StemCell Therapy

South Korean Hwang Woo Suk was long regarded as a cloning pioneer - until he was charged with having faked much of his stem cell research. Now, he is back with a new project: he wants to clone a woolly mammoth.

South Korean researcher and cloning pioneer Hwang Woo Suk hasn't been in the scientific spotlight ever since he claimed to have successfully created human embryonic stem cells by cloning six years ago, and that research turned out to be fake.

Now, the controversial veterinarian and researcher is in the headlines again. He wants to use frozen tissue samples to recreate an animal that last walked the earth some 10,000 years ago: a woolly mammoth.

Hwang Woo Su successfully cloned Snuppy in 2005

The scientist recently signed an accord to that effect with a university in Russia's Sakha Republic.

Vast areas of the republic are covered in permafrost that has begun to thaw over the years due to climate change, uncovering the well-preserved remains of several mammoths that had lain frozen in the ice for more than 10.000 years.

To clone new life from the remains, Hwang needs an intact cell nucleus that he hopes could contain the animal's entire genetic information. The scientist would then have to replace the nuclei of egg cells from a related species - in this case an Indian elephant - with those taken from the mammoth's cells.

It is possible - in principle. Three years ago, as part of a mammoth cloning project in Japan, researchers there managed to clone a mouse from the cells of a rodent that had been frozen for 16 years. Nothing has been heard of this project since then.

Fragmented DNA

Alex Greenwood, a biologist at the Leibniz Institute for Zoo and Wildlife Research (IZW) in Berlin, is skeptical about the mammoth-cloning project. A first look into the microscope may give scientists reason for hope because they can discern contours of cells and even cell nuclei in the mammoth tissue. But the structures are not intact, Greenwood said, "They are frozen imprints of ancient cells."

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Controversial scientist plans to clone a mammoth

Because everyones immune system is different, its impossible to predict with absolute certainty how any given person will react to a specific medication. In the not-too-distant future, however, at-risk patients may get their own custom-altered mouse, with an immune system thats a copy of their own. Medications could be tried out on the mouse first, and if it showed no adverse reactions, then the person could receive them. If the person had an autoimmune disease, the mouse could also provide valuable insight into its treatment. A team led by Columbia University Medical Centers Dr. Megan Sykes has recently developed a method of creating just such a personalized immune mouse.

The process begins by transplanting bone marrow stem cells from the human subject, along with a one-cubic-millimeter chunk of their thymus tissue, into a mouse with a disabled immune system. The thymus is an organ in the immune system, and the sample of it is implanted in the mouses kidney capsule, which is a thin membrane surrounding the kidney.

It incubates there for six to eight weeks, within which time it becomes seeded with the stem cells, which have been circulating in the mouses bloodstream. This in turn causes it to create a number of types of human immune cells, resulting in a robust and diverse human immune system matching that of the donor. Previous efforts have reportedly not been successful in creating a complete system, or have been hampered by the mice rejecting the human material.

Besides being used to test responses to medications, the personalized immune mice might also play a key role in developing individualized immunotherapies. These would allow patients to more successfully fight infections or cancer, or to accept transplanted tissue.

Additionally, Dr. Sykes plans on using the mice for research into type 1 diabetes, to determine how diabetic patients immune systems are different from those of non-diabetics, before the disease develops.

A paper on the research was recently published in the journal Science Translational Medicine.

Source: Columbia University Medical Center

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Peoples' immune systems can now be duplicated in mice

WASHINGTON (AP) -- Shares of Cytori Therapeutics Inc. jumped more than 10 percent Friday after the medical device maker said it received U.S. approval for a new version of its Puregraft system, which is used in cosmetic surgery.

Plastic surgeons use the device in fat grafting procedures that take fat from one part of the body and inject it into another. The device removes unwanted fluid, blood cells and debris from the fat and prepares it for grafting. Many procedures use fat from the thighs and abdomen to augment the breasts or face, aiming for a smoother, firmer look.

The latest version of the device can process 850 milligrams of fat, more than three times as much as the original Puregraft system approved in 2010. Plastic surgeons performed nearly 60,000 fat grafting procedures in the U.S. in 2010, according to industry figures

Shares of San Diego, Calif.-based Cytori rose 30 cents, or 10.6 percent, to close at $3.13.

Cytori has attracted attention from analysts for another device, called the Celution system, which some plastic surgeons have reportedly used to create fat grafts enhanced with adult stem cells. The device supposedly separates and purifies adult stem cells, which can then be mixed with fat grafts. Plastic surgeons in Los Angeles, Miami and elsewhere claim the so-called "stem cell facelift" creates a younger, healthier-looking physique than the incisions and implants associated with traditional surgery. But there are few studies to support such claims, and the Food and Drug Administration has not approved any therapies using stem cells for cosmetic use.

Early this year the two largest professional societies for plastic surgeons issued a joint statement calling on their members to avoid stem cell procedures. A review of the medical literature found little human data to support the benefits of injecting stem cells into patients, according to the statement from the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery.

"The marketing and promotion of stem cell procedures in aesthetic surgery is not adequately supported by clinical evidence at this time," reads the joint statement, published in January.

"This is modern-day snake oil," said Dr. Felmont Eaves, president of the American Society of Plastic Surgeons, in an interview last year with the Associated Press. "It is the worst form of merchandising for a procedure that doesn't have scientific evidence to back it up."

Eaves pointed out that surgeons have been using fat grafts to plump up cheeks and breasts for decades. The practice has a mixed record of success, and has never eclipsed the more popular facelift and breast implant procedures.

"There's no evidence that going the extra step to create a stem cell version of this makes any difference," Eaves said.

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Cytori rises on FDA clearance for fat graft device

A NEW stem cell therapy treatment to develop new bones for patients with bone loss and new skin for recipients of plastic surgery has been developed, doctors from Shanghai No.9 People's Hospital announced yesterday.

In the procedure, medical staff use a special machine to collect stem cells from a patient's blood. The stem cells adhere to a base made of a special biological material.

The stem cells are then transplanted into the patient's body, where they grow into either new bones or skin tissue, while the base is absorbed by the human body.

"So far the practice has been successful in treating patients with bone and skin loss," said Dr Dai Kerong from Shanghai Jiao Tong University's translational medicine institute at Shanghai No.9 hospital. "The stem cell technology will be used to develop corneas for blind people as well as treating heart attack and stroke patients by developing new heart and cerebral tissue."

The technology is patented in China and abroad and will be licensed within one or two years, according to Dai.

China has established 51 translational medicine centers to boost the introduction of laboratory research into clinical use.

The complicated procedures and documentation required often prevent doctors from introducing lab success into clinical practice.

Dai said one reagent developed by No. 9 hospital's doctors for in vitro fertilization received a license in Europe within six months and has been used in clinical practice "while this would take at least five years in China."

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Eastday-Big stem cell breakthrough

14-03-2012 13:25 Could synthetic stem cells mean the end of certain forms of blindness? Scientists at the University of Wisconsin have created basic retina structures, giving hope to many with eye damage that their vision could be repaired someday. The retina structures were created by synthesizing stem cells from a patient's blood, and successfully sent important information to the brain that helps humans see. Scientists can create the stem cells from a simple blood test, and the ability to build the retina structures from the cells—and isolate which layers need repair—will allow researchers to further study degenerative diseases like retinitis pigmentosa. The study is still in its primordial phases, but it could lead to some big leaps forward in research and maybe even some day the ability to generate new cells for patients whose eyes are going bad. Just think: Someday grandma may stop asking you where she put her reading glasses!

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Scientists Make Big Leap in Eye Research by Growing Retina Structures - Video

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law.

In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.

"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."

An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.

Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients.

Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back surgery in July.

The plan by Celltex and Perry to make Texas a leader in the therapy have been controversial since details about the governor's procedure became known last summer. The therapy, drawing on the ability of adult stem cells to replenish dying cells, is promising but thought by most medical researchers to need much more clinical study before it is commercialized.

Stem cells are a kind of medicine known as biologics, therapy involving living cells rather than chemicals. Most medical experts say that adult stem-cell therapy involves more than the "minimal manipulation" the agency allows without its oversight because the cells are isolated, cultured in a laboratory and stored for some period of time before being reinjected.

The FDA has recently stepped up enforcement of unregulated adult stem cell activity, though legal experts interviewed last fall by the Chronicle said it was unclear whether the agency would look into Perry's procedure because he seemed fully informed and unharmed by it.

The Texas Medical Board is currently considering a policy that would require providers of stem cells and other experimental drugs to use them only with the permission of independent review committees that assess trials for patient safety. The policy comes up for final approval in April.

See the article here:
Gov. Perry's stem-cell firm draws FDA scrutiny

Todd Finkelmeyer has been covering higher education for the Capital Times since April 2008. He started contributing to the newspaper in 1990, was hired full-time in 1994 and has since covered everything from the Super Bowl to stem cell research. Follow his Campus Connection blog for the latest on higher education news in the Madison area.

Researchers working on the University of Wisconsin-Madison campus have found a way to use neurons derived from human embryonic stem cells to restore muscle coordination in mice inflicted with a Huntingtons disease-like condition.

The findings, which were reported Thursday in the journal Cell Stem Cell by a team of scientists who work at the university's Waisman Center, could one day help lead to new therapies for Huntington's disease, the debilitating disorder that affects both muscle coordination and cognitive ability. There currently are no effective treatments.

This is very exciting, and next well try to move onto different models, particularly in primates, to see whether this actually works in a larger brain, says Su-Chun Zhang, a UW-Madison neuroscientist and the senior author of the study.

Zhang, who specializes in producing different types of brain cells from stem cells, explains that this particular research focused on GABA neurons -- the cells that deteriorate and thus disrupt the brains circuitry that leads to the loss of motor function in patients with Huntington's. He notes the GABA neurons make a chemical that plays an important role in helping to link the communication network in the brain with movement.

Zhang and co-workers in the lab figured out how to produce large amounts of these GABA neurons from human embryonic stem cells, which they tested in mice with a Huntingtons-like ailment. Initially, the researchers were just trying to see whether or not these cells could safely integrate into the mouse brain. They were stunned to see that the cells not only successfully merged into the brain, but that they also eventually sent signals to the proper targets and rewired broken circuitry to restore motor functions.

This was quite surprising, says Zhang. These human neurons actually projected a long distance to another place in the brain and hooked up at the circuit, which is essential for our movement coordination. This is very critical, because in order for cell therapies to work for Huntingtons, the circuit has to be re-formed.

He notes scientists generally didnt believe it was possible for this circuitry to be rewired in older brains. In the mature brain, the nerve cells do not project a long distance, particularly into the correct target, Zhang explains. But that happened with these cells. So the point is, these stem cells somehow know where to go.

Its not clear how relevant this information will be in finding treatments for Huntingtons, but the UW-Madison scientists are hopeful their research can be used as another building block of information that can one day lead to treatments for the debilitating disease.

According to the Huntington's Disease Society of America, more than a quarter of a million Americans have the ailment or are at risk of inheriting the disease from an affected parent.

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Campus Connection: UW research hints at potential for Huntington’s treatment

Washington, Mar 16 (ANI): A special type of brain cell forged from stem cells could help restore the muscle coordination deficits that cause the uncontrollable spasms characteristic of Huntington's disease, a new study has suggested.

Huntington's disease, the debilitating congenital neurological disorder that progressively robs patients of muscle coordination and cognitive ability, is a condition without effective treatment, a slow death sentence.

"This is really something unexpected," said Su-Chun Zhang, a University of Wisconsin-Madison neuroscientist and the senior author of the new study, which showed that locomotion could be restored in mice with a Huntington's-like condition.

Zhang is an expert at making different types of brain cells from human embryonic or induced pluripotent stem cells.

In the new study, his group focused on what are known as GABA neurons, cells whose degradation is responsible for disruption of a key neural circuit and loss of motor function in Huntington's patients.

GABA neurons, Zhang explained, produce a key neurotransmitter, a chemical that helps underpin the communication network in the brain that coordinates movement.

In the laboratory, Zhang and his colleagues at the UW-Madison Waisman Center have learned how to make large amounts of GABA neurons from human embryonic stem cells, which they sought to test in a mouse model of Huntington's disease.

The goal of the study, Zhang noted, was simply to see if the cells would safely integrate into the mouse brain.

To their astonishment, the cells not only integrated but also project to the right target and effectively re-established the broken communication network, restoring motor function.

The results of the study were surprising, Zhang explained, because GABA neurons reside in one part of the brain, the basal ganglia, which plays a key role in voluntary motor coordination.

Excerpt from:
'Forged' brain cells offers hope for Huntington's disease treatment

Newswise PHILADELPHIA Researchers at the Kimmel Cancer Center at Jefferson have demonstrated for the first time that the metabolic biomarker MCT4 directly links clinical outcomes with a new model of tumor metabolism that has patients feeding their cancer cells. Their findings were published online March 15 in Cell Cycle.

To validate the prognostic value of the biomarker, a research team led by Agnieszka K. Witkiewicz, M.D., Associate Professor of Pathology, Anatomy and Cell Biology at Thomas Jefferson University, and Michael P. Lisanti, M.D., Ph.D., Professor and Chair of Stem Cell Biology and Regenerative Medicine at Jefferson, analyzed samples of patients with triple negative breast cancer, one of the most deadly of breast cancers, with fast-growing tumors that often affect younger women.

A retrospective analysis of over 180 women revealed that high levels of the biomarker MCT4, or monocarboxylate transporter 4, were strictly correlated with a loss of caveolin-1 (Cav-1), a known marker of early tumor recurrence and metastasis in several cancers, including prostate and breast.

The whole idea is that MCT4 is a metabolic marker for a new model of tumor metabolism and that patients with this type of metabolism are feeding their cancer cells. It is lethal and resistant to current therapy, Dr. Lisanti said. The importance of this discovery is that MCT4, for the first time, directly links clinical outcome with tumor metabolism, allowing us to develop new more effective anti-cancer drugs.

Analyzing the human breast cancer samples, the team found that women with high levels of stromal MCT4 and a loss of stromal Cav-1 had poorer overall survival, consistent with a higher risk for recurrence and metastasis, and treatment failure.

Applying to a Triple Threat Today, no such markers are applied in care of triple negative breast cancer, and as a result, patients are all treated the same. Identifying patients who are at high risk of failing standard chemotherapy and poorer outcomes could help direct them sooner to clinical trials exploring new treatments, which could ultimately improve survival.

The idea is to combine these two biomarkers, and stratify this patient population to provide better personalized cancer care, said Dr. Witkiewicz

The findings suggest that when used in conjunction with the stromal Cav-1 biomarker, which the authors point out has been independently validated by six other groups worldwide, MCT4 can further stratify the intermediate-risk group into high and low risk.

Since MCT4 is a new druggable target, researchers also suggest that MCT4 inhibitors should be developed for treatment of aggressive breast cancers, and possibly other types. Targeting patients with an MCT4 inhibitor, or even simple antioxidants, may help treat high-risk patients, who otherwise may not respond positively to conventional treatment, the researchers suggest.

Paradigm Shift But the work stems beyond triple negative breast cancer, challenging an 85-year-old theory about cancer growth and progression.

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Cancer Paradigm Shift: Biomarker Links Clinical Outcome with New Model of Lethal Tumor Metabolism

OTTAWA A team of Canadian researchers has been awarded $442,000 to test the world's first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream that's notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospital's sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the body's hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

"It's a unique feature of the stem cells," said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. "Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system."

As with other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Canadian researchers receive grant to test stem-cell therapy for septic shock

13-03-2012 16:42 Hear Dr. Bowen talk about the exciting field of Regenerative Medicine. The type of regenerative medicine Dr. Bowen practices uses our own adult stem cells to achieve desired results.

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Cosmetic Regenerative Medicine - Video

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Su-Chun Zhang zhang@waisman.wisc.edu 608-265-2543 University of Wisconsin-Madison

MADISON -- Huntington's disease, the debilitating congenital neurological disorder that progressively robs patients of muscle coordination and cognitive ability, is a condition without effective treatment, a slow death sentence.

But if researchers can build on new research reported this week (March 15, 2012) in the journal Cell Stem Cell, a special type of brain cell forged from stem cells could help restore the muscle coordination deficits that cause the uncontrollable spasms characteristic of the disease.

"This is really something unexpected," says Su-Chun Zhang, a University of Wisconsin-Madison neuroscientist and the senior author of the new study, which showed that locomotion could be restored in mice with a Huntington's-like condition.

Zhang is an expert at making different types of brain cells from human embryonic or induced pluripotent stem cells. In the new study, his group focused on what are known as GABA neurons, cells whose degradation is responsible for disruption of a key neural circuit and loss of motor function in Huntington's patients. GABA neurons, Zhang explains, produce a key neurotransmitter, a chemical that helps underpin the communication network in the brain that coordinates movement.

In the laboratory, Zhang and his colleagues at the UW-Madison Waisman Center have learned how to make large amounts of GABA neurons from human embryonic stem cells, which they sought to test in a mouse model of Huntington's disease. The goal of the study, Zhang notes, was simply to see if the cells would safely integrate into the mouse brain. To their astonishment, the cells not only integrated but also project to the right target and effectively reestablished the broken communication network, restoring motor function.

The results of the study were surprising, Zhang explains, because GABA neurons reside in one part of the brain, the basal ganglia, which plays a key role in voluntary motor coordination. But the GABA neurons exert their influence at a distance on cells in the midbrain through the circuit fueled by the GABA neuron chemical neurotransmitter.

"This circuitry is essential for motor coordination," Zhang says, "and it is what is broken in Huntington patients. The GABA neurons exert their influence at a distance through this circuit. Their cell targets are far away."

That the transplanted cells could effectively reestablish the circuit was completely unexpected: "Many in the field feel that successful cell transplants would be impossible because it would require rebuilding the circuitry. But what we've shown is that the GABA neurons can remake the circuitry and produce the right neurotransmitter."

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Stem cells hint at potential treatment for Huntington's Disease

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law.

In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year.

"It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells."

An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously.

Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients.

Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back surgery in July.

The plan by Celltex and Perry to make Texas a leader in the therapy have been controversial since details about the governor's procedure became known last summer. The therapy, drawing on the ability of adult stem cells to replenish dying cells, is promising but thought by most medical researchers to need much more clinical study before it is commercialized.

Stem cells are a kind of medicine known as biologics, therapy involving living cells rather than chemicals. Most medical experts say that adult stem-cell therapy involves more than the "minimal manipulation" the agency allows without its oversight because the cells are isolated, cultured in a laboratory and stored for some period of time before being reinjected.

The FDA has recently stepped up enforcement of unregulated adult stem cell activity, though legal experts interviewed last fall by the Chronicle said it was unclear whether the agency would look into Perry's procedure because he seemed fully informed and unharmed by it.

The Texas Medical Board is currently considering a policy that would require providers of stem cells and other experimental drugs to use them only with the permission of independent review committees that assess trials for patient safety. The policy comes up for final approval in April.

The rest is here:
FDA receives complaint about Houston company that stored Gov. Perry's stem cells

Sergei Karpukhin / Reuters

A boy looks at the skeleton of a mammoth in the Ice Age Museum in Moscow.

Good news for anyone who wishes we could revert to prehistoric times, or really, anyone who thinks woolly mammoths are awesome. Scientists in Asia have announced plans to recreate the giant creature that stomped around the Earth some 4,500 years ago.

On Tuesday, scientist Hwang Woo-suk of South KoreasSooam Biotech Research Foundation signed an agreement with Vasily Vasiliev of RussiasNorth-Eastern Federal University to clone a mammoth, AFP reports.

(MORE: Japanese Scientist Says Well Have Mammoths by 2015)

Hwang, once lauded as a pioneer in the field of cloning, lost a bit of credibility in 2006 when some of his breakthrough human stem cell research turned out to be fabricated. However, experts have verified his work in creating the worlds first cloned dog, Snuppy, in 2005. Hwangs next goal could also come to fruition now that portions of Siberias permafrost have thawed and left behind mammoth remains. Sooam officials said the foundation will launch research this year.

So how exactly does one go about cloning a woolly mammoth? The scientists plan to replace the nuclei of elephant egg cells with those of a mammoth, producing embryos with mammoth DNA. Then, those embryos will be planted into the wombs of elephants for delivery. The mammoth cells would come from internal organs, skin, bones and blood. Finding well-preserved tissue with an undamaged gene will be the most difficult task, the researchers told the AFP.

Though the initiative is quite ambitious, the researchers said theyre confident, given their previous success in cloning animals and the success of their colleagues. South Korean scientists have already cloned animals including a cat, dogs, a pig, a cow and a wolf.

MORE: Free Woolly Out of the Cold

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The Woolly Mammoth's Return? Scientists Plan to Clone Extinct Creature

Hendrik Poinar, a scientist who believes he is close to cracking the woolly mammoth's genetic code, says that cloning extinct species is now possible. NBC's Jim Maceda reports.

By Alan Boyle

Russian and South Korean scientists, including the cloning expert who was the focus of a stem-cell scandal six years ago, have signed a deal to try re-creating a woolly mammoth using cells recovered from 10,000-year-old frozen remains.

The papers for the joint research project were signed on Tuesday by Hwang Woo-Suk, chief technology officer for South Korea's Sooam Biotech Research Foundation; and Vasily Vasiliev, vice director of Russia's North-Eastern Federal University, during a ceremony at Hwang's office in Seoul.

Hwang is infamous for his role in human embryonic stem-cell research: In 2004 and 2005, he and his colleagues claimed to have extracted stem cells from what they characterized as the world's first cloned human embryos. But in late 2005, his work was found to have been based on fabricated data, and he was barred from continuing research with human cells.

Despite the disgrace, Hwang continued working with animal cloning techniques. Before the scandal broke, his team announced that they produced the world's first cloned dog, nicknamed Snuppy, and that claim has stood up to scrutiny. Last October, Hwang's team at Sooam unveiled eight cloned coyotes that had been produced by injecting nuclei from coyote skin cells into dog eggs. At the time, he said he was interested in cloning an endangered African dog species known as the lycaon ... and was interested in cloning a mammoth, too.

In December, Japanese news media said that scientists recovered a seemingly viable sample of bone marrow from a frozen mammoth thigh bone in Russia's Sakha Republic, and that a mammoth could be cloned back from extinction within five years. This week, Agence France-Presse reported that North-Eastern Federal University is working with the Japanese scientists and with the Koreans. The Beijing Genomics Institute is said to be taking part in the Korean-Russian project as well.

Reports from Seoul suggest that the mammoth-cloning effort could be launched this year if the Russians can ship the remains to Sooam's laboratory. "The first and hardest mission is to restore mammoth cells," a colleague of Hwang's at Sooam, Hwang In-Sung, told AFP.

Jung Yeon-Je / AFP - Getty Images

South Korean scientist Hwang Woo-Suk, (far left) and Vasily Vasiliev, vice director of North-Eastern Federal University of Russia's Sakha Republic (far right), exchange agreements during a signing ceremony on joint research at Hwang's office in Seoul on Tuesday.

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Disgraced scientist leads mammoth-cloning effort

New route of administration provides greater convenience and choice for physicians and patients

TORONTO, March 15, 2012 /CNW/ - Janssen Inc. announced today that Health Canada has approved an expanded indication for VELCADE (bortezomib) to include subcutaneous administration in the treatment of multiple myeloma, a form of blood cancer.1,2 This route of administration was studied in patients with relapsed multiple myeloma. With this approval, Canadians living with multiple myeloma can now receive a convenient, subcutaneous (under the skin) injection that allows for greater physician and patient treatment choice.3 VELCADE was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of multiple myeloma patients who have relapsed following front-line therapy and are refractory to their most recent therapy. In 2008, VELCADE was also approved as part of combination therapy for the treatment of patients with previously untreated multiple myeloma who are unsuitable for stem cell transplantation.

"The new option of the subcutaneous delivery route has the potential for more patients to benefit from bortezomib. Patients with poor venous access will have improved convenience. For patients with pre-existing peripheral neuropathy and patients at high risk for developing peripheral neuropathy this alternate route will also result in improved safety with the reduced risk of developing worsening of neuropathy," said Dr. Kevin Song, MD, FRCPC, BC Cancer Agency, Vancouver General Hospital and the Leukemia/Bone Marrow Transplant Program of BC, Vancouver. "In addition, subcutaneous delivery of bortezomib provides physicians and patients the opportunity to tailor treatment based on individual preferences and circumstances. I have no doubt that the subcutaneous delivery route will become the preferred option."

Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow.4 Symptoms of the disease often include bone pain, fatigue, unusual bleeding (usually from the nose and gums), frequent infections and fevers, thirst, weight loss and nausea or vomiting. Multiple myeloma may also cause structural bone damage resulting in painful fractures.5 The goal of multiple myeloma treatment is to relieve symptoms, avoid complications, and prolong life.6

"Myeloma Canada endorses Health Canada's decision to approve the subcutaneous administration of VELCADE," said Aldo Del Col, Co-Founder and Executive Director of Myeloma Canada. "From a patient perspective, subcutaneous administration may reduce the risk of neuropathy, thereby allowing patients to continue their treatment to optimize clinical outcomes."

The results of an open-label, randomized, phase III non-inferiority study1 conducted with 222 patients with relapsed multiple myeloma randomly assigned to receive subcutaneous or intravenous bortezomib found that patients receiving bortezomib subcutaneously achieved a four-cycle overall response (ORR) of 42 per cent and complete response (CR) rate of six per cent, while patients receiving bortezomib intravenously achieved an ORR of 44 per cent and a CR rate of nine per cent. The overall safety profile was similar between the two arms. However, differences were observed in the incidence of peripheral neuropathy (PN). In the subcutaneous arm of the trial, six per cent of patients experienced PN of grade three or higher, compared with 16 per cent in the intravenous arm. In the subcutaneous arm, 38 per cent of patients experienced PN of all grades, compared with 53 per cent of patients in the intravenous arm. Dose reductions occurred due to drug related adverse events in 31 per cent of patients in the subcutaneous treatment group compared with 43 per cent of the intravenously treated patients.7 In the subcutaneous treatment group, 18 per cent of patients discontinued study treatment due to a drug-related adverse event compared with 23 per cent in the intravenous treatment group.8

"This new indication further supports the efficacy of bortezomib for patients living with multiple myeloma," added Dr. Song. "In addition, subcutaneous delivery may offer greater convenience to patients and healthcare providers."

About Multiple Myeloma in Canada Multiple myeloma is the second most prevalent blood cancer after non-Hodgkin's lymphoma.9 In 2011, there were approximately 7,000 Canadians living with multiple myeloma and the prevalence in Canada continues to rise.1 According to the 2011 Canadian Cancer Statistics report released by the Canadian Cancer Society, the total new cases of multiple myeloma diagnosed annually in Canada are estimated at 2,300, with the total number of deaths from multiple myeloma estimated at 1,370 annually.8 The average age at diagnosis is 62 years for men and 61 years for women, and only four per cent of cases are diagnosed in individuals under the age of 45.11

About VELCADE(bortezomib) for Injection1 VELCADE offers a completely novel approach to treating multiple myeloma by acting on a unique target in cells called the proteasome. By blocking the proteasome, VELCADE disrupts processes related to the growth and survival of cancer cells. The proteasome is a structure that exists in all cells and plays an important role in breaking down proteins that control how the cell lives and grows.

VELCADE was first approved in Canada under a Notice of Compliance with Conditions in January 2005 for the treatment of patients with multiple myeloma who have relapsed following front-line therapy and are refractory to their most recent therapy.

Excerpt from:
Health Canada approves subcutaneous administration of VELCADE®* in multiple myeloma

SUNRISE, Fla., March 15, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that it has successfully conducted a laboratory training course in partnership with the Ageless Regenerative Institute, an organization dedicated to the standardization of cell regenerative medicine. The attendees participated in hands on, in depth training in laboratory practices in stem cell science.

"We had students from all over the world attend this first course including physicians, laboratory technicians and students," said Mike Tomas, Bioheart's President and CEO. "Bioheart is pleased to be able to share our 13 years of experience in stem cell research and help expand this growing life science field."

The course included cell culture techniques and quality control testing such as flow cytometry and gram stain. In addition, participants learned how to work in a cleanroom operating according to FDA cGMP standards, regulations used in the manufacture of pharmaceuticals, food and medical devices. Aseptic techniques were also taught as well as cleanroom gowning, environmental monitoring and maintenance.

Future courses are open to physicians, laboratory technicians and students. After graduating the course, attendees are prepared to pursue research and careers in the field of stem cells and regenerative medicine. For more information about the course, contact info@agelessregen.com.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com.

About Ageless Regenerative Institute, LLC

The Ageless Regenerative Institute (ARI) is an organization dedicated to the standardization of cell regenerative medicine. The Institute promotes the development of evidence-based standards of excellence in the therapeutic use of adipose-derived stem cells through education, advocacy, and research. ARI has a highly experienced management team with experience in setting up full scale cGMP stem cell manufacturing facilities, stem cell product development & enhancement, developing point-of-care cell production systems, developing culture expanded stem cell production systems, FDA compliance, directing clinical & preclinical studies with multiple cell types for multiple indications, and more. ARI has successfully treated hundreds of patients utilizing these cellular therapies demonstrating both safety and efficacy. For more information about regenerative medicine please visit http://www.agelessregen.com.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

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Bioheart and Ageless Partner to Advance Stem Cell Field With Laboratory Training Programs

Newswise New York, NY (March 14, 2012) Columbia University Medical Center (CUMC) scientists have developed a way to recreate an individuals immune system in a mouse. The personalized immune mouse offers researchers an unprecedented tool for individualized analysis of abnormalities that contribute to type 1 diabetes and other autoimmune diseases, starting at the onset of disease. The findings were published today in the online edition of Science Translational Medicine.

The mouse model could also have clinical applications, such as predicting how a particular patient might respond to existing drugs or immunotherapies, reports senior author Megan Sykes, Michael J. Friedlander Professor of Medicine and Professor of Microbiology & Immunology and Surgical Sciences (in Surgery) at CUMC. Dr. Sykes is also Director for the Columbia Center for Translational Immunology. In addition, the model might prove useful for developing individualized immunotherapies for fighting infection or cancer or for lessening a patients rejection of transplanted tissue.

Researchers have been searching for new ways to tease apart the various factors that contribute to autoimmune disease. While large-scale studies of human populations have provided important clues to the genetic basis of immune diseases, they have offered little information about the specific role the genes play, says Dr. Sykes. Its difficult to isolate these mechanisms when looking at groups of patients who have had disease for different lengths of time or have been receiving different treatments. And the fact that they already have the disease makes it difficult to distinguish what underlies and propagates the autoimmune process.

Several research groups have attempted to create a personalized immune mouse. However, each model has had significant limitations, such as an inability to generate the full complement of immune cells and incompatibilities between tissues used to recreate the human immune system, leading to graft-versus-host disease.

Dr. Sykes model, in contrast, is able to recreate a robust and diverse human immune system, including T cells, B cells, and myeloid cells (which generate a variety of immune cells), free of immune incompatibilities.

The model is made by transplanting human bone marrow stem cells (also known as CD34+ cells), along with a small amount (approximately 1 cubic mm) of HLA-matched immature thymus tissue, into an immunodeficient mouse. (The HLA, or human leukocyte antigen, system mediates interactions among various immune cells.) The thymus tissue is implanted into the mouses kidney capsule, a thin membrane that envelops the kidney and serves as an incubator. Within six to eight weeks, the transplanted thymus tissue is seeded by circulating human CD34+ cells (which are infused into the mouses bloodstream), and begins generating human immune cells from the CD34+ cells.

A key to the models success was the teams discovery that freezing and thawing the transplanted thymus tissue, as well as administering antibodies against CD2 (a glycoprotein that mediates T cell development and activation), depletes mature T cells from the tissue graft. This prevents rejection of the human CD34+ cells and graft-versus-host disease, while preserving function of the thymus tissue.

Dr. Sykes intends to use the personalized immune mouse to study type 1 diabetes. We hope to find out what is fundamentally different about patients immune systems, compared with those of healthy individuals, before any disease develops, she says.

The studies should also reveal more about the genetics of type 1 diabetes. A number of HLA-associated genes have been linked to type 1 diabetes, she explains. About a third of the population has one of more of these genes. But a much smaller percentage of the population actually develops the disease. What this means is, the HLA genes are necessary, but not sufficient, to cause type 1 diabetes. Using the personalized immune mouse, we expect to learn more about the role that non-HLA genes play in the disease.

Dr. Sykes paper is entitled, A model for personalized in vivo analysis of human immune responsiveness. Her coauthors are Hannes Kalscheuer (Harvard Medical School, Boston, MA, and CUMC), Nichole Danzl (CUMC), Takashi Onoe (Harvard and CUMC), Ted Faust (Harvard and CUMC), Robert Winchester (CUMC), Robin Goland (CUMC), Ellen Greenberg (CUMC), Thomas R Spitzer (Harvard), David G. Savage (CUMC), Hiroyuki Tahara (CUMC), Goda Choi (CUMC), and Yong-Guang Yang (Harvard and CUMC).

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"Personalized Immune" Mouse Offers New Tool for Studying Autoimmune Diseases Model May Allow Development of ...