobility.

This page contains an extensive library of educational resources on kneeconditions and our patented kneeprocedures created by Regenexx and our founder, Chris Centeno, M.D.. We encourage you to research your options.

GET RELIEF. 855-330-5818

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Stem Cell Therapy For Knees | Relief Without Surgery!

This is a whole new era where were moving beyond little edits on single genes to being able to write whatever we want throughout the genome.

-George Church, Professor of Genetics at Harvard Medical School

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How are scientists putting natures machinery to use for the good of humanity, and how could things go wrong?

Biotechnology is nearly as old as humanity itself. The food you eat and the pets you love? You can thank our distant ancestors for kickstarting the agricultural revolution, using artificial selection for crops, livestock, and other domesticated animals. When Edward Jenner invented vaccines and when Alexander Fleming discovered antibiotics, they were harnessing the power of biotechnology. And, of course, modern civilization would hardly be imaginable without the fermentation processes that gave us beer, wine, and cheese!

When he coined the term in 1919, the agriculturalist Karl Ereky described biotechnology as all lines of work by which products are produced from raw materials with the aid of living things. In modern biotechnology, researchers modify DNA and proteins to shape the capabilities of living cells, plants, and animals into something useful for humans. Biotechnologists do this by sequencing, or reading, the DNA found in nature, and then manipulating it in a test tube or, more recently, inside of living cells.

In fact, the most exciting biotechnology advances of recent times are occurring at the microscopic level (and smaller!) within the membranes of cells. After decades of basic research into decoding the chemical and genetic makeup of cells, biologists in the mid-20th century launched what would become a multi-decade flurry of research and breakthroughs. Their work has brought us the powerful cellular tools at biotechnologists disposal today. In the coming decades, scientists will use the tools of biotechnology to manipulate cells with increasing control, from precision editing of DNA to synthesizing entire genomes from their basic chemical building blocks. These cells could go on to become bomb-sniffing plants, miracle cancer drugs, or de-extincted wooly mammoths. And biotechnology may be a crucial ally in the fight against climate change.

But rewriting the blueprints of life carries an enormous risk. To begin with, the same technology being used to extend our lives could instead be used to end them. While researchers might see the engineering of a supercharged flu virus as a perfectly reasonable way to better understand and thus fight the flu, the public might see the drawbacks as equally obvious: the virus could escape, or someone could weaponize the research. And the advanced genetic tools that some are considering for mosquito control could have unforeseen effects, possibly leading to environmental damage. The most sophisticated biotechnology may be no match for Murphys Law.

While the risks of biotechnology have been fretted over for decades, the increasing pace of progress from low cost DNA sequencing to rapid gene synthesis to precision genome editing suggests biotechnology is entering a new realm of maturity regarding both beneficial applications and more worrisome risks. Adding to concerns, DIY scientists are increasingly taking biotech tools outside of the lab. For now, many of the benefits of biotechnology are concrete while many of the risks remain hypotheticals, but it is better to be proactive and cognizant of the risks than to wait for something to go wrong first and then attempt to address the damage.

Satellite images make clear the massive changes that mankind has made to the surface of the Earth: cleared forests, massive dams and reservoirs, millions of miles of roads. If we could take satellite-type images of the microscopic world, the impact of biotechnology would be no less obvious. The majority of the food we eat comes from engineered plants, which are modified either via modern technology or by more traditional artificial selection to grow without pesticides, to require fewer nutrients, or to withstand the rapidly changing climate. Manufacturers have substituted petroleum-based ingredients with biomaterials in many consumer goods, such as plastics, cosmetics, and fuels. Your laundry detergent? It almost certainly contains biotechnology. So do nearly all of your cotton clothes.

But perhaps the biggest application of biotechnology is in human health. Biotechnology is present in our lives before were even born, from fertility assistance to prenatal screening to the home pregnancy test. It follows us through childhood, with immunizations and antibiotics, both of which have drastically improved life expectancy. Biotechnology is behind blockbuster drugs for treating cancer and heart disease, and its being deployed in cutting-edge research to cure Alzheimers and reverse aging. The scientists behind the technology called CRISPR/Cas9 believe it may be the key to safely editing DNA for curing genetic disease. And one company is betting that organ transplant waiting lists can be eliminated by growing human organs in chimeric pigs.

Along with excitement, the rapid progress of research has also raised questions about the consequences of biotechnology advances. Biotechnology may carry more risk than other scientific fields: microbes are tiny and difficult to detect, but the dangers are potentially vast. Further, engineered cells could divide on their own and spread in the wild, with the possibility of far-reaching consequences. Biotechnology could most likely prove harmful either through the unintended consequences of benevolent research or from the purposeful manipulation of biology to cause harm. One could also imagine messy controversies, in which one group engages in an application for biotechnology that others consider dangerous or unethical.

Sugarcane farmers in Australia in the 1930s had a problem: cane beetles were destroying their crop. So, they reasoned that importing a natural predator, the cane toad, could be a natural form of pest control. What could go wrong? Well, the toads became a major nuisance themselves, spreading across the continent and eating the local fauna (except for, ironically, the cane beetle).

While modern biotechnology solutions to societys problems seem much more sophisticated than airdropping amphibians into Australia, this story should serve as a cautionary tale. To avoid blundering into disaster, the errors of the past should be acknowledged.

The world recently witnessed the devastating effects of disease outbreaks, in the form of Ebola and the Zika virus but those were natural in origin. The malicious use of biotechnology could mean that future outbreaks are started on purpose. Whether the perpetrator is a state actor or a terrorist group, the development and release of a bioweapon, such as a poison or infectious disease, would be hard to detect and even harder to stop. Unlike a bullet or a bomb, deadly cells could continue to spread long after being deployed. The US government takes this threat very seriously, and the threat of bioweapons to the environment should not be taken lightly either.

Developed nations, and even impoverished ones, have the resources and know-how to produce bioweapons. For example, North Korea is rumored to have assembled an arsenal containing anthrax, botulism, hemorrhagic fever, plague, smallpox, typhoid, and yellow fever, ready in case of attack. Its not unreasonable to assume that terrorists or other groups are trying to get their hands on bioweapons as well. Indeed, numerous instances of chemical or biological weapon use have been recorded, including the anthrax scare shortly after 9/11, which left 5 dead after the toxic cells were sent through the mail. And new gene editing technologies are increasing the odds that a hypothetical bioweapon targeted at a certain ethnicity, or even a single individual like a world leader, could one day become a reality.

While attacks using traditional weapons may require much less expertise, the dangers of bioweapons should not be ignored. It might seem impossible to make bioweapons without plenty of expensive materials and scientific knowledge, but recent advances in biotechnology may make it even easier for bioweapons to be produced outside of a specialized research lab. The cost to chemically manufacture strands of DNA is falling rapidly, meaning it may one day be affordable to print deadly proteins or cells at home. And the openness of science publishing, which has been crucial to our rapid research advances, also means that anyone can freely Google the chemical details of deadly neurotoxins. In fact, the most controversial aspect of the supercharged influenza case was not that the experiments had been carried out, but that the researchers wanted to openly share the details.

On a more hopeful note, scientific advances may allow researchers to find solutions to biotechnology threats as quickly as they arise. Recombinant DNA and biotechnology tools have enabled the rapid invention of new vaccines which could protect against new outbreaks, natural or man-made. For example, less than 5 months after the World Health Organization declared Zika virus a public health emergency, researchers got approval to enroll patients in trials for a DNA vaccine.

Biotechnology doesnt have to be deadly, or even dangerous, to fundamentally change our lives. While humans have been altering genes of plants and animals for millennia first through selective breeding and more recently with molecular tools and chimeras we are only just beginning to make changes to our own genomes (amid great controversy).

Cutting-edge tools like CRISPR/Cas9 and DNA synthesis raise important ethical questions that are increasingly urgent to answer. Some question whether altering human genes means playing God, and if so, whether we should do that at all. For instance, if gene therapy in humans is acceptable to cure disease, where do you draw the line? Among disease-associated gene mutations, some come with virtual certainty of premature death, while others put you at higher risk for something like Alzheimers, but dont guarantee youll get the disease. Many others lie somewhere in between. How do we determine a hard limit for which gene surgery to undertake, and under what circumstances, especially given that the surgery itself comes with the risk of causing genetic damage? Scholars and policymakers have wrestled with these questions for many years, and there is some guidance in documents such as the United Nations Universal Declaration on the Human Genome and Human Rights.

And what about ways that biotechnology may contribute to inequality in society? Early work in gene surgery will no doubt be expensive for example, Novartis plans to charge $475,000 for a one-time treatment of their recently approved cancer therapy, a drug which, in trials, has rescued patients facing certain death. Will todays income inequality, combined with biotechnology tools and talk of designer babies, lead to tomorrows permanent underclass of people who couldnt afford genetic enhancement?

Advances in biotechnology are escalating the debate, from questions about altering life to creating it from scratch. For example, a recently announced initiative called GP-Write has the goal of synthesizing an entire human genome from chemical building blocks within the next 10 years. The project organizers have many applications in mind, from bringing back wooly mammoths to growing human organs in pigs. But, as critics pointed out, the technology could make it possible to produce children with no biological parents, or to recreate the genome of another human, like making cellular replicas of Einstein. To create a human genome from scratch would be an enormous moral gesture, write two bioethicists regarding the GP-Write project. In response, the organizers of GP-Write insist that they welcome a vigorous ethical debate, and have no intention of turning synthetic cells into living humans. But this doesnt guarantee that rapidly advancing technology wont be applied in the future in ways we cant yet predict.

Its nearly impossible to imagine modern biotechnology without DNA sequencing. Since virtually all of biology centers around the instructions contained in DNA, biotechnologists who hope to modify the properties of cells, plants, and animals must speak the same molecular language. DNA is made up of four building blocks, or bases, and DNA sequencing is the process of determining the order of those bases in a strand of DNA. Since the publication of the complete human genome in 2003, the cost of DNA sequencing has dropped dramatically, making it a simple and widespread research tool.

Benefits: Sonia Vallabh had just graduated from law school when her mother died from a rare and fatal genetic disease. DNA sequencing showed that Sonia carried the fatal mutation as well. But far from resigning to her fate, Sonia and her husband Eric decided to fight back, and today they are graduate students at Harvard, racing to find a cure. DNA sequencing has also allowed Sonia to become pregnant, since doctors could test her eggs for ones that dont have the mutation. While most peoples genetic blueprints dont contain deadly mysteries, our health is increasingly supported by the medical breakthroughs that DNA sequencing has enabled. For example, researchers were able to track the 2014 Ebola epidemic in real time using DNA sequencing. And pharmaceutical companies are designing new anti-cancer drugs targeted to people with a specific DNA mutation. Entire new fields, such as personalized medicine, owe their existence to DNA sequencing technology.

Risks: Simply reading DNA is not harmful, but it is foundational for all of modern biotechnology. As the saying goes, knowledge is power, and the misuse of DNA information could have dire consequences. While DNA sequencing alone cannot make bioweapons, its hard to imagine waging biological warfare without being able to analyze the genes of infectious or deadly cells or viruses. And although ones own DNA information has traditionally been considered personal and private, containing information about your ancestors, family, and medical conditions, governments and corporations increasingly include a persons DNA signature in the information they collect. Some warn that such databases could be used to track people or discriminate on the basis of private medical records a dystopian vision of the future familiar to anyone whos seen the movie GATTACA. Even supplying patients with their own genetic information has come under scrutiny, if its done without proper context, as evidenced by the dispute between the FDA and the direct-to-consumer genetic testing service 23andMe. Finally, DNA testing opens the door to sticky ethical questions, such as whether to carry to term a pregnancy after the fetus is found to have a genetic mutation.

The modern field of biotechnology was born when scientists first manipulated or recombined DNA in a test tube, and today almost all aspects of society are impacted by so-called rDNA. Recombinant DNA tools allow researchers to choose a protein they think may be important for health or industry, and then remove that protein from its original context. Once removed, the protein can be studied in a species thats simple to manipulate, such as E. coli bacteria. This lets researchers reproduce it in vast quantities, engineer it for improved properties, and/or transplant it into a new species. Modern biomedical research, many best-selling drugs, most of the clothes you wear, and many of the foods you eat rely on rDNA biotechnology.

Benefits: Simply put, our world has been reshaped by rDNA. Modern medical advances are unimaginable without the ability to study cells and proteins with rDNA and the tools used to make it, such as PCR, which helps researchers copy and paste DNA in a test tube. An increasing number of vaccines and drugs are the direct products of rDNA. For example, nearly all insulin used in treating diabetes today is produced recombinantly. Additionally, cheese lovers may be interested to know that rDNA provides ingredients for a majority of hard cheeses produced in the West. Many important crops have been genetically modified to produce higher yields, withstand environmental stress, or grow without pesticides. Facing the unprecedented threats of climate change, many researchers believe rDNA and GMOs will be crucial in humanitys efforts to adapt to rapid environmental changes.

Risks: The inventors of rDNA themselves warned the public and their colleagues about the dangers of this technology. For example, they feared that rDNA derived from drug-resistant bacteria could escape from the lab, threatening the public with infectious superbugs. And recombinant viruses, useful for introducing genes into cells in a petri dish, might instead infect the human researchers. Some of the initial fears were allayed when scientists realized that genetic modification is much trickier than initially thought, and once the realistic threats were identified like recombinant viruses or the handling of deadly toxins safety and regulatory measures were put in place. Still, there are concerns that rogue scientists or bioterrorists could produce weapons with rDNA. For instance, it took researchers just 3 years to make poliovirus from scratch in 2006, and today the same could be accomplished in a matter of weeks. Recent flu epidemics have killed over 200,000, and the malicious release of an engineered virus could be much deadlier especially if preventative measures, such as vaccine stockpiles, are not in place.

Synthesizing DNA has the advantage of offering total researcher control over the final product. With many of the mysteries of DNA still unsolved, some scientists believe the only way to truly understand the genome is to make one from its basic building blocks. Building DNA from scratch has traditionally been too expensive and inefficient to be very practical, but in 2010, researchers did just that, completely synthesizing the genome of a bacteria and injecting it into a living cell. Since then, scientists have made bigger and bigger genomes, and recently, the GP-Write project launched with the intention of tackling perhaps the ultimate goal: chemically fabricating an entire human genome. Meeting this goal and within a 10 year timeline will require new technology and an explosion in manufacturing capacity. But the projects success could signal the impact of synthetic DNA on the future of biotechnology.

Benefits: Plummeting costs and technical advances have made the goal of total genome synthesis seem much more immediate. Scientists hope these advances, and the insights they enable, will ultimately make it easier to make custom cells to serve as medicines or even bomb-sniffing plants. Fantastical applications of DNA synthesis include human cells that are immune to all viruses or DNA-based data storage. Prof. George Church of Harvard has proposed using DNA synthesis technology to de-extinct the passenger pigeon, wooly mammoth, or even Neanderthals. One company hopes to edit pig cells using DNA synthesis technology so that their organs can be transplanted into humans. And DNA is an efficient option for storing data, as researchers recently demonstrated when they stored a movie file in the genome of a cell.

Risks: DNA synthesis has sparked significant controversy and ethical concerns. For example, when the GP-Write project was announced, some criticized the organizers for the troubling possibilities that synthesizing genomes could evoke, likening it to playing God. Would it be ethical, for instance, to synthesize Einsteins genome and transplant it into cells? The technology to do so does not yet exist, and GP-Write leaders have backed away from making human genomes in living cells, but some are still demanding that the ethical debate happen well in advance of the technologys arrival. Additionally, cheap DNA synthesis could one day democratize the ability to make bioweapons or other nuisances, as one virologist demonstrated when he made the horsepox virus (related to the virus that causes smallpox) with DNA he ordered over the Internet. (It should be noted, however, that the other ingredients needed to make the horsepox virus are specialized equipment and deep technical expertise.)

Many diseases have a basis in our DNA, and until recently, doctors had very few tools to address the root causes. That appears to have changed with the recent discovery of a DNA editing system called CRISPR/Cas9. (A note on terminology CRISPR is a bacterial immune system, while Cas9 is one protein component of that system, but both terms are often used to refer to the protein.) It operates in cells like a DNA scissor, opening slots in the genome where scientists can insert their own sequence. While the capability of cutting DNA wasnt unprecedented, Cas9 dusts the competition with its effectiveness and ease of use. Even though its a biotech newcomer, much of the scientific community has already caught CRISPR-fever, and biotech companies are racing to turn genome editing tools into the next blockbuster pharmaceutical.

Benefits: Genome editing may be the key to solving currently intractable genetic diseases such as cystic fibrosis, which is caused by a single genetic defect. If Cas9 can somehow be inserted into a patients cells, it could fix the mutations that cause such diseases, offering a permanent cure. Even diseases caused by many mutations, like cancer, or caused by a virus, like HIV/AIDS, could be treated using genome editing. Just recently, an FDA panel recommended a gene therapy for cancer, which showed dramatic responses for patients who had exhausted every other treatment. Genome editing tools are also used to make lab models of diseases, cells that store memories, and tools that can detect epidemic viruses like Zika or Ebola. And as described above, if a gene drive, which uses Cas9, is deployed effectively, we could eliminate diseases such as malaria, which kills nearly half a million people each year.

Risks: Cas9 has generated nearly as much controversy as it has excitement, because genome editing carries both safety issues and ethical risks. Cutting and repairing a cells DNA is not risk-free, and errors in the process could make a disease worse, not better. Genome editing in reproductive cells, such as sperm or eggs, could result in heritable genetic changes, meaning dangerous mutations could be passed down to future generations. And some warn of unethical uses of genome editing, fearing a rise of designer babies if parents are allowed to choose their childrens traits, even though there are currently no straightforward links between ones genes and their intelligence, appearance, etc. Similarly, a gene drive, despite possibly minimizing the spread of certain diseases, has the potential to create great harm since it is intended to kill or modify an entire species. A successful gene drive could have unintended ecological impacts, be used with malicious intent, or mutate in unexpected ways. Finally, while the capability doesnt currently exist, its not out of the realm of possibility that a rogue agent could develop genetically selective bioweapons to target individuals or populations with certain genetic traits.

Videos

Research Papers

Books

Informational Documents

Articles

Organizations

The organizations above all work on biotechnology issues, though many cover other topics as well. This list is undoubtedly incomplete; please contact us to suggest additions or corrections.

Special thanks to Jeff Bessen for his help researching and writing this page.

Excerpt from:
Benefits & Risks of Biotechnology - Future of Life Institute

The Graduate School has just published a piece by MGM student, Nicole Stantial, and her teammates from the Emerging Leaders Institute on the project they executed to help graduate students and postdocs better understand U.S. health insurance. You can find the piece here: https://gradschool.duke.edu/professional-development/blog/understanding-duke-health-insurance-emerging-leaders-institute-project

Yadav receives Young Scientist Award. Vikas Yadav, a Postdoc in Joe Heitmans lab, receives Young Scientist awards from two science academies National Academy of Science, India (NASI) and Indian National Science Academy (INSA). The awards (INSA Medal for Young Scientist and NASI-Young Scientist Platinum Jubilee) are being given for his research work during his PhD with Prof. Kaustuv Sanyal at JNCASR, Bengaluru, India in a collaboration with the Heitman lab. The awards are considered to be the highest recognition of promise, creativity and excellence in a young Scientist. He characterized centromeres in the human fungal pathogen, Cryptococcus neoformans and identified the role of RNAi machinery in the regulation of centromeres length and structure. This work along with his other contributions was published in PNAS, PLoS biology, mBio and mSphere. Please click here to read more on this accomplishment.

Hoye Awarded a F32 from NINDS. Mariah Hoye, a postdoc in Debby Silvers lab, was recently awarded a F32 from NINDS for her work on a new intellectual disability gene, DDX3X, which codes for an RNA helicase. Previous work in the lab found that depletion of Ddx3x during embryonic brain development led to more neural progenitors and less neurons in mice. Dr. Hoye is now using a conditional knockout mouse to better understand the unique requirements for Ddx3x in neural progenitors and neurons during brain development. Specifically, Dr. Hoye is interested in understanding how DDX3X controls neural progenitor fate decisions, as loss of Ddx3x impairs neurogenesis. As an RNA helicase, DDX3X functions in multiple aspects of RNA processing, but has a prominent role in translation initiation of mRNAs with highly structured 5 UTRs. Dr. Hoye is employing a genome-wide translational analysis, ribosome footprinting, to identify mRNAs in neural progenitors which require DDX3X for their translation. Identifying these DDX3X-dependent mRNAs may inform mRNAs whose translation is required for neural progenitor fate decisions

Congratulations to Giny Fouda (secondary MGM Faculty) and Eleanor Semmes and Stephen Kirchner who are both MD/PhD students in MGM who were elected to the Duke University School of Medicine chapter of the Alpha Omega Alpha Medical Honor Society for the fall 2019. Twice a year the Alpha Omega Alpha (AOA) Medical Honor Society elects a small number of new members. The criteria include scholastic achievement, leadership capabilities, ethical standards, fairness in dealing with colleagues, demonstrated professionalism, achievement and/or potential for achievement in medicine, and a record of service to the school and community at large. Membership in AOA is a distinction that accompanies a physician throughout his or her career. In the fall the society elects a small number of faculty and alumni. The competition is especially stiff for faculty as only 3 are elected each year.

Celebration for Jinks-Robertson. The Department of Molecular Genetics and Microbiology held a special celebration to honor Sue Jinks-Robertson, PhD, Professor and co-Vice Chair in the department, on being elected to the National Academy of Sciences.

please click here for more photos

Congratulations Jackie Lin.Please congratulate Jackie Lin on her acceptance to medical school at the University of California San Francisco. Jackie was an undergraduate researcher in the Heitman lab.

Passing of Dr. Wolfgang Bill Joklik. It is with great sadness to inform you that Dr. Wolfgang Bill Joklik, Virologists and James B. Duke Professor Emeritus of Molecular Genetics and Microbiology, died in Durham, North Carolina on July 7, 2019. He chaired the department for 25 years.

In 1981 Dr. Joklik founded the American Society for Viriology, the first scientific society specifically for virologists, and served a two-year term as its founding president.

Trained as a biochemist, Dr. Joklik was one of the pioneers of Molecular Virology. His work on the mechanisms underlying how viruses infect cells, multiply and cause disease laid the groundwork for the development of vaccines and antiviral agents. He published more than 250 research papers and reviews, and for 25 years was Editor-in-Chief of and a major contributor to Zinsser Microbiology, one of the two leading texts for medical students. He was Editor-in-Chief of Virology, the primary journal in its field, for eighteen years. He was a member/chairman of numerous Study Sections and Committees of the National Institutes of health and the American Cancer Society.

The Joklik Distinguished Lectureship, founded in MGM in 2010 is held annually to honor Dr. Joklik. The tenth annual Joklik lecturer this year will be Tom Shenk from Princeton. His talk will be presented at the annual MGM Departmental Retreat, September 6-8, 2019 in Wrightsville Beach, NC.

Please join in extending your deepest condolences to Dr. Jokliks entire family and community of friends.

A mass of Christian burial for Dr. Joklik will be offered on Friday, July 12, 2019 at 10:00am at Immaculate Conception Catholic Church in Durham, NC.

To read the entire obituary, please click here .

The flags on Duke Universitys campus have been lowered to half staff in honor of Dr. Joklik.

Dr. Jokliks Lifetime Achievement Award Video (produced in 2013)

Kutsch receives German Research Foundation (DFG) fellowship. Congratulations to Miriam Kutsch, postdoc in the Coers lab, on being awarded this fellowship. The 2-year DFG research fellowship is intended to support German early career scientists conducting innovative research at an international institution. Miriams research aims to understand an immune defense program directed at bacteria entering the host cell cytosol of human cells. In her research, she applies innovative biochemical and cell biological approaches to determine how the human defense protein GBP1 catches and conquers bacterial invaders.

Sullivan named Associate Dean for Research Training. Beth Sullivan, PhD, Associate Professor of Molecular Genetics and Microbiology has been named Associate Dean for Research Training for the Duke School of Medicine. Dr. Sullivan, a human geneticist whose lab studies mechanisms of genome stability and centromere function, will oversee the Office of Biomedical Graduate Education and coordinate activities with the Office for Postdoctoral Affairs. She will provide leadership and broad strategic vision for all areas related to research training for biomedical Ph.D. students and postdoctoral appointees. Learn more at the Duke Med School blog: click here.

JNCASR has been featured in the top 10 list of Nature Index normalized ranking. Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) (www.jncasr.ac.in)is a multidisciplinary research institute situated in Bangalore, India. It is relatively young yet well-known around the world. The mandate of JNCASR is to pursue and promote world-class research and training at the frontiers of Science and Engineering covering broad areas ranging from Materials to Genetics. It provides a vibrant academic ambience hosting more than 300 researchers and around 50 faculty members. The Centre is funded by the Department of Science and Technology, Government of India and is a deemed university. JNCASR has been featured in the top 10 among the academic instituions in a recently published Nature Ranking (normalized) 2018 (https://www.nature.com/articles/d41586-019-01924-x). Kaustuv Sanyals group (www.jncasr.ac.in/sanyal) at JNCASR collaborates extensively with Joe Heitmans group in the Duke University Medical Center. This collaboration led to many discoveries and publications including a recent paper in PNAS that has been cosidered for JNCASRs recent ranking.

Heitman and Heaton receive ASM Award at the 2019 ASM Microbe Meeting. Joseph Heitman, M.D., Ph.D., James B. Duke Professor and Chair of the Department of Molecular Genetics and Microbiology and Nicholas Heaton, Ph.D., Assistant Professor in the Department of Molecular Genetics and Microbiology, received the 2019 ASM Microbe Award at the 2019 ASM Microbe conference in San Francisco, CA (June 20-25, 2019). ASM Microbe tweeted the awards here.

Congratulations Daniel Snellings.MGM graduate student Dan Snellings won first prize for best Oral Presentation in the Basic Sciences Category at the International Scientific Conference on Hereditary Hemorrhagic Telangiectasia, held in Rio Grande, Puerto Rico last week. This conference, held every two years, brings together physicians and scientists from around the world who are studying this hereditary vascular disease. Dans presentation showcased his discovery that the vascular malformations in HHT contain bi-allelic (germline plus somatic) mutations in the causative genes. His work overturns a long-standing but incorrect assumption that HHT is caused by haploinsufficiency of the gene product.

Martinez featured on Duke Health News for a recent study published in Cell. David Martinez, PhD, Postdoctoral Associate in the Department of Molecular Genetics and Microbiology along with Dr. Sallie Permar conducted research focusing on improving maternal vaccines that also protect newborns. To read more about the research, click here. To read the full manuscript, click here.

To read more, click here.

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MGM genetics, mycology, virology, bacteriology, graduate ...

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Category:Genetic engineering - Wikimedia Commons

RSS allows you to receive information and updates from a Web site. This page explains how to set up RSS feeds that will notify you of new study information on ClinicalTrials.gov. Subscribing to an RSS feed saves you time because you will not have to check each study record in your search results for updates.

RSS feeds can provide updates to the results of a specific search, on all recently addedstudy records,or on all recently modified studies. The RSS feed will automatically list additions and updates to your search results in either your Internet browser or a feed reader (see How to Subscribe to a Feed).

Creating an RSS feed for a specific search allows you to easily access and browse study records meeting your search criteria that have been first posted or last update posted in the last 14 days. To create the feed from the Search Results page, follow the instructions provided in the example below.

To practice creating an RSS feed for a targeted search for recruiting studies about the condition Huntington Disease, follow these steps:

To read the RSS feed updates, you need a reader, also called an aggregator. Readers can be Web based (for example, Google Reader), part of your browser (for example, Microsoft Internet Explorer, Mozilla Firefox), part of your e-mail client (for example, Microsoft Outlook), or installed on your computer. Web-based and e-mail client readers let you read RSS feeds from any computer. Feed subscriptions in your browser or reader software installed on your computer will be available only on the computer used to subscribe to the feeds.

The steps below describe how to subscribe to an RSS feed using MS Internet Explorer or Mozilla Firefox. The process may be slightly different for other browsers. Refer to your browser's help files for more information.

In your browser, create or open the RSS feed that you want to subscribe to. (See the instructions for creating an RSS Feed for a Specific Search.) To create an RSS feed for all studies on ClinicalTrials.gov, do not enter any words in the search boxes, click on Search or Search all studies (depending on which page you are on).

To practice subscribing to a feed for Recruiting studies on Huntington Disease using your browser, follow these steps:

After you have subscribed, you can view the RSS feed at any time using the same browser. The title of each feed item is the title of the study record that has been added or updated. Click on the title to open the study record page on ClinicalTrials.gov.

Your feed may be empty sometimes. This happens when there are no recent additions or updates to your original search results.

To delete the feed, right-click on it in your Feeds or Bookmarks list and select Delete.

In your browser, create or open the RSS feed that you want to subscribe to. (See the instructions for creating an RSS Feed for a Specific Search.) Copy the URL of the RSS feed page open in your browser and paste it into your feed reader application or software.

The process for subscribing to a feed varies, depending on the feed reader software. The feed reader's instructions should explain how to modify the RSS feed name or delete the feed.

Instead of subscribing to an RSS feed, you can use your browser to bookmark a Search Results page or label it as a "favorite." For example, a bookmarked Search Results page for studies on anticonvulsants recruiting in Chicago would appear as "Search of: Recruiting Studies | Anticonvulsants | United States, Illinois | Chicago - List Results - ClinicalTrials.gov" in your list of bookmarks or favorites. Each time you visit the page, you will see all the current results for your search, including records that have been recently added or updated and records that have not changed.

This page last reviewed in September 2017

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RSS Feeds - ClinicalTrials.gov

All cells have a programmed lifespan by which they are synthesized, multiply, and eventually undergo apoptosis (cell death) when they are no longer functional.

It often helps to think of cellular replication as old-fashioned photocopy machine: the more a cell copies itself, the more blurry and misaligned the image becomes. Over time, the genetic material of the cell (DNA) begins to fracture and the cell itself becomes a pale copy of the original. When this happens, programmed cell death allows a new cell to take over and keep the systems running.

The number of times a cell can divide is bounded by a phenomenon known as the Hayflick limit. This describes the action by which the process of division (known as mitosis) progressively degrades the genetic material, specifically the part of DNA called a telomere.

The Hayflick limit dictates that the average cell will divide between 50 to 70 times before apoptosis.

Chromosomes are thread-like structures located inside the nucleus of a cell. Each chromosome is made of protein and a single molecule of DNA.

At each end of a chromosome is a telomere which people will often compare to the plastic tips at the ends of a shoelace. Telomeres are important because they prevent chromosomes from unraveling, sticking to each other, or fusing into a ring.

Each time a cell divides, the double-stranded DNA separates in order for the genetic information to be copied. When this happens, the DNA coding is duplicated but not the telomere. When the copy is complete and mitosis begins, the place where the cell is snipped apart is at the telomere.

As such, with each cell generation, the telomere gets shorter and shorter until it can no longer maintain the integrity of the chromosome. It is then that apoptosis occurs.

Scientists can use the length of a telomere to determine the age of a cell and how many more replications it has left. As cellular division slows, it undergoes a progressive deterioration known as senescence, which we commonly refer to as aging. Cellular senescence explains why our organs and tissues begin to change as we grow older. In the end, all of our cells are "mortal" and subject to senescence.

All, that is, but one. Cancers cells are the one cell type that can truly be considered "immortal." Unlike normal cells, cancer cells do not undergo programmed cell death but can continue to multiply without end.

This, in and of itself, disrupts the balance of cellular replication in the body. If one type of cell is allowed to replicate unchecked, it can supplant all others and undermine key biological functions. This is what happens with cancer and why these "immortal" cells can cause disease and death.

It is believed that cancer occurs because a genetic mutation can trigger the production of an enzyme, known as telomerase, which prevents telomeres from shortening.

While every cell in the body has the genetic coding to produce telomerase, only certain cells actually need it. Sperm cells, for example, need to the switch off telomere shortening in order to make more than 50 copies of themselves; otherwise, pregnancy could never occur.

If a genetic mishap inadvertently turns telomerase production on, it can cause abnormal cells to multiply and form tumors. It is believed that as life expectancy rates continue to grow, the chances of this occur will not only become greater but eventually become inevitable.

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The Relationship Between Telomeres, Aging, and Cancer

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In this video Dr. Rhonda Patrick summarizes a recent study that found that frequency of sauna use was associated with decreased risk of death. Using the sauna 2-3 times per week was associated with 24% lower all-cause mortality and 4-7 times per week decreased all-cause mortality by 40%.

Rhonda discusses some possible mechanisms that could be responsible for the effect on longevity including the increased production of heat shock proteins (HSPs) and activation of the longevity gene, Foxo3. Heat stress increases the production of heat shock proteins, which prevent protein aggregation and protect against cardiovascular and neurodegenerative diseases. Heat stress also activates FOXO3, which activates many other genes that protect against the stress of aging including DNA damage, damage to proteins and lipids, loss of stem cell function, loss of immune function, cellular senescence and more.

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There is no shortage of clinics out there offering stem cell therapy. How much does stem cell therapy cost? How much is too much? Are you getting what you pay for? Lets dig in.

Our focus here on stem cell therapy cost is for orthopedic procedures as thats our area of expertise and something where we can benchmark and compare apples to apples. However, before we can get into that, we must first discuss different types of treatment, which can be broken down into a couple of categories. Stem cell therapy cost generally depends on:

Youll see dollar signs below by each item in each category which Ill explain how to use later.

Whats being injected is critical to determining stem cell therapy cost. However, who is injecting it and where the procedure is performed and other details will modify these costs. We can break this part down into:

Numbers 1 and 2 here are procedures where all of the injections are performed on the same day, while number 3 takes a few weeks to grow cells. The advertised cost of birth tissue procedures and same-day bone marrow or fat procedures are similar, usually in the 4-8K USD range. However, this is where we find our biggest opportunity for patient rip-offs. Let me explain.

The biggest problem that we encounter in these same-day stem cell procedures is when the product has no live cells, let alone stem cells. Multiple studies now by university and private scientists demonstrate that the amniotic fluid and umbilical cord products being hawked at seminars all over the US are all non-viable tissue. So, right upfront, youre actually getting massively overcharged if a clinic claims that this is a stem cell procedure. In fact, these birth tissue procedures are more similar to platelet-rich plasma injections as both contain growth factors that can help healing, but neither contain stem cells. PRP procedures run in 1-2K range for a single joint, so thats the appropriate price range for birth tissue procedures. To find out more about the issue with birth tissues being advertised as stem cells, see my video below:

Culture-expanded cells are grown to bigger numbers over 1-3 weeks and then injected. These procedures can not be performed legally in the US, so they are performed in other countries like the Cayman Islands, Panama, parts of Europe, or China as examples. They generally run 15-30K.

Stem cell therapy cost should be tied to who performs these procedures. Which medical providers commonly inject the cells?

We regrettably dont see a big correlation between stem cell therapy cost and the level of training of the provider performing the procedure. For example, a nurse practitioner (NP) or physicians assistant (PA) has about half of the training of the average physician specialist, but the cost of a stem cell procedure performed by a nurse is often similar to a specialist physician. Obviously, a medical provider with far less training should cost less than one with twice the training.

Stem cell therapy cost is often tied to the location where the procedure is performed. For example:

One of the most interesting things out there in the world of stem cell procedures is that we see procedures being performed outside of medical clinics and hospitals, often in alternative medicine clinics. The issue is that the level of sterility, regulation, safety equipment, and technology is higher in a medical setting, but often alternative health clinics run by chiropractors, naturopaths, and acupuncturists charge just as much or more than actual medical clinics who have better technology and more highly trained staff. Hence, a procedure in a place thats barely capable of supporting you as a patient if something goes wrong should cost much less than a place designed to help you with the latest technology and most highly trained staff.

Stem cell therapy cost should also be tied to how the procedure is performed and commonly there a few treatment delivery types out there:

Starting an IV doesnt take much expertise. In addition, if you get stem cells intravenous, 97% will end up in your lungs and few will end up where you have pain, Hence, you need to inject them locally. One way to do that would be to inject them blind, without imaging guidance, which also takes little expertise. However, there is no way to tell if the cells got to where they were supposed to be placed. Finally, you can use imaging guidance to ensure that the cells will get to the right spot. Thats either ultrasound or fluoroscopy (real-time x-ray) or both. As a rule, you should pay much less for an IV or blind injection and more for an image-guided injection.

Stem cell therapy cost is often directly tied to the number of spots that get injected. For example:

Most clinics that inject joints to treat arthritis will inject simply into the joint, which should cost less as thats less work. Some clinics will also inject multiple structures within the joint or around it, adding time and expertise to the procedure. Injecting multiple joints would be a similar increase in work. Finally, some clinics will also inject multiple areas in and around multiple joints, which would be the most expensive.

To figure out the stem cell therapy cost take the price range above and apply the dollar sign modifiers. So single dollar signs should push you toward the low end of the price range and double or triple towards the higher end. Now lets take some concrete examples.

Example 1: A common stem cell procedure performed in a local chiropractors office.

As discussed above, the right price for birth tissues is about what you would pay for PRP, so thats 1-2K. All of these single dollars signs would push you toward a cost thats lower than the average stem cell therapy price. Hence, this is about a 1-2K procedure.

Now lets go to the other end of that spectrum: A bone marrow concentrate procedure delivered by a physician specialist in a medical office:

Same day bone marrow stem cell procedures run in the 4-8K range. All of these two dollars signs would push you toward the higher end of that range.

Obviously, we have dramatic differences in what I priced out above. The chiro clinic with a nurse injecting birth tissues blindly in a clinic not designed for this type of work is a lower quality affair. The opposite is true with my second example. So like anything else in life, you get what you pay for.

To learn more about how to choose the right stem cell clinic based on quality, read my mini-book on the topic (click on the book cover to download the PDF):

The upshot? Figuring out stem cell therapy cost is not that hard, you just need to know what it is youre buying. Just like that fake Gucci purse that looks good but falls apart in a few months, or that real one that lasts a lifetime, how much you spend is usually associated with the quality of what you buy. However, use the dollar signs to see if the stem cell procedure youre buying is over or underpriced!

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Stem Cell Therapy Cost? - Regenexx

The sun emits three kinds of ultraviolet radiation: UVA, UVB and UVC. While UVC is absorbed by the Earths atmosphere, UVB radiation is only partially blocked and can burn the skin and eyes. UVA rays are not filtered and cause the most damage to vision health, according to the World Health Organization.

The Vision Councils most recent VisionWatch survey reveals American adults experience symptoms like irritation in the eye (15.5 percent), trouble seeing (13.5 percent), wrinkles around the eye (8.3 percent), red or swollen eyes (5.9 percent), sunburn on the eyelids (3.7 percent), sunburn of the eye (2.5 percent) and cancer on or around the eye (.6 percent) from prolonged UV exposure. Additionally, the most common time American adults report spending time outdoors is 2-4 p.m. (39.8 percent), and the number one thing that concerns them most about UV eye exposure is vision loss (28.2 percent). However, 27 percent report they dont typically wear sunglasses when they are outside.

Additional findings show:

Q: Does the darkness of the lenses equate to higher UV protection?A: No. However, 39.4 percent of American adults believe it does. Dark lenses without adequate UV protection can be worse than wearing no sunglasses at all because they cause the eye's pupil to dilate, which then increases retinal exposure to unfiltered UV.

Q: Do all sunglasses offer UVA/UVB protection?A: No. Since shielding the eyes from damaging radiation is crucial, it is imperative to look for a label, sticker or tag indicating UV protection before purchasing a pair of sunglasses.

Q: When do UV rays affect the eyes?A: UV radiation is present year-round, so despite the season or weather. So it's important to wear proper eye and skin protection while outside during daylight hours.

Q: What should be considered when purchasing a pair of sunglasses?A: Protection, daily activities, comfort and personal style.

The Vision Council encourages everyone to wear sunglasses whenever they're outdoors during daylight hours, and to have an annual eye exam with an eyecare provider. Only 27 percent of American adults report they have an annual eye exam and talk to their eyecare provider about UV eye protection, and 29.7 percent report their child(ren) has an annual eye exam and talk to their eyecare provider about their UV eye protection. However, eyecare providers can make recommendations regarding sunglasses tailored to an individuals unique vision and lifestyle needs. Additionally, sunglasses are also considered a style accessory that can elevate any look! Individuals should start a collection to coincide with their varying activities and ever-changing wardrobes.

Don't forget to celebrate National Sunglasses Day on June 27 by posting a photo with your favorite sunglasses tagging @TheVisionCouncil, and using #NationalSunglassesDay and #SunglassSelfie. For more information, visit nationalsunglassesday.com.

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UV Eye Protection | The Vision Council

The Center For Sight: Lufkin TX Eye Care Surgery, Lenses & More Our desire is to be your trusted choice in eye care.

Welcome to The Center For Sight

In 1981, Dr. Richard J. Ruckman opened The Center For Sights first location in Lufkin, Texas with a vision to provide his patients with high-level eye care through enhanced technology, skilled professionals and his personal commitment to excellence. Since then, The Center For Sight has grown to serve East Texas with its main office in Lufkin ,and satellite office in Livingston.

The mission of The Center For Sight has been, Our Focus is You! We strive to make our patients feel like our family and to provide all levels of eye care, including eye examinations, contact lens evaluations and fittings, complex medical evaluations, cataract surgery and prescription glasses. Our team of doctors and staff is among the finest, and we work hard to preserve and improve the vision and health of each and every one of our patients. Our desire is to be your trusted choice in eye care. Welcome to The Center For Sight!

Visit Both of Our Locations!

We have two locations for your convenience. Located in Lufkin and Livingston, we're ready to provide you with an exceptional experience, no matter which location you visit! Get quality eye care, whether you need contact lenses or eye surgery. Call today to schedule an appointment!

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Abstract

Stem cell research offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinsons disease, and myocardial infarction. However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes about the onset of human personhood. The reprogramming of somatic cells to produce induced pluripotent stem cells avoids the ethical problems specific to embryonic stem cell research. In any hSC research, however, difficult dilemmas arise regarding sensitive downstream research, consent to donate materials for hSC research, early clinical trials of hSC therapies, and oversight of hSC research. These ethical and policy issues need to be discussed along with scientific challenges to ensure that stem cell research is carried out in an ethically appropriate manner. This article provides a critical analysis of these issues and how they are addressed in current policies.

I.

Introduction

II.

Multipotent Stem Cells

A.

Cord blood stem cells

B.

Adult blood stem cells

III.

Embryonic Stem Cell Research

A.

Existing embryonic stem cell lines

B.

New embryonic stem cell lines from frozen embryos

C.

Ethical concerns about oocyte donation for research

IV.

Somatic Cell Nuclear Transfer (SCNT)

V.

Fetal Stem Cells

VI.

Induced Pluripotent Stem Cells (iPS Cells)

VII.

Stem Cell Clinical Trials

VIII.

Institutional Oversight of Stem Cell Research

STEM CELL RESEARCH offers great promise for understanding basic mechanisms of human development and differentiation, as well as the hope for new treatments for diseases such as diabetes, spinal cord injury, Parkinsons disease, and myocardial infarction (1). Pluripotent stem cells perpetuate themselves in culture and can differentiate into all types of specialized cells. Scientists plan to differentiate pluripotent cells into specialized cells that could be used for transplantation.

However, human stem cell (hSC) research also raises sharp ethical and political controversies. The derivation of pluripotent stem cell lines from oocytes and embryos is fraught with disputes regarding the onset of human personhood and human reproduction. Several other methods of deriving stem cells raise fewer ethical concerns. The reprogramming of somatic cells to produce induced pluripotent stem cells (iPS cells) avoids the ethical problems specific to embryonic stem cells. With any hSC research, however, there are difficult dilemmas, including consent to donate materials for hSC research, early clinical trials of hSC therapies, and oversight of hSC research (2). Table 1 summarizes the ethical issues that arise at different phases of stem cell research.

TABLE 1

Ethical issues at different phases of stem cell research

TABLE 1

Ethical issues at different phases of stem cell research

Adult stem cells and cord blood stem cells do not raise special ethical concerns and are widely used in research and clinical care. However, these cells cannot be expanded in vitro and have not been definitively shown to be pluripotent.

Hematopoietic stem cells from cord blood can be banked and are widely used for allogenic and autologous stem cell transplantation in pediatric hematological diseases as an alternative to bone marrow transplantation.

Adult stem cells occur in many tissues and can differentiate into specialized cells in their tissue of origin and also transdifferentiate into specialized cells characteristic of other tissues. For example, hematopoietic stem cells can differentiate into all three blood cell types as well as into neural stem cells, cardiomyocytes, and liver cells.

Adult stem cells can be isolated through plasmapheresis. They are already used to treat hematological malignancies and to modify the side effects of cancer chemotherapy. Furthermore, autologous stem cells are being used in clinical trials in patients who have suffered myocardial infarction. Their use in several other conditions has not been validated or is experimental, despite some claims to the contrary (3).

Pluripotent stem cell lines can be derived from the inner cell mass of the 5- to 7-d-old blastocyst. However, human embryonic stem cell (hESC) research is ethically and politically controversial because it involves the destruction of human embryos. In the United States, the question of when human life begins has been highly controversial and closely linked to debates over abortion. It is not disputed that embryos have the potential to become human beings; if implanted into a womans uterus at the appropriate hormonal phase, an embryo could implant, develop into a fetus, and become a live-born child.

Some people, however, believe that an embryo is a person with the same moral status as an adult or a live-born child. As a matter of religious faith and moral conviction, they believe that human life begins at conception and that an embryo is therefore a person. According to this view, an embryo has interests and rights that must be respected. From this perspective, taking a blastocyst and removing the inner cell mass to derive an embryonic stem cell line is tantamount to murder (4).

Many other people have a different view of the moral status of the embryo, for example that the embryo becomes a person in a moral sense at a later stage of development than fertilization. Few people, however, believe that the embryo or blastocyst is just a clump of cells that can be used for research without restriction. Many hold a middle ground that the early embryo deserves special respect as a potential human being but that it is acceptable to use it for certain types of research provided there is good scientific justification, careful oversight, and informed consent from the woman or couple for donating the embryo for research (5).

Opposition to hESC research is often associated with opposition to abortion and with the pro-life movement. However, such opposition to stem cell research is not monolithic. A number of pro-life leaders support stem cell research using frozen embryos that remain after a woman or couple has completed infertility treatment and that they have decided not to give to another couple. This view is held, for example, by former First Lady Nancy Reagan and by U.S. Senator Orrin Hatch.

On his Senate website, Sen. Hatch states: The support of embryonic stem cell research is consistent with pro-life, pro-family values.

I believe that human life begins in the womb, not a Petri dish or refrigerator . To me, the morality of the situation dictates that these embryos, which are routinely discarded, be used to improve and save lives. The tragedy would be in not using these embryos to save lives when the alternative is that they would be discarded (6).

In 2001, President Bush, who holds strong pro-life views, allowed federal National Institutes of Health (NIH) funding for stem cell research using embryonic stem cell lines already in existence at the time, while prohibiting NIH funding for the derivation or use of additional embryonic stem cell lines. This policy was a response to a growing sense that hESC research held great promise for understanding and treating degenerative diseases, while still opposing further destruction of human embryos. NIH funding was viewed by many researchers as essential for attracting scientists to make a long-term commitment to study the basic biology of stem cells; without a strong basic science platform, therapeutic breakthroughs would be less likely.

President Bushs rationale for this policy was that the embryos from which these lines were produced had already been destroyed. Allowing research to be carried out on the stem cell lines might allow some good to come out of their destruction. However, using only existing embryonic stem cell lines is scientifically problematic. Originally, the NIH announced that over 60 hESC lines would be acceptable for NIH funding. However, the majority of these lines were not suitable for research; for example, they were not truly pluripotent, had become contaminated, or were not available for shipping. As of January 2009, 22 hESC lines are eligible for NIH funding. However, these lines may not be safe for transplantation into humans, and long-standing lines have been shown to accumulate mutations, including several known to predispose to cancer. In addition, concerns have been raised about the consent process for the derivation of some of these NIH-approved lines (7). The vast majority of scientific experts, including the Director of the NIH under President Bush, believe that a lack of access to new embryonic stem cell lines hinders progress toward stem cell-based transplantation (8). For example, lines from a wider range of donors would allow more patients to receive human leukocyte agent matched stem cell transplants (9).

Currently, federal funds may not be used to derive new embryonic stem cell lines or to work with hESC lines not on the approved NIH list. NIH-funded equipment and laboratory space may not be used for research on nonapproved hESC lines. Both the derivation of new hESC lines and research with hESC lines not approved by NIH may be carried out under nonfederal funding. Because of these restrictions on NIH funding, a number of states have established programs to fund stem cell research, including the derivation of new embryonic stem cell lines. California, for example, has allocated $3 billion over 10 yr to stem cell research.

Under President Obama, it is expected that federal funding will be made available to carry out research with hESC lines not on the NIH list and to derive new hESC lines from frozen embryos donated for research after a woman or couple using in vitro fertilization (IVF) has determined they are no longer needed for reproductive purposes. However, federal funding may not be permitted for creation of embryos expressly for research or for derivation of stem cell lines using somatic cell nuclear transfer (SCNT) (10, 11).

Women and couples who undergo infertility treatment often have frozen embryos remaining after they complete their infertility treatment. The disposition of these frozen embryos is often a difficult decision for them to make (12). Some choose to donate these remaining embryos to research rather than giving them to another couple for reproductive purposes or destroying them. Several ethical concerns come into play when a frozen embryo is donated, including informed consent from the woman or couple donating the embryo, consent from gamete donors involved in the creation of the embryo, and the confidentiality of donor information.

Since the Nuremburg Code, informed consent has been regarded as a basic requirement for research with human subjects. Consent is particularly important in research with human embryos (13). Members of the public and potential donors of embryos for research hold strong and diverse opinions on the matter. Some consider all embryo research to be unacceptable; others only support some forms of research. For instance, a person might consider infertility research acceptable but object to research to derive stem cell lines or research that might lead to patents or commercial products (14). Obtaining informed consent for potential future uses of the donated embryo respects this diversity of views. Additionally, people commonly place special emotional and moral significance on their reproductive materials, compared with other tissues (15).

In the United States, federal regulations on research permit a waiver of informed consent for the research use of deidentified biological materials that cannot be linked to donors (16). Thus, logistically it would be possible to carry out embryo and stem cell research on deidentified materials without consent. For example, during IVF procedures, oocytes that fail to fertilize or embryos that fail to develop sufficiently to be implanted are ordinarily discarded. These materials could be deidentified and then used by researchers. Furthermore, if infertility patients have frozen embryos remaining after they complete treatment, they are routinely contacted by the IVF program to decide whether they want to continue to store the embryos (and to pay freezer storage fees), to donate them to another infertile woman or couple, or to discard them. If a patient chooses to discard the embryos, it would be possible to instead remove identifiers and use them for research. Still another possibility involves frozen embryos from patients who do not respond to requests to make a decision regarding the disposition of frozen embryos. Some IVF practices have a policy to discard such embryos and inform patients of this policy when they give consent for the IVF procedures. Again, rather than discard such frozen embryos, it is logistically feasible to deidentify them and give them to researchers.

However, the ethical justifications for allowing deidentified biological materials to be used for research without consent do not always hold for embryo research (13). For example, one rationale for allowing the use of deidentified materials is that the ethical risks are very low; there can be no breach of confidentiality, which is the main concern in this type of research. A second rationale is that people would not object to having their materials used in such a manner if they were asked. However, this assumption does not necessarily hold in the context of embryo research. A 2007 study found that 49% of women with frozen embryos would be willing to donate them for research (12). Such donors might be offended or feel wronged if their frozen embryos were used for research that they did not consent to. Deidentifying the materials would not address their concerns.

Frozen embryos may be created with sperm or oocytes from donors who do not participate any further in assisted reproduction or childrearing. Some people argue that consent from gamete donors is not required for embryo research because they have ceded their right to direct further usage of their gametes to the artificial reproductive technology (ART) patients. However, gamete donors who are willing to help women and couples bear children may object to the use of their genetic materials for research. In one study, 25% of women who donated oocytes for infertility treatment did not want the embryos created to be used for research (17). This percentage is not unexpected because reproductive materials have special significance, and many people in the United States oppose embryo research. Little is known about the wishes of sperm donors concerning research.

There are substantial practical differences between obtaining consent for embryo research from oocyte donors and from sperm donors. ART clinics can readily discuss donation for research with oocyte donors during visits for oocyte stimulation and retrieval. However, most ART clinics obtain donor sperm from sperm banks and generally have no direct contact with the donors. Furthermore, sperm is often donated anonymously to sperm banks, with strict confidentiality provisions.

As a matter of respect for gamete donors, their wishes regarding stem cell derivation should be determined and respected (13). Gamete donors who are willing to help women and couples bear children may object to the use of their genetic materials for research. Specific consent for stem cell research from both embryo and gamete donors was recommended by the National Academy of Sciences 2005 Guidelines for Human Embryonic Stem Cell Research and has been adopted by the California Institute for Regenerative Medicine (CIRM), the state agency funding stem cell research (18, 19). This consent requirement need not imply that embryos are people or that gametes or embryos are research subjects.

Confidentiality must be carefully protected in embryo and hESC research because breaches of confidentiality might subject donors to unwanted publicity or even harassment by opponents of hESC research (20). Although identifying information about donors must be retained in case of audits by the Food and Drug Administration as part of the approval process for new therapies, concerns about confidentiality may deter some donors from agreeing to be recontacted.

Recently, confidentiality of personal health care information has been violated through deliberate breaches by staff, through break-ins by computer hackers, and through loss or theft of laptop computers. Files containing the identities of persons whose gametes or embryos were used to derive hESC lines should be protected through heightened security measures (20). Any computer storing such files should be locked in a secure room and password-protected, with access limited to a minimum number of individuals on a strict need-to-know basis. Entry to the computer storage room should also be restricted by means of a card-key, or equivalent system, that records each entry. Audit trails of access to the information should be routinely monitored for inappropriate access. The files with identifiers should be copy-protected and double encrypted, with one of the keys held by a high-ranking institutional official who is not involved in stem cell research. The computer storing these data should not be connected to the Internet. To protect information from subpoena, investigators should obtain a federal Certificate of Confidentiality. Human factors in breaches of confidentiality should also be considered. Personnel who have access to these identifiers might receive additional background checks, interviews, and training. The personnel responsible for maintaining this confidential database and contacting any donor should not be part of any research team.

hESC research using fresh oocytes donated for research raises several additional ethical concerns as well, as we next discuss (21).

Concerns about oocyte donation specifically for research are particularly serious in the wake of the Hwang scandal in South Korea, in which widely hailed claims of deriving human SCNT lines were fabricated. In addition to scientific fraud, the scandal involved inappropriate payments to oocyte donors, serious deficiencies in the informed consent process, undue influence on staff and junior scientists to serve as donors, and an unacceptably high incidence of medical complications from oocyte donation (2224). In California, some legislators and members of the public have charged that infertility clinics downplay the risks of oocyte donation (19). CIRM has put in place several protections for women donating oocytes in state-funded stem cell research.

The medical risks of oocyte retrieval include ovarian hyperstimulation syndrome, bleeding, infection, and complications of anesthesia (25). These risks may be minimized by the exclusion of donors at high-risk for these complications, careful monitoring of the number of developing follicles, and adjusting the dose of human chorionic gonadotropin administered to induce ovulation or canceling the cycle (25).

Because severe hyperovulation syndrome may require hospitalization or surgery, women donating oocytes for research should be protected against the costs of complications of hormonal stimulation and oocyte retrieval (19). The United States does not have universal health insurance. As a matter of fairness, women who undergo an invasive procedure for the benefit of science and who are not receiving payment beyond expenses should not bear any costs for the treatment of complications. Even if a woman has health insurance, copayments and deductibles might be substantial, and if she later applied for individual-rated health insurance, her premiums might be prohibitive. Compensation for research injuries has been recommended by several U.S. panels (26) but has not been adopted because of difficulties calculating long-term actuarial risk and assessing intervening factors that could contribute to or cause adverse events.

Requiring free care for short-term complications of oocyte donation is feasible. In California, research institutions must ensure free treatment to oocyte donors for direct and proximate medical complications of oocyte retrieval in state-funded research. The term direct and proximate is a legal concept to determine how closely an injury needs to be connected to an event or condition to assign responsibility for the injury to the person who carried out the event or created the condition. Commercial insurance policies are available to cover short-term complications of oocyte retrieval. CIRM allows state stem cell grants to cover the cost of such insurance. The rationale for making research institutions responsible for treatment is that they are in a better position than individual researchers to identify insurance policies and would have an incentive to consider extending such coverage to other research injuries.

If women in infertility treatment share oocytes with researcherseither their own oocytes or those from an oocyte donortheir prospect of reproductive success may be compromised because fewer oocytes are available for reproductive purposes (21). In this situation, the physician carrying out oocyte retrieval and infertility care should give priority to the reproductive needs of the patient in IVF. The highest quality oocytes should be used for reproductive purposes (21).

As discussed in Section B. 2, in IVF programs some oocytes fail to fertilize, and some embryos fail to develop sufficiently to be implanted. Such materials may be donated to researchers. To protect the reproductive interests of donors, several safeguards should be in place (20). For the donation of fresh embryos for research, the determination by the embryologist that an embryo is not suitable for implantation and therefore should be discarded is a matter of judgment. Similarly, the determination that an oocyte has failed to fertilize and thus cannot be used for reproduction is a judgment call. To avoid any conflict of interest, the embryologist should not know whether a woman has agreed to research donation and also should receive no funding from grants associated with the research. Furthermore, the treating infertility physicians should not know whether or not their patients agree to donate materials for research.

Many jurisdictions have conflicting policies about payment to oocyte donors. Reimbursement to oocyte donors for out-of-pocket expenses presents no ethical problems because donors gain no financial advantage from participating in research. However, payment to oocyte donors in excess of reasonable out-of-pocket expenses is controversial, and jurisdictions have conflicting policies that may also be internally inconsistent (27, 28).

Good arguments can be made both for and against paying donors of research oocytes more than their expenses (29). On the one hand, some object that such payments induce women to undertake excessive risks, particularly poorly educated women who have limited options for employment, as occurred in the Hwang scandal. Such concerns about undue influence, however, may be addressed without banning payment. For example, participants could be asked questions to ensure that they understood key features of the study and that they felt they had a choice regarding participation (19). Also, careful monitoring and adjustment of hormone doses can minimize the risks associated with oocyte donation (25). A further objection is that paying women who provide research oocytes undermines human dignity because human biological materials and intimate relationships are devalued if these materials are bought and sold like commodities (14, 30).

On the other hand, some contend that it is unfair to ban payments to donors of research oocytes, while allowing women to receive thousands of U.S. dollars to undergo the same procedures to provide oocytes for infertility treatment (29). Moreover, healthy volunteers, both men and women, are paid to undergo other invasive research procedures, such as liver biopsy, for research purposes. Furthermore, bans on payment for oocyte donation for research have been criticized as paternalistic, denying women the authority to make decisions for themselves (31). On a pragmatic level, without such payment, it is very difficult to recruit oocyte donors for research.

In California, CIRM has instituted heightened requirements for informed consent for oocyte donation for research (19). The CIRM regulations go beyond requirements for disclosure of information to oocyte donors (19). The major ethical issue is whether donors appreciate key information about oocyte donation, not simply whether the information has been disclosed to them or not. As discussed previously, in other research settings, research participants often fail to understand the information in detailed consent forms (32). CIRM thus reasons that disclosure, while necessary, is not sufficient to guarantee informed consent. In CIRM-funded research, oocyte donors must be asked questions to ensure that they comprehend the key features of the research (19). Evaluating comprehension is feasible because it has been carried out in other research contexts, such as in HIV prevention trials in the developing world (33). According to testimony presented to CIRM, evaluation of comprehension has also been carried out with respect to oocyte donation for clinical infertility services.

Pluripotent stem cell lines whose nuclear DNA matches a specific person have several scientific advantages. Stem cell lines matched to persons with specific diseases can serve as in vitro models of diseases, elucidate the pathophysiology of diseases, and screen potential new therapies. Lines matched to specific individuals also offer the promise of personalized autologous stem cell transplantation.

One approach to creating such lines is through SCNT, the technique that produced Dolly the sheep. In SCNT, reprogramming is achieved after transferring nuclear DNA from a donor cell into an oocyte from which the nucleus has been removed. However, creating human SCNT stem cell lines has not only been scientifically impossible to date but is also ethically controversial (34, 35).

Some people who object to SCNT believe that creating embryos with the intention of using them for research and destroying them in that process violates respect for nascent human life. Even those who support deriving stem cell lines from frozen embryos that would otherwise be discarded sometimes reject the intentional creation of embryos for research. In rebuttal, however, some argue that pluripotent entities created through SCNT are biologically and ethically distinct from embryos (36).

There are several compelling objections to using SCNT for human reproduction. First, because of errors during reprogramming of genetic material, cloned animal embryos fail to activate key embryonic genes, and newborn clones misexpress hundreds of genes (37, 38). The risk of severe congenital defects would be prohibitively high in humans. Second, even if SCNT could be carried out safely in humans, some object that it violates human dignity and undermines traditional, fundamental moral, religious, and cultural values (34). A cloned child would have only one genetic parent and would be the genetic twin of that parent. In this view, cloning would lead children to be regarded more as products of a designed manufacturing process than gifts whom their parents are prepared to accept as they are. Furthermore, cloning would violate the natural boundaries between generations (34). For these reasons, cloning for reproductive purposes is widely considered morally wrong and is illegal in a number of states. Moreover, some people argue that because the technique of SCNT can be used for reproduction, its development and use for basic research should be banned.

Because of the shortage of human oocytes for SCNT research, some scientists wish to use nonhuman oocytes to derive lines using human nuclear DNA. These so-called cytoplasmic hybrid embryos raise a number of ethical concerns. Some opponents fear the creation of chimerasmythical beasts that appear part human and part animal and have characteristics of both humans and animals (39). Opponents may feel deep moral unease or repugnance, without articulating their concerns in more specific terms. Some people view such hybrid embryos as contrary to a moral order embodied in the natural world and in natural law. In this view, each species has a particular moral purpose or goal, which mankind should not try to change. Others view such research as an inappropriate crossing of species barriers, which should be an immutable part of natural design. Finally, some are concerned that there may be attempts to implant these embryos for reproductive purposes.

In rebuttal, supporters of such research point out that the biological definitions of species are not natural and immutable but empirical and pragmatic (4042). Animal-animal hybrids of various sorts, such as the mule, exist and are not considered morally objectionable. Moreover, in medical research, human cells are commonly injected into nonhuman animals and incorporated into their functioning tissue. Indeed, this is widely done in research with all types of stem cells to demonstrate that cells are pluripotent or have differentiated into the desired type of cell. In addition, some concerns can be addressed through strict oversight (40), for example prohibiting reproductive uses of these embryos and limiting in vitro development to 14 d or the development of the primitive streak, limits that are widely accepted for other hESC research. Finally, some people regard repugnance per se an unconvincing guide to ethical judgments. People disagree over what is repugnant, and their views might change over time. Blood transfusion and cadaveric organ transplantation were originally viewed as repugnant but are now widely accepted practices. Furthermore, after public discussion and education, many people overcome their initial concerns.

Pluripotent stem cells can be derived from fetal tissue after abortion. However, use of fetal tissue is ethically controversial because it is associated with abortion, which many people object to. Under federal regulations, research with fetal tissue is permitted provided that the donation of tissue for research is considered only after the decision to terminate pregnancy has been made. This requirement minimizes the possibility that a womans decision to terminate pregnancy might be influenced by the prospect of contributing tissue to research. Currently there is a phase 1 clinical trial in Battens disease, a lethal degenerative disease affecting children, using neural stem cells derived from fetal tissue (43, 44).

Somatic cells can be reprogrammed to form pluripotent stem cells (45, 46), called induced pluripotential stem cells (iPS cells). These iPS cell lines will have DNA matching that of the somatic cell donors and will be useful as disease models and potentially for allogenic transplantation.

Early iPS cell lines were derived by inserting genes encoding for transcription factors, using retroviral vectors. Researchers have been trying to eliminate safety concerns about inserting oncogenes and insertional mutagenesis. Reprogramming has been successfully accomplished without known oncogenes and using adenovirus vectors rather than retrovirus vectors. A further step was the recent demonstration that human embryonic fibroblasts can be reprogrammed to a pluripotent state using a plasmid with a peptide-linked reprogramming cassette (47, 48). Not only was reprogramming accomplished without using a virus, but the transgene can be removed after reprogramming is accomplished. The ultimate goal is to induce pluripotentiality without genetic manipulation. Because of unresolved problems with iPS cells, which currently preclude their use for cell-based therapies, most scientists urge continued research with hESC (49).

iPS cells avoid the heated debates over the ethics of embryonic stem cell research because embryos or oocytes are not used. Furthermore, because a skin biopsy to obtain somatic cells is relatively noninvasive, there are fewer concerns about risks to donors compared with oocyte donation. The Presidents Council on Bioethics called iPS cells ethically unproblematic and acceptable for use in humans (39). Neither the donation of materials to derive iPS cells nor their derivation raises special ethical issues.

Some potential downstream uses of iPS cell derivatives may be so sensitive as to call into question whether the original somatic cell donors would have agreed to such uses (50). iPS cells will be shared widely among researchers who will carry out a variety of studies with iPS cells and derivatives, using common and well-accepted scientific practices, such as:

Genetic modifications of cells

Injection of derived cells into nonhuman animals to demonstrate their function, including the injection into the brains of nonhuman animals.

Large-scale genome sequencing

Sharing cell lines with other researchers, with appropriate confidentiality protections, and

Patenting scientific discoveries and developing commercial tests and therapies, with no sharing of royalties with donors (51).

These standard research techniques are widely used in other types of basic research, including research with stem cells from other sources. Generally, donors of biological materials are not explicitly informed of these research procedures, although such disclosure is now proposed for whole genome sequencing (52, 53).

Such studies are of fundamental importance in stem cell biology, for example to characterize the lines and to demonstrate that they are pluripotent. Large-scale genome sequencing will yield insights about the pathogenesis of disease and identify new targets for therapy. Injection of human stem cells into the brains of nonhuman animals will be required for preclinical testing of cell-based therapies for many conditions, such as Parkinsons disease, Alzheimers disease, and stroke.

However, some downstream research could also raise ethical concerns. For example, large-scale genome sequencing may evoke concerns about privacy and confidentiality. Donors might consider it a violation of privacy if scientists know their future susceptibility to many genetic diseases. Furthermore, it may be possible to reidentify the donor of a deidentified large-scale genome sequence using information in forensic DNA databases or at an Internet company offering personal genomic testing (54, 55). Other donors may object to their cells being injected into animals. For example, they may oppose all animal research, or they may have religious objections to the mixing of human and animal species. The injection of human neural progenitor cells into nonhuman animals has raised ethical concerns about animals developing characteristics considered uniquely human (56, 57). Still other donors may not want cell lines derived from their biological materials to be patented as a step toward developing new tests and therapies. People are unlikely to drop such objections even if the cell lines were deidentified or even if many years had passed since the original donation. Thus there may be a tension between respecting the autonomy of donors and obtaining scientific benefit from research, which can be resolved during the process of obtaining consent for the original donation of materials.

It would be unfortunate if iPS cell lines that turned out to be extremely useful scientifically (for example because of robust growth in tissue culture) could not be used in additional research because the somatic cell donor objected. One approach to avoid this is to preferentially use somatic cells from donors who are willing to allow all such basic stem cell research and to be contacted for future sensitive research that cannot be anticipated at the time of consent (50). Donors could also be offered the option of consenting to additional specific types of sensitive but not fundamental downstream research, such as allogenic transplantation into other humans and reproductive research involving the creation of totipotent entities.

Because these concerns about consent for sensitive downstream research also apply to other types of stem cells, it would be prudent to put in place similar standards for consent to donate materials for derivation of other types of stem cells. However, these concerns are particularly salient for iPS cells because of the widespread perception that these cells raise no serious ethical problems and because they are likely to play an increasing role in stem cell research.

Transplantation of cells derived from pluripotent stem cells offers the promise of effective new treatments. However, such transplantation also involves great uncertainty and the possibility of serious risks. Some stem cell therapies have been shown to be effective and safe, for example hematopoietic stem cell transplants for leukemia and epithelial stem cell-based treatments for burns and corneal disorders (58). However, there are some clinics around the world already exploiting patients hopes by purporting to offer effective stem cell therapies for seriously ill patients, typically for large sums of money, but without credible scientific rationale, transparency, oversight, or patient protections (58). Although supporting medical innovation under very limited circumstances, the International Society for Stem Cell Research has decried such use of unproven hSC transplantation.

These clinical trials should follow ethical principles that guide all clinical research, including appropriate balance of risks and benefits and informed, voluntary consent. Additional ethical requirements are also warranted to strengthen trial design, coordinate scientific and ethics review, verify that participants understand key features of the trial, and ensure publication of negative findings (59). These measures are appropriate because of the highly innovative nature of the intervention, limited experience in humans, and the high hopes of patients who have no effective treatments.

The risks of innovative stem cell-based interventions include tumor formation, immunological reactions, unexpected behavior of the cells, and unknown long-term health effects (58). Evidence of safety and proof of principle should be established through appropriate preclinical studies in relevant animal models or through human studies of similar cell-based interventions. Requirements for proof of principle and safety should be higher if cells have been manipulated extensively in vitro or have been derived from pluripotent stem cells (58).

Even with these safeguards, however, because of the highly innovative nature of the intervention and limited experience in humans, unanticipated serious adverse events may occur. In older clinical trials of transplantation of fetal dopaminergic neurons into persons with Parkinsons disease, transplanted cells failed to improve clinical outcomes (60, 61). Indeed, about 15% of subjects receiving transplantation late developed disabling dyskinesias, with some needing ablative surgery to relieve these adverse events (60, 61). Although the transplanted cells localized to the target areas of the brain, engrafted, and functioned to produce the intended neurotransmitters, appropriately regulated physiological function was not achieved. Participants in phase I trials may not thoroughly understand the possibility that hESC transplantation might make their condition worse.

Problems with informed consent are well documented in phase I clinical trials. Participants in cancer clinical trials commonly expect that they will benefit personally from the trial, although the primary purpose of phase I trials is to test safety rather than efficacy (62). This tendency to view clinical research as providing personal benefit has been termed the therapeutic misconception (32, 63). Analyses of cancer clinical trials reveal that the information in consent forms generally is adequate. However, in early phase I gene transfer clinical trials, researchers descriptions of the direct benefit to participants commonly were vague, ambiguous, and indeterminate (64).

Participants in phase I stem cell-based clinical trials might overestimate their benefits and underestimate the risks. The scientific rationale for hSC transplantation and preclinical results may seem compelling. In addition, highly optimistic press coverage might reinforce unrealistic hopes.

Several measures may enhance informed consent in early stem cell-based clinical trials (59). First, researchers should describe the risks and prospective benefits in a realistic manner. Researchers need to communicate the distinction between the long-term hope for effective treatments and the uncertainty inherent in any phase I trial. Participants in phase I studies need to understand that the intervention has never been tried before in humans for the specific condition, that researchers do not know whether it will work as hoped, and that the great majority of participants in phase I studies do not receive a direct benefit.

Second, investigators in hESC clinical trials should discuss a broader range of information with potential participants than in other clinical trials. The doctrine of informed consent requires researchers to discuss with potential participants information that is pertinent to their decision to volunteer for the clinical trial (65). Generally, the relevant information concerns the nature of the intervention being studied and the risks and prospective benefits. However, in hESC transplantation, nonmedical issues may be prominent or even decisive for some participants. Individuals who regard the embryo as having the moral status of a person would likely have strong objections to receiving hESC transplants. Although this intervention might benefit them medically, such individuals might regard it as complicit with an immoral action. Thus researchers in clinical trials of hESC transplantation should inform eligible participants that transplanted materials originated from human embryos.

Third, and most important, researchers should verify that participants have a realistic understanding of the clinical trial (59). The crucial ethical issue about informed consent is not what researchers disclose in consent forms or discussions, but rather what the participants in clinical trials understand. In other contexts, some researchers have ensured that participants understand the key features of the trial by assessing their comprehension. In HIV clinical trials in developing countries, where it has been alleged that participants did not understand the trial, many researchers are now testing each participant to be sure he or she understands the essential features of the research (33). Such direct assessment of participants understanding of the study has been recommended more broadly in contexts in which misunderstandings are likely (26). We urge that such tests of comprehension be carried out in phase I trials of hSC transplantation (58, 59).

Careful attention to consent in highly innovative clinical trials might prevent controversies later. In early clinical trials of organ transplantation, the implantable totally artificial heart, and gene transfer, the occurrence of serious adverse events led to allegations that study participants had not truly understood the nature of the research (6668). The resulting ethical controversies brought about negative publicity and delays in subsequent clinical trials.

Human stem cell research raises some ethical issues that are beyond the mission of institutional review boards (IRBs) to protect human subjects, as well as the expertise of IRB members. There should be a sound scientific justification for using human oocytes and embryos to derive new human stem cell lines. However, IRBs usually do not carry out in-depth scientific review. Some ethical issues in hESC research do not involve human subjects protection, for example the concern that transplanting human stem cells into nonhuman animals might result in characteristics that are regarded as uniquely human.

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