StemCell Therapy

Why Nebraska Orthopaedic and Sports Medicine?

Nebraska Orthopaedic & Sports Medicine has decades of experience providing the latest in orthopaedic procedures. We offer the entire range of treatments from conservative to surgical. The doctors at Nebraska Orthopaedic and Sports Medicine can help you choose the best treatment for YOU. Many clinics offering stem cell treatments for orthopaedic conditions are NOT orthopaedic doctors. When considering a clinic for stem cell treatment, you need to consider a doctors training and experience. Nebraska Orthopaedic & Sports Medicine is the only orthopaedic clinic in the region offering this exciting procedure.

Patients between the ages of18-64who have seen a physician for their condition and have exhausted all non-surgical measures (physical therapy, NSAIDs, cortisone injections, bracing, etc.) are ideal for Stem Cell Therapy

Shoulders, hips and knees will be the most common; however any joint or tendon can be treated using this procedure.

Because this is a newer treatment, the long-term outcomes are not fully understood and no guarantees can be made regarding outcomes.

Patients can expect to feel results over 1-3 months, although in some circumstances, relief may take as long as 6-9 months.

Because this is a newer treatment, the long-term outcomes are not fully understood and no guarantees can be made regarding outcomes.

Patients can expect to feel results over 1-3 months, although in some circumstances, relief may take as long as 6-9 months.

To schedule an appointment with Scott Swanson, MD, call (402) 488-3322. Dr. Swanson will assess you at an initial office visit to determine whether stem cell therapy is right for you.

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Stem Cell Therapy - Nebraska Orthopaedic and Sports Medicine

by Paul FassaHealth Impact News

Adult stem cell therapy is enjoying widespread success around the world, but if the FDA gets its way, it may soon be banned here in the U.S.

There have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions. It involves using the patients own stem cells, so no patent-able drugs are involved.

They are targetingthe most influential stem cell scientist in the U.S., Dr.Kristin Comella in Florida.

Many consider stem cell therapy the future of medicine. A stem cell can rebuild or create new cells in tissues, even in organ tissues other than those from which they had originally existed.

They could be considered seeds for growing body tissues. They are mostly able to function for cellular repair and growth no matter what organ is in need of repair or healing from chronic inflammation.

There is a considerable controversy surrounding stem cell therapy research, a branch ofregenerative medicine. Much of the controversy has to do with not differentiating between adult stem cell therapy and embryonic stem cell therapy.

Embryonic stem cell therapy is the controversial one. It cultures or creates stem cells from terminated or aborted fetuses.

Currently, the FDA is harassing stem cell clinics that do not derive their stem cell solutions from aborted fetus tissue. They extract the stem cells from the patients own adipose tissue and inject them into areas where that same patient needs repair. Its an autologous process called adult stem cell therapy.

U.S. Stem Cell based out of South Florida is one of the clinics being targeted by the FDA, and the clinics Chief Scientist isDr. Kristin Comella, PhD.

Many other nations have been using adult stem cell therapy successfully over the past 15 years, leaving the USA dead last in this field. The FDA is trying to make sure it stays that way and allows costly pharmaceutical versions to prevail.

Dr. Kristin Comellaand her clinichave been under attack from theFDA.

This short 3-minute video was produced interviewing Dr. Comella and some of her patients.

Human embryonic stem cell (hESC) therapy has received most of the medias attention and government support. But it is the most controversial because it involves extracting tissues from terminated human embryos, aka aborted fetuses.

In addition to moral and ethical issues, human embryonic stem cell (hESC) solutions create cells so rapidly where theyre injected they lead to cancerous tumors. To avoid that, researchers have to use immuno-suppressant drugs to curb the embryonic stem cells tendency toward cancer.

Using pharmaceutical drugs to curb hESC cancer side effect issues leads to other unexplored and unexpected side effects from those patented stem cell solutions.

But the profit motive for embryonic stem cell therapies was strong and a lot of government funds had been put into its research. Pharmaceutical companies were motivated because they could patent stem cells created from embryonic tissues.

Bone marrow stem cell therapy was among the first to depart from flawed hESC (human embryonic stem cell) therapies developed over the past two decades.Bone marrow stem cell therapy was the segue into the adult stem cell therapy movement.

Bone marrow extractions are painful, requiring general anesthesia. Its relatively difficult and expensive compared to adipose (fat) tissue stem cell harvesting.

Bone marrows high white blood cell count also encourages inflammation, making it counter-productive for patients already suffering from chronic inflammation or autoimmune disorders.

Most importantly, adipose (fat) tissue yields up to 500 times more mesenchymal stem cells than bone marrow sources, according to Dr. Comella. These are potent stem cells that can differentiate into a wide variety of other cell types. Furthermore, the adipose white blood cell count is lower than bone marrow matter.

Overactive, confused immune responses attack organs continually and create chronic inflammation and autoimmune diseases. The lower white blood cell count automatically lowers the risk of further inflammation among patients already suffering from chronic inflammation and autoimmune diseases.

The outpatient treatment involves creating a very small and shallow incision that wont require stitches on an area of skin covering adipose tissue (fat). From there, liposuction can withdraw a portion of the fat. This part of the procedure requires only a local anesthetic.

Then what is extracted is spun at high speed in a special centrifuge to isolate the stem cells which are then purified for IV drip delivery or injection into the same patient from whom it was extracted. Total costs range from five to ten thousand dollars or more in some cases.

Dr. Comella and her colleagues mission is to get adult stem cell therapy available for everyone. Private and government health insurance providers cover medical treatments that are much more expensive.

Why not cover one that would save money with its lower expense and fewer side effects?

Over the years, there have been nearly 12,000 adult stem cell therapies performed in the United States with an over 90 percent success healing rate for mostly joint and spinal conditions as well as heart and lung issues.

But the three known adverse side effect cases continually get all the media attention.

The Panama College of Cell Science, which helped launch Kristin Comellas research and development, had this to say about her:

Perhaps the most influential clinician on the subject of adult stem cell therapy, Dr. Comella has been able to quietly develop patient treatment protocols and treat patients via collaborating physicians and health care providers using legal patient-specific FDA guidelines, including studies permitted by Institutional Review Boards, patient-specific stem cell clinical trials, and direct treatments using the patients own stem cells that are harvested and re-injected for therapeutic purposes.

Through Dr. Comellas leadership, she and her team have trained and certifiedmore than 700 physicians worldwide in adult stem cell therapy. (Source)

The interview below allows the energetic Dr. Kristin Comella to give a thorough and upbeat description of adult stem cell therapy.

Since the late 1990s, adult stem cells used therapeutically were not under the control of the FDA and the adult stem cell movement took off.

There were complaints from some MDs that the adult stem cell practice should be regulated by the FDA. The Panama College of Cell Science responded to those outcries with this statement:

The motive in opposing adult stem cell therapy is money. The big institutions want to keep federal funding of embryonic stem cell research at a high level with the promise that cures are just around the corner despite the fact that embryonic stem cells will never be useful in any way for patient treatment because they immediately cause tumors when transplanted. (Source)

Adult stem cell therapy is an autologous treatment method. The stem cells are not lab-created. They are only isolated and purified after extracting them from the patient being treated. Injecting them back into that patient powers up the bodys own healing mechanism to overcome chronic ailments.

The FDA didnt and shouldnt have anything to do with regulating stem cells from ones own body. That situation has recently been arbitrarily and suddenly changed.

Around 2014, the FDA started tweaking their guidance rules for stem cell therapy with the purpose of getting new rules made into laws through Congress that could be interpreted according to FDA whims and enforced arbitrarily. Their agenda is to consider adult stem cells as FDA-regulated drugs.

During our phone conversation, Dr. Comella explained how the FDA ignored testimonies from adult stem cell practitioners during their 2015 public hearings regarding new guideline proposals. Then they arranged to create new rules behind closed door meetings that included pharmaceutical industry allies and insiders.

The result was that by 2017, the FDAs hands-off policy with adult stem cell therapy came to a sudden halt after years of highly successful stem cell practice.

By 2018, the FDA got nastier with the the most influential clinician on the subject of adult stem cell therapy as its target. The FDA started doing inspections of Dr. Comellas South Florida clinic that aredesigned for labs that manufacture drugs.

The standards for hospitals and clinics are not as strict as drug manufacturers. Those inspections were inappropriate for a clinic. But those inspectionsmade it easier to create damaging reports.

When the inspectors came by, they demanded to go into rooms while treatments were taking place with semi-nude or nude patients, which Dr. Comella prohibited. The inspectors also demanded to view patient medical records. She allowed that after redacting their names on the copies she gave them.

For her actions to protect patients privacy, inspectors allegedly cited Dr. Comella for resisting and obstructing FDA inspections.

Soon after the inspections, the FDA served Dr. Comella with a lawsuit for practicing medicine with unapproved drugs. The drugs were only those stem cell solutions drawn from patients to be used on them.

The FDA has allegedly offered to drop the lawsuit if Dr. Comella signed an agreement to stop doing adult stem cell therapy and no longer promote it.

She refused. She said she has witnessed people leave their wheelchairs for good from this therapy. The trial is set for a Federal Court hearing beginning June 2019, in Miami, Florida.

If Dr. Comella loses this court case, adult stem cell therapy in the USA may be forced out of the country and only be available to those who can affordmedical tourism.

Published on March 11, 2019

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FDA Wants to Shut Down Adult Stem Cell Therapy as its Healing ...

As first described in 1988 by Dr. Arnold Caplan, mesenchymal stem cells are progenitor cells that have the power to differentiate into mature tissue cells. They are directly responsible for healing damaged tissues after injury. Upon encountering damaged tissue, they release proteins that decrease inflammation and trigger growth of new connective tissues and blood vessels, stimulating tissue repair and regeneration. In the case of severe damage and cell death, these cells have the ability to turn into healthy versions of the damaged or destroyed cells that they encounter.

At Regenerative Orthopedics we take stem cells from your own bone marrow or from your own fat or both. Under sterile conditions, they are then washed, concentrated and isolated under direct supervision by Dr. Smith in our office laboratory. We combine these cells with platelet rich plasma isolated from your blood drawn at the same time we harvest your cells. This mixture is then injected into the affected area.

Every joint in the body and most tissues contain stem cells that are responsible for maintaining health in that location. Degeneration of tissues or joints occur when the stem cell population becomes depleted and that structure losses its ability to heal itself as a result of injury of the natural aging process. Stem cell therapy is an attempt to repopulate tissues or joints with stem cells thereby restoring the bodys ability to heal itself.

Upon establishing that you are a candidate for treatment, we will decide whether to harvest stem cells from your bone marrow or from your fat or both. We recommend most patients undergo a minor arthroscopic procedure just prior to the stem cell treatment called microfracture where small holes are made in the end of the affected bone. This is in effect a bone marrow harvest as it allows stem cells from the bone marrow to enter the joint. Because these are not concentrated, the second part of the procedure will consist of harvesting Adipose derived stem cells or in other words stromal vascular fraction and using these stem cells to augment the procedure by injecting them into the affected joint.

Adipose tissue consists of adipocytes (fat cells) and the stromal vascular fraction (SVF). The stomal vascular fraction which contains millions of unused stem cells is harvested through a process known as lipoaspiration. Lipoaspiration is performed under local anesthetic in the office using a small instrument slightly larger a hypodermic needle. About 60 ml of fat is aspirated during lipoaspiration which differs from liposuction in which volumes of up to 6 ,000 ml of fat is removed. Once the fat is obtained, the stromal vascular fraction is isolated in the lab through a process that involves washing the fat then mixing it with an enzyme that causes the stem cells to detach from the fat cells. Final isolation involves the use of a centrifuge for final separation of the cells. These cells are then mixed with PRP and isolated from the patients own blood. Prior to injection, the mixture is then activated using photo-modulation.

Bone marrow is rich in growth factors and stem cells. We are able to obtain these cells in the office under local anesthesia in a very simple procedure that requires a relatively small amount of bone marrow and only one puncture site. This is vastly different that harvesting bone marrow for transfusion for cancer therapies. This technique will be utilized in the event that the patient has minimal fat deposits from which to obtain stem cells. Unlike SVF, bone marrow stem cell aspiration is not concentrated and so the amount of stem cells that can be isolated from this technique decrease with increasing age. For most patients, their bone marrow will be utilized and accessed through microfracture as described above.

Because these therapies stimulate the normal growth and repair processes, they rarely provide immediate relief unlike steroid injections. However, the results are much longer lasting. Typically, it takes between two and eight weeks before patients notice significant improvement.

These treatments are intended to reverse tissue damage and degenerative changesbut they do not stop the natural aging process which starts again once the tissues have regenerated. Overall, these therapies should provide good relief of pain from two to six years after treatment. Patients will require repeat treatment throughout their life as they get older and joints continue to degenerate.

No. Although these treatments are done worldwide and have been proven an effective alternative for treatment of pain related to damage and degeneration of joints, they are still considered experimental and not covered by insurance plans. Payment is due at the time of service.

Maintain a regular exercise program that is not excessive. Eat well and get enough sleep. Avoid excessive alcohol drinking and no smoking. Dr. Smith will also recommend an appropriate vitamin supplement to optimize stem cell function.

Regenerative Orthopedics does not culture, manipulate or save your cells. The process we utilize to obtain your stem cells results in the harvesting of cells in the range of 2 to 4 million stems cells and so there is no need to manipulate or grow your cells in the lab.

We keep our office overhead down by maintaining a small office staff and a small but adequately sized office. We also keep advertising to a minimum because most of our patients are referred by other patients and word of mouth referrals. This allows us to pass our cost savings on to you the patients.

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Stem Cell Therapy | Regenerative Orthopedics Institute

Cardiac-Pulmonary Conditions

Led by Melvin M. Propis, M.D., South Florida Stem Cell Center is one of theleading Stem Cell Regenerative Therapy Clinics in South Florida. Dr. Propis is a seasoned M.D. and surgeon who has had solid success rates.

Stem Cell Regenerative Therapy is a breakthrough in medical science that treats and prevents conditions and diseases using stem cells. This is accomplished by harvesting cells and then concentrating those cells in a lab before precisely re-injecting them. This greatly increases your bodys own natural repair cells and promotes healing.

South Florida Stem Cell Center is made up of research scientists and experts in Stem Cell Therapy.Our passion and belief is that our treatments truly helpthose that are suffering and need our help.

Maribella MKnee Injury

I injured both of my knees. After confirming that the cartilage was still in the joint, Dr. Propis injected my knees with a mixture of stem cells and PRP 4 months ago. Today I walk comfortably, No pain in those joints. I have noticed significant improvement in my balance and no longer need a walker or narcotics for pain.

Mia HCrohn's Disease

I have had Crohns disease for most of my short life which has led me to miss out on many teenage activities. After seeing other patients improve from having stem cells injected, I (and my mother) decided to try it. It was a wonderful thing to gradually be able to discontinue giving myself Humara shots routinely. I can actually have an active social life without worrying and even married the love of my life last year. Thanking my doctor, mom, God, and the many people who believe in stem cells for my happy ending!

George BDiabetes

I flew to the US in hopes of getting help for my diabetes. Having tried medicine & diets with no results, I was ready to try stem cells. After 1 treatment (and a six month period) I am off all meds and not considered diabetic anymore. To me, life changing! Especially after a relatively simple procedure. Thank you to the office of Dr. Propis and staff.

We Specialize In Treating:

Immunological Conditions

A chronic inflammatory bowel disease that affects the lining of the digestive tract.

Widespread muscle pain and tenderness.

A chronic inflammatory disorder affecting many joints, including those in the hands and feet.

An inflammatory disease caused when the immune system attacks its own tissues.

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Neurological Conditions

A congenital disorder of movement, muscle tone, or posture.

Damage to the brain from interruption of its blood supply.

A progressive disease that destroys memory and other important mental functions.

A disease in which the immune system eats away at the protective covering of nerves.

A disorder of the central nervous system that affects movement, often including tremors.

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Degenerative Conditions

Damage to any part of the spinal cord or nerves at the end of the spinal canal.

A chronic condition that affects the way the body processes blood sugar (glucose).

Kidney Failure (Renal Failure)

A condition in which the kidneys lose the ability to remove waste and balance fluids.

A type of arthritis that occurs when flexible tissue at the ends of bones wears down.

Occurs when a man can't get or keep an erection firm enough for sexual intercourse.

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South Florida Stem Cell Center | Regenerative Therapy Clinic

Stem Cell Therapy Training Course & Procedure Kits by Apex

Stem cell therapy has some of the most exciting treatment potential in medicine today. Stem cells are the bodys master cells. They are undifferentiated cells which allow them to develop into other types of cells that are required to repair or replace damaged tissue. Stem cells can stimulate the formation of cartilage, tendon, ligaments, bone and fibrous connective tissues. Stem cells have been clinically and scientifically proven to effectively treat most chronic pain conditions, accelerate the healing, and reduce scarring.

A high volume of stem cells is obtained from the patients own bone marrow or fat tissue (adipose). Once the stem cells have been concentrated, they are injected into damaged areas of the body to promote regeneration and healing. These therapies are a safe, nonsurgical treatment option for most chronic pain conditions, wound care, and aesthetic abnormalities.

Not all stem cell therapy procedures or concentrating processes are the same. APEX Biologixs Stem Cell Concentration System offers the best processing technique to maximize patient outcomes. The APEX Biologix system creates a highly concentrated injectate of stem cells and growth factors.

With our system, we provide training videos, processing guides, and remote training if needed.

Regenerative medicine is a rapidly growing specialty, and with popular demand, more physicians are seeking a didactic learning environment where they can learn the science and practice performing these therapies.

APEX Biologix partners with the Advanced Regenerative Medicine Institute (ARMI) to host training seminars where highly qualified physicians and specialists in regenerative medicine provide the essential instruction and necessary hands-on training. The goal of these training courses is to educate physicians interested in regenerative medicine and help them implement these cutting-edge therapies into their practice.

APEX Biologix provides complimentary business and marketing support to physicians who want to begin offering regenerative therapies to their patients. APEX Biologix has helped several clinics nationwide implement these therapies into their practices. Some of these therapies have become the clinics highest revenue stream.

Learn about regenerative medicine and how to successfully incorporate regenerative medicine into your practice.

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Stem Cell Therapy Training Course & Procedure Kits by Apex

Your spine is a complex network of bones, tendons, ligaments, muscles, soft tissue, cartilage and nerves. So many things can go wrong with your back. But stem cell therapy for lumbar discs, herniated disc stem cell therapy and stem cell therapy for bulging discs can ease your pain and repair the damage. Additionally, you can get an injection of stem cells for disc regeneration.

If youre living a nightmare of everyday back pain, it may be time for regenerative medicine. Traditional treatments offer a limited number of options, ranging from medication to surgery.

While you can cover the pain and mask the symptoms with medications and injections or even undergo surgery and extensive rehab there are no guarantees that your pain will end. In many cases, pain management just becomes a part of your life. Stem cells for disc regeneration is fast becoming the go-to procedure if youve whove suffered from back injuries or chronic back pain.

A safe and proactive alternative to invasive procedures and narcotics is herniated disc stem cell therapy and other stem cell procedures that target back pain. Stem cell technology is changing the way people view chronic pain. Instead of having to cut or fuse your spine, your very own stem cells can be used to treat the source of your pan directly.

The process often can be done in as little as an hour or two in your local New York pain management doctors office. Dr. Leon Reyfman and his team have seen positive results with stem cells for disc regeneration. Theres no more reason to mask symptoms when stem cells and platelet rich plasma treatments are able to rebuild damaged or diseased discs in your spine.

Degenerative disc disease is the term commonly used when speaking about the effects of aging on your spine. As you age, the spinal discs that act as shock absorbing cushions between your vertebrae tend to break down or rupture altogether. These discs allow your spine to bend, twist and flex. As the discs become compromised, your range of motion is greatly affected and you experience varying amounts of pain.

Degenerative disc disease typically impacts discs of your neck (your cervical spine) or the discs of your lower back (your lumbar spine). If youre among the many people suffering with chronic pain in your lower back, theres a good chance youre experiencing some internal disruption of your lumbar discs. Degenerative disc disease in your lumbar region can potentially lead to far worse problems than simply back pain. Some of the resulting conditions are:

All of these conditions can put a lot of pressure on your spinal cord and spinal nerves, which compromises your nerve function and causes you pain. Stem cell therapy for lumbar discs has proven to be particularly effective at repairing degenerated discs. These minimally invasive injections are far superior to other therapies previously available for lumbar pain.

Stem cell therapy for bulging disc and injecting stem cells for herniated disc problems are growing in popularity. And while bulging and herniated discs are related to degenerative disc disease, they arent the same thing:

Since the difference between a bulging disc and a herniated disc is just a matter of degree, getting stem cells for herniated discs and bulging discs work in exactly the same fashion. Herniated disc stem cell therapy uses stem cells from your bone marrow and platelet rich plasma from your own blood. Both are safe, effective ways to treat damaged discs because they simply turbo-charge your bodys ability to heal itself.

Dont be discouraged if your discs arent the source of your back pain. Stem cell therapy is also being used to treat several other types of spinal conditions, including:

Back pain can be tricky. Even if youve been diagnosed with a bulging or herniated disc, your pain may actually be the result of problems with your spinal ligaments. This basically means youve sprained your back. Ligament instability is also treatable with stem cells and platelet rich plasma. Since the regenerative procedures rely on your own cells, theres little-to-no risk of rejection, and you can begin to feel relief very soon after a treatment.

Since stem cell therapy promotes your bodys natural healing, its not a quick fix. It takes time for you to heal enough to feel the difference the treatments are making. It could take two to three weeks after the injection to begin to notice results. The swelling in your spine could take a couple months to go down entirely. But you will feel significantly better by then.

For a lot of patients, a single round of stem cell therapy for lumbar discs or cervical discs is all thats needed to drastically reduce their back pain. Plus, you can expect these results to improve for the rest of your life. If youre suffering from a particularly aggressive degenerative condition, however, additional stem cell injections may be necessary.

While the future of using stem cell therapy for disc regeneration is exciting, non-surgical stem cell technology has been in practice since the 1990s. The science and methods have improved considerably. Now the entire procedure has been reduced to a matter of hours.

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Medical professionals debate whether or not stem cells therapy is an effective treatment for sports injuries, such as ACL tears and chronic tendonitis. It is a controversial subject and research is ongoing.

See Anterior Cruciate Ligament (ACL) Tears

The theories behind stem cell therapyResearchers theorize that when applied to a sports injury, stem cells might:

See Knee Cartilage Repair, Regeneration, and Replacement

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Future research will help show if none, all, or a combination of these processes is at work. In the meantime, doctors debate whether or not stem cells are a good treatment option for sports injuries.

The challenge facing researchersThere is no standard recipe for stem cell therapy. The stem cell therapy in one study is not necessarily the same as the stem cell therapy in another study. The differences can include:

Because of these differences, it is difficult for researchers to draw conclusions or make generalizations based on existing studies.

Many sports medicine doctors use stem cell therapy in combination with another regenerative medicine therapy, platelet rich plasma (PRP). These physicians believe that PRP can make the most of the stem cells potential effects.1,2

See Types of Regenerative Medicine for Sports Injuries

PRP is derived from a sample of the patients blood. In the bloodstream, platelets secrete substances called growth factors and other proteins that:

See Are PRP Injections Effective?

PRP can be used alone to treat sports injuries, such as elbow tendinopathy.

See What Is the Difference Between Tendonitis, Tendinosis, and Tendinopathy?

Like stem cell therapy, PRP therapy is a not a standard therapy and may not be covered by insurance.

See Pros and Cons of Using PRP for Tendon Injuries

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By NameArmaghani, Sheyan J, M.D.Baker, Christopher E., M.D.Barna, Steven A., M.D.Beatty, Ellen , M.D.Bernasek, Thomas L., M.D.Donohue, David M., M.D.Echols, Jr., Eddy L., M.D.Epting, Timothy C., D.O.Frankle, Mark A., M.D.Garcia, Michael J, M.D.Garlick, Grant G, M.D.Gasser, Seth I, M.D.Grayson, Christopher W, M.D.Gustke, Kenneth A, M.D.Hess, Alfred V., M.D.Infante, Jr., Anthony F, D.O.Jackson, Howard B, M.D.Lindbloom, Benjanmin J., M.D.Lyons, Steven T, M.D.Maxson, Benjamin J, D.O.Mighell, Mark A, M.D.Mir, Hassan R, M.D., M.B.A.Miranda, Michael A, D.O.Morse, Adam C, D.O.Nydick, Jason A, D.O.Palumbo, Brian T, M.D.Pappou, Ioannis P, M.D.Ramirez, Jr., John D., D.C.Reina, David A, D.C.Saatman, Donna A, M.D.Samad, Adil A, M.D.Sanders, Roy W., M.D.Sellman, Jeff E, M.D.Shah, Anjan R, M.D.Small, John M., M.D.Stone, Jeffrey D, M.D.Tresser, Steven J., M.D.Walling, Arthur K., M.D.Watson, David T., M.D.Weinstein, Marc A., M.D.Yi, Seung Jin, M.D.Zaffer, Syed M., M.D.

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Stem Cell Therapy | Florida Orthopaedic Institute

As long as providers use autologous stem cells (definition: stem cells that come from the patient themselves) for regenerative therapy, the FDA accepts these procedures as complying with current standards of care. The equipment that we use to process your stem cells is FDA cleared for that use. All placental, amniotic, and umbilical cord blood/tissue products must have product-specific approval from the FDA, and as of now none of the commercially and currently available products have that approval except in one instance, and that is when umbilical cord blood stem cells are used specifically and only to treat hematological diseases like leukemia. No amniotic, placental, or umbilical cord blood or tissue products are FDA approved for regenerative medicine, and providers that currently use these products have only a limited time left before the FDA mandates that they must stop or face stiff sanctions. At Dynamic Health we have always used the patients own stem cells, and until more effective treatments are discovered and approved by the FDA we will continue to do so.

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Stem Cell Therapy | Stem Cell Treatment | Charlotte, NC

Clinical research regarding stem cell therapy benefits has grown dramatically in recent decades. The most promising thing about stem cell therapy and similar prolotherapy treatments including PRP is that they offer relief for patients with chronic pain and difficult-to-heal injuries, all without medications or risky reconstructive surgeries. Today researchers are also uncovering ways to apply stem cell treatments for common chronic conditions such as heart disease,neurodegenerative diseases and diabetes.

The most common use of stem cell treatments in prolotherapy is managing pain. Most consider stem cell therapy to be a form of interventional pain-management, meaning its a minimally invasive technique. Treatment involves injecting stem cells (along with an anesthetic and sometimes other substances) around painful and damaged nerves, tendons, joints or muscle tissue.

What specific types of conditions can stem cell therapy help treat? Some of the most common include osteoarthritis knee pain, tennis elbow, shoulder pains or rotator cuff injuries, tendonitis, Achilles tendon injuries and now cardiovascular diseases likeatherosclerosis.

There are now more options available to patients than ever before for various types of prolotherapy treatments, but the type of prolotherapyI recommend the most is the unique approach to stem cell therapy offered by the Regenexxclinic. I have personally visited the Regenexx clinic in the Cayman Islands to receive treatments performed by Dr. Chris Centeno, Dr. John Schultz and Dr. John Pitt for back and tendon injuries. The form of stem cell therapy offered by these doctors is considered to be one of themost thoroughly researched and effective in the world.

Stem cell therapy is a type of treatment option that uses a patients own stem cells to help repair damaged tissue and repair injuries. Its usually performed relatively quickly through injections, and is a simple outpatient or in office procedure.

This type of treatment has also been found to help:

According to the National Institute of Health,

Stem cells are important for living organisms for many reasons. In the 3- to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lungs, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for other cells that are lost through normal wear and tear, injury, or disease.

The California Stem Cell Agency reports that there is no limit to the types of diseases that could be treated with stem cell research. Because of their amazing abilities to help with regrowth, stem cell therapy treatments are now being used (or continuously researched) in regards to treating:

Stem cells are usually taken from one of two areas in the patients body: bone marrow or adipose (fat) tissue in their upper thigh/abdomen. Because its common to remove stem cells from areas of stored body fat, some refer to stem cell therapy as Adipose Stem Cell Therapy in some cases. (1)

Once stem cells from removed from one of these locations, they are placed in a centrifuge machine that spins them very, very quickly and concentrates the substances that are most valuable (including up to seven different types of natural growth factors). The sample of concentrated stem cells is then injected directly into the patients affected, painful area allowing the cells growth factors to go to work immediately, building new skin cells, connective tissue and so on.

What exactly makes stem cells so beneficial and gives stem cell injections the power to do this healing? Stem cells have the following unique characteristics, uses and healing abilities:

The type of stem cells being used in the most cutting-edge orthopedic practices including those offered at the Regenexx clinic mentioned above are called Mesenchymal stem cells (MSCs). A growing body of research shows that MSCs have the capability of differentiating and forming new orthopedic tissues that make up muscle, bones, cartilage and tendons, ligaments and adipose tissue. (3)

Research suggests that in treating orthopedic problems,fat-derived MSCs tend to under-perform bone marrow derived stem cells, therefore bone derived is the preferred method. (4) This is especially true when bone marrow cells are dramatically concentrated using advanced centrifuge equipment. Certain studies have found that these advanced samples can contain up to 25 different growth factors and other beneficial rebuilding substances.

In studies regarding orthopedic care such as those used for cartilage replacement,bone repairand soft-tissue repair bone marrow stem cells injections have been found to: reduce chronic pain, heal stubborn injuries, improve functionality and return patients to their normal routine sometimes within just one week.

Wondering if MSCs for orthopedic injuries are safe? There is no evidence of overgrowth of MSCs in damaged tissue or reason to believe theres risk for tumor growth. Advanced clinics such as Regenexx actually count cells before injecting them and carefully monitor progress. According to research used by Regenexx, MSCs safely stop proliferating once they physically contact each other, because this signals to them that the affected area has reached its full potential in growth. (5)

Cardiovascular diseases can deprive heart tissue of oxygen and cause scar tissue to form which changes blood flow/blood pressure. Research suggests that stem cells taken from adult bone marrow have the ability to differentiate into those needed to repair the heart and blood vessels, thanks to the secretion of multiple growth factors. Several ways in which stem cell therapy is now being used and further researched in regards to improving recovery of heart disease are:

Although more research is needed to assess the safety and efficacy of this approach, stem cell types used in heart disease treatment include: embryonic stem (ES) cells, cardiac stem cells,myoblasts (muscle stem cells), adult bone marrow-derived cells, umbilical cord blood cells, mesenchymal cells (bone marrow-derived cells) and endothelial progenitor cells (these form the interior lining of blood vessels).

Studies have found that stem cell treatments can help improve the growth of healthy new skin tissue, improve collagen production, stimulate hair growth after loss or incisions, and help replace scar tissue with newly formed healthy tissue.

One of the ways stem cells help facilitate wound healing is by increasingcollagen concentrations in the skin, which shrinks as it matures and thereby strengthens and tightens the damaged area. This same mechanism also applies to treating connective tissue injuries related to collagen/cartilage loss, such as those caused by osteoarthritis or overuses that affect ligaments or tendons.

Recent progress in the treatment of diseases like Parkinsons, Huntingtons, Alzheimers and stroke recovery show that transplanted adult stem cells can be used to form new brain cells, neurons and synapses following cognitive degeneration or brain injuries. (6) Research conducted by the Research Center for Stem Cell Biology and Cell Therapy in Sweden is still underway, but current findings show that stem cells can improve synaptic circuits, optimize functional recovery, offer relief from degeneration symptoms, slow down disease progression and potentially even more.

Some of the ways that stem cell injections/grafts work in neurodegeneration treatment are: normalizing striatal dopamine release, impairing akensia (loss of voluntary movement), replacing neurons destroyed by the ischemic lesions following strokes and halting destruction of nigrostriatal dopaminergic neurons.

Immune rejection is the term used to describe damage to healthy tissue and cells in patients with autoimmune disorders and other inflammatory conditions. In people who suffer from type1 diabetes, for example, the cells of the pancreas that normally produce insulin are destroyed by the patients own immune system; in people with thyroid disorders, the thyroid gland is attacked and damaged.

Research continues to show us that certain adult stem cells are capable of differentiating and producing needed cells, such as insulin-producing cells that eventually could be used in with people diabetes. This strategy is still being researched extensively and is not yet widely available, as scientists continue to experiment with reliable strategies for generating new cells/tissues that will not be rejected or harm the patient once implanted.

Meanwhile, a promising clinical trial led by Dr. Richard Burt of Northwestern University that explores the potential benefits of stem cell therapy for multiple sclerosis is underway as of March 2018. The 110 patients participating either received a drug treatment or hematopoietic stem cell transplantation (HSCT).The clinical trial looks promising given that after one year of treatment only one relapse occurred among patients in the stem cell group compared with 39 relapses in the drug treatment. And, after about three years, the stem cell transplants had a 6 percent failure rate compared with a failure rate of 60 percent in the control (drug treatment) group.

The researchers note that stem cell therapy doesnt work for all cases of MS and its not an easy process. First patients must undergo chemotherapy to destroy their faulty immune system. Then stem cells that help make blood through a process called hematopoiesis are removed from the patients bone marrow and reinfused into the patients bloodstream. These fresh stem cells, which are not affected by MS, rebuild the patients immune system. Despite this challenging process, preliminary results demonstrate that this could be an effective treatment in the future. (7, 8)

For decades researchers and doctors primarily used two kinds of stem cells taken from animals and humans, especially when they were still embryos (not yet born). These are calledembryonic stem cells and non-embryonic (somatic or adult) stem cells. In the late 1990s, it was discovered that stem cells could be taken from human embryos and grown inside of laboratoriesfor reproductive purposes, including for in vitro fertilization.

Then in 2006 a breakthrough discovery was made that some specialized adult stem cells could be reprogrammed and used in many other ways to help repair damaged tissue. These are referred to as induced pluripotent stem cells (iPSCs) and are the type used in many of the treatments described above.There remains a lot to learn about the potential uses of stem cell therapies, and how scientists can continue to explore transforming unspecialized adult stem cells into the types of specialized cells needed.

The NIH reports that in future years some of the primary goals of stem cell therapy research are to: identify howundifferentiated stem cells become the differentiated cells that form the tissues and organs, determine how stem cells can turn humangenes on and off, learn to predictably control cell proliferation and differentiation, and investigate more uses for stem cells in serious medical conditions such as cancerand birth defects.

The hope going forward is that stem cells can also be used as a renewable source of replacement cells and tissues to treat common and serious diseases without the need for organ transplants or surgeries, including: maculardegeneration, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, rheumatoid arthritis and cancer.

Cancer treatment is a particular important area under investigation, as early studies are showing that stem cells are safe and well-tolerated in patients with acute and chronic leukemia, lymphoma, multiple myeloma and other cancers. (9)

Stem cell treatments are offered by various doctors who practice pain-management and other techniques, including orthopedics and anesthesiologists.Depending on the type of treatment needed, its also possible to visit a neurologist, cardiologist, etc.Commonly these treatments are offered at clinics with ateam of doctors who work together to specialize in diagnosing, preventing and/or correcting a range of musculoskeletal, neurological or connective tissue disorders/injuries.

If youre planning on visiting a doctor for pain management, look for a physician who has board certification through an organization like the American Board of Anesthesiology orAmerican Board of Pain Medicine. I recommend viewing this Physician Finder tool to locate a practitioner who performs the advanced type of stem cell applications described above.

Personally, I most suggest checking out Regenexx, one of the only organizations to run large-scale analysis of patient stem cell procedure outcome data. It has published numerous findings from tracking their own patients on their website. Much more detailed information on improvements that can be expected following PRP procedures including those for knee meniscus, arthritis, hip dysfunction, knee pain, wrist/hand injuries, ankle/foot pain and shoulder/rotator injuries can be accessed through Regenexx directly.

Once you find a qualified physician, heres a brief overview of what you can expect from stem cell therapy treatments:

Although stem cell treatment is considered to be very safe, there are also side effects that are possible. Make sure to find a qualified practitioner and let them know if your experience following a treatment does not sound like the typical one described above.Like other types of non-invasive treatments and prolotherapy techniques, some mild side effects after injections are normal. Side effects of stem cell treatments can sometimes include:

From the sound of it, you might think leaky gut only affects the digestive system,but in reality it can affect more. Because Leaky Gut is so common, and such an enigma,Im offering a free webinar on all things leaky gut.Click here to learn more about the webinar.

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5 Stem Cell Therapy Benefits, Uses & How It Works - Dr. Axe

DEAR MAYO CLINIC: Whats the latest information on using stem cell therapy to treat an arthritic shoulder that causes excessive pain?

ANSWER: New efforts in regenerative medicine, including stem cell therapy, could dramatically affect orthopedic surgery over the coming years. Much of this hope is pinned on using stem cells to treat degenerative conditions such as shoulder arthritis. Although it shows promise, stem cell treatment for arthritis isnt widely available at this time, as its still being researched.

Stem cells are the basic building blocks of all human tissue. Stem cells hold potential as treatment, in part, because they can communicate valuable information about tissue growth and healing to other cells in the body. Arthritis involves joint degeneration due to loss of the cartilage that cushions bones. Recently researchers have begun to look to stem cells for orthopedic conditions such as shoulder arthritis. Progress using stem cells to treat arthritis already has been reported, with the ultimate goal of using stem cells to regrow cartilage.

When discussing stem cell therapy, its important to understand that pure stem cells are not currently available to U.S. patients outside of a clinical research study. A handful of clinical research trials, monitored by the U.S. Food and Drug Administration (FDA), are ongoing at this time to study stem cell treatment for arthritis. The early findings from these trials are encouraging.

Unfortunately, the excitement surrounding emerging stem cell therapy has led some patients and health care providers to overlook the lack of scientific evidence to support its use at this time. Stem cell therapies currently used outside clinical studies do not contain pure stem cells. Instead, they are a mix of a variety of cells, of which only a very small percentage are stem cells. It is possible that many of these treatments do not contain enough stem cells to help.

It is also important to recognize that many stem cell therapies now marketed directly to patients are conducted without the required biologics license from the FDA. Also, some forms of mislabeled stem cell therapies do not contain any living stem cells. Such practices are cause for concern, as these treatments can mislead patients and the public, and delay the scientific progress needed to turn stem cell therapies into cures.

What the research into stem cells and arthritis shows is that there are opportunities for stem cell treatment to be used as injection therapy alone and in addition to orthopedic surgical procedures. Successful stem cell therapies thus far have resulted mostly in pain relief and improvement in function or quality of life. Only a few limited early studies have demonstrated improvement in new cartilage or bone formation needed to cure arthritis. Exactly how that cartilage regrowth occurs, or even how pain relief is achieved, is still unknown. That means if you have a stem cell procedure, it will be used to treat the symptoms of arthritis only. The ability to cure the disease entirely is not yet available.

No major research studies have specifically investigated stem cell treatment for shoulder arthritis. Much of what is known about stem cells in arthritis comes from research into knee degeneration. Its not known if the successes treating knee arthritis will prove to be similarly beneficial when used for the shoulder. Therefore, current recommendations to treat shoulder arthritis remain the judicious use of gentle pain relievers, exercise and occasional steroid injections. In severe cases, shoulder replacement can provide long-lasting pain relief.

With demonstrable safety and mounting evidence of the effectiveness of stem cell therapy for some orthopedic conditions, potentially all orthopedic disease could be treated with stem cell therapy in the future. But, first, doctors and patients will have to wait until the scientific evidence catches up to the excitement around this promising option. Dr. Shane Shapiro, Orthopedic Surgery and Center for Regenerative Medicine, Mayo Clinic, Jacksonville, Florida

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Welcome to my site providing a direct link to Stem Cell Treatment clinics to improve the health of UK and worldwide residents

Groundbreaking modern technology has brought us a completely natural, drugfree way to heal the

human body. Our primary task is to use your own unique stem cells for the treatment of your own body. Using advanced medical knowledge we can now activate dormant cells (adipose mesenchymal stem cells) to differentiate into the cells we need, and then they can replace the damaged cells. Symtoms become less obvious and disappear, giving relief and the chance to regain a normal functioning body and life!

Having been to a private clinic and experiencing life changing improvements to my own health, I want to let more people know about stemcells and that there is HOPE, to end many disabling conditions that we are led to believe are inevitably going to get worse. By contacting me I will help you to find the right treatment for your individual needs, at a clinic in a country where you will be treated as a distinguished guest, at a price more affordable than you will expect. I can speak from experience, and will gladly guide and help you through the whole process. Please explore my site, read the testimonials and hit the contact me button to speak to some of them! That much is free, and to feel better is truly miraculous!

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An experimental treatment for multiple sclerosis is showing promise in stopping symptoms of the disease, according to a new study that found that a single stem cell transplant could stop or delay symptoms better than some medications. Just over 75 percent of patients who took drugs over a five-year period saw their disease get worse while less than 10 percent of those who had a transplant saw their condition worsen.

As CBS News' Dr. Tara Narula reports, this procedure could be life-changing for some of the 2.3 million people affected by the chronic condition worldwide. Narula met two women who struggled for years with a relapsing-remitting MS. But current drug treatments are expensive, most require daily medications and have serious side effects. These women decided to volunteer for a small clinical trial to test a risky stem cell procedure that appears to be paying off.

Amanda Loy never imagined she'd be battling the Alaska elements on her runs instead of battling her disease. Loy was diagnosed with relapsing-remitting MS, the form that comes and goes in sporadic episodes, bringing her life to a sudden halt.

"Both of my arms went numb and I wasn't really able to use them well," Loy said.

Every month she underwent a drug infusion and took half a dozen other medications, but her symptoms just got worse.

"I started having bladder problems and my balance was really bad, requiring the cane more often," she said. MS is an autoimmune disease where the body attacks itself and damages myelin, the protective covering surrounding nerve cells. With that insulation compromised, the nerves deteriorate and can cause a wide range of symptoms including vision problems, fatigue and weakness. So Loy traveled almost 3,000 miles to Chicago to participate in a trial with the hope of stopping the disease in its tracks.

"Transplants ended up being markedly superior in all the perimeters we looked at," said Dr. Richard Burt, who led the international trial at Northwestern Medicine. "You have to select the right group of patients there's these really aggressive ones that are very relapsing and inflammatory that it works extremely well in."

Here's how it works: a patient's own stem cells are collected and stored. During a two-week stay in the hospital, high-dose chemo is given to wipe out the immune system. Then, the stem cells are infused back into the patient to "re-boot" the body's immune system.

Trudee Manderfield was just 23 when she received her diagnosis. She had trouble walking and temporarily went blind in one eye. In 2013, with an infant daughter, she was ready to try the new treatment. She was scared, but excited about the possibilities.

"I knew that I couldn't just keep going the way that I was going," Manderfield said. "There's a lot of potential side effects, I mean any procedure will have a side effect of death and, as a new mom, I go 'OK, well that would be bad' but I knew that I had to give it a shot."

The transplant might not be a permanent fix. There are serious risks like infertility, infection, and even death. As for Manderfield, she's keeping up with her three active children and Amanda Loy plans to head back to Chicago, not for treatment, but to run the city's marathon in October.

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Stem cell therapy could be life-changing for some multiple ...

As pioneers in the field, TruStem Cell Therapy provides evidence-based care customized to suit patient needs in a safe, effective manner. The discovery of stem cells opened a whole new understanding of how healing works in the human body. TruStem Cell Therapy uses that science to provide access to therapy for painful and debilitating conditions.

Adult stem cells are natural healers that have almost limitless capabilities. Emerging evidence shows that adult stem cells are able to create completely unrelated cells making them valuable assets in the fight to treat many diseases.

TruStem Cell Therapy provides access to the stem cell therapy and the bodys own healing resources as a therapy for life-changing illnesses. Stem cells have the ability to develop into different cell types and aid in repairing the damage done by illness. This means they work with your body to heal tissue, help manage pain and relieve symptoms.

Our board certified surgeons have access to the latest research and state-of-the-art equipment, allowing them to harvest stem cells effectively and efficiently utilizing the least-invasive methods available. The goal is to provide access to patient-centric care with therapy using stem cells, giving the power back to patients. At TruStem Cell Therapy, we specialize in conditions treated with stem cells, such as:

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Conditions and Diseases Treated | Adult Stem Cell Therapy

The usage of hip replacement and surgery has grown dramatically over the years and has even become more common among younger people. However, surgery is not the only solution. At the Institute of Regenerative Medicine, we offer stem cell therapy for hip joints as a safe and effective alternative to hip replacement or surgery.

Stem cell therapy for hip joints is an outpatient procedure that takes a few hours to complete. The process begins with the abstraction of stem cells and platelet rich plasma, also referred to as PRP, from the patients blood and bone marrow.

Stem cells are the natural healing mechanism in the human body. They have the ability to morph into other types of cells that are needed to repair a damaged hip joint such as muscle, cartilage, or bone cells. This results in the stem cells restoring your hip joints naturally without the need of drugs or hip surgery. However, as we age, the number of stem cells in our body and their potency decline. This causes our body to heal slower or not at all from joint injuries in the hip. To counter this, we have developed a proprietary technique to revitalize the patients stem cells and inject a high concentration of them directly to the damaged area of the hip joint with the PRP

Once injected into the hip joint, the stem cells will being restoring the damaged areas of the hip. The PRP, which contains many growth factors, will act as a stimulate for the stem cells, helping to increase their healing potential. After the injection, patients can go home immediately.

Hip surgery often requires patients to stay in a hospital overnight for several days and is followed by several months of physical therapy or training. With a hip replacement, patients are advised to avoid certain movements such as bending and twisting for up to a 12 month period. And even after a patients hip joint has healed after surgery, patients may not be permitted to do certain high impact activities such as sports, jogging, and dancing.

This is not the case for patients that elect to have stem cell therapy for their hip joint injuries. In most cases, patients can resume their active lifestyles without any restrictions or the need of extensive physical therapy in a short amount of time. Typically, patients will begin to see a response from the stem cells in about three weeks after the injection. After that, patients will experience a significant reduction in pain while regaining full mobility of their hip joints in the next several weeks as the stem cells continue to restore the hip joint.

Our medical team will determine the exact treatment and the number of stem cell injections after examining your medical files. Typically, a single stem cell injection is all that is needed to repair most hip joint injuries. If the injury in the hip joint is more severe, then additional injections will be needed. In these cases, we inject additional PRP into the hip joint a month after the first injection to stimulate the initially injected stem cells to prolong their healing process, and then another injection a few weeks after that.

Stem cell therapy for hip joints is a safe alternative to hip replacement or surgery since stem cells and platelet rich plasma (PRP) are biological components that already exist in the human body. Because we harvest the stem cells and PRP for the patients blood instead of other sources, the virtually no risk of rejection or harm to the patients health. Furthermore, the procedure is done by a board certified orthopedic surgeon.

At the Institute of Regenerative Medicine, we have successfully treated patients with various hip injuries and conditions including:

If you suffer from any of these conditions or experience hip pain, contact our office to see if you are a candidate for stem cell therapy for hip joints.

To maximize success, we tailor our stem cell treatment based on the unique needs of our patients. For this reason, the cost for hip stem cell treatment will vary greatly from case to case and can only be determined after our orthopedic specialist has evaluated a patients hip joint. Factors that will determine the cost of stem cell treatment includes:

It is important to note that most health insurance companies will not cover the cost for hip stem cell treatment. However, in many cases, the cost of stem cell therapy can be similar to the cost patients will pay out of pocket for hip surgery and post-surgical care with insurance.

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Stem Cell Therapy: Alternative To Hip Replacement ...

Inside Mark Bermans clinic in Rancho Mirage, California, is a sign hes obliged by law to post. It reads Not FDA Approved.

Patients who come here to the California Stem Cell Treatment Center can get treatments for ailments ranging from sports injuries to muscular dystrophy. For upward of $5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, process it, and inject it back into them.

This is called fat-derived stem cell therapy; the premise is that the stem cells in your fat can jump-start the healing process. The stem cells could be good for repairing everything from Alzheimers to paralysis to neurodegenerative conditions, says Berman. These cells are miraculous for helping heal. We dont have a choice. We have to use them.

The problem is theres not much evidence to back up the claims Berman is making. And its not just him there are more than 100 clinicians in the Cell Surgical Network, a group he co-founded in 2010 to promote the same kind of adult stem cell regenerative medicine he practices. According to a 2017 report by three Food and Drug Administration scientists in the New England Journal of Medicine looking at the benefits and risks of this kind of stem cell therapy, This lack of evidence is worrisome.

Fat-derived stem cells may have a positive effect, says Brad Olwin, a professor of molecular cellular and developmental biology at the University of Colorado Boulder with more than 30 years of experience working with stem cells. They may be beneficial; its clearly a possibility. The problem is the research hasnt been done.

So little evidence exists, in fact, that the Department of Justice, on behalf of the FDA, is suing Bermans clinic as well as a clinic in Florida for experimenting on patients with misleading products. The complaint was filed in May 2018 and the investigation is ongoing, according to the DOJ.

Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize regulation in the field. But despite these efforts to streamline a path to legitimacy for stem cell clinics, unregulated medical procedures persist, at times leading to patient harm.

Currently, the only stem cell therapy approved by the FDA is a bone marrow transplant that uses pluripotent stem cells to treat cancers of the blood and bone marrow.

But doctors in the Cell Surgical Network have moved ahead with using cells for autoimmune, neurologic, and other serious conditions.

And there is a growing number of cases of adverse effects. In 2016, an elderly woman went blind after receiving an injection of stem cells to treat her macular degeneration. She received the treatment at the Stem Cell Center of Georgia an affiliate of Bermans Cell Surgical Network.

More reports of ill-fated procedures have since surfaced across the country, the worst resulting in kidney failure and paraplegia. In December, the Centers for Disease Control and Prevention reported 12 cases of people who suffered bacterial infections from contaminated stem cell treatments. An investigation traced the infections back to a single provider, Genetech, prompting the FDA to issue a warning letter to the company. FDA Commissioner Scott Gottlieb then issued a public statement reaffirming the agencys intent to regulate unapproved treatments.

Bioethicists are sounding the alarm too. In a recent paper in the journal Perspectives in Biology and Medicine, the University of Minnesotas Leigh Turner examined the marketing claims of 716 stem cell clinics in the United States. Often, he found, they were misleading. What at first glance might appear to be credible and compliant clinical research often is highly problematic, he wrote, adding that the individuals most affected are those who often are already dealing with serious health problems and other challenges.

Despite two years of increased scrutiny from the FDA, clinics continue to recruit new patients. Berman insists that repurposed fat-derived stem cells should not be subject to the same regulations as other treatments, and that FDA guidelines are arbitrary and nonscientific. They are a violation of constitutional rights to your own property.

He noted that after the case of the woman with macular degeneration going blind, his networks clinicians no longer inject fat-derived stem cells into patients eyes. But they continue to offer intravenous (bloodstream) injections. We have virtually three or four adverse events, of very little significance or consequence, says Berman, referring to the patients in his network. But according to the FDA, intravenous injections are associated with higher risk.

Other scientists I spoke with say theyre also worried that intravenous treatments may harm patients. Youre taking cells out of one part of your body, and putting them into another. You have absolutely no control after that, says Olwin. He acknowledges the FDAs efforts to crack down on clinics but suggests that much more can be done. They have limited resources to go after people. But I think its irresponsible for doctors and these clinics to be promoting these things.

Some types of stem cells can indeed give rise to virtually any cell in the body providing a platform for regenerating muscle or even rebuilding organs. Stem cells derived from embryos have this power, called pluripotency, but those obtained from adults do not. In order to acquire pluripotency, adult stem cells must be biologically reprogrammed a feat that, when invented, led to a Nobel Prize. These induced pluripotent stem cells allow doctors to treat challenging illnesses such as leukemia.

But clinics like Bermans are not using pluripotent stem cells they are using the mesenchymal stem cells found in fat, which are much more limited in function. Arnold Caplan, the fields pioneer who first gave them the stem cell label, recently advocated for renaming them to prevent doctors from claiming that they can cure the blind, make the lame walk, and make old tissue young again.

BrainStorm, a biotechnology company working with mesenchymal cells, recently gained FDA approval to begin clinical trials to treat patients suffering from multiple sclerosis. But to treat the neurological condition, BrainStorm researchers have developed a method to convert the mesenchymal cells into biological factories that release disease-treating proteins. In other words, BrainStorms therapy doesnt involve mesenchymal cells doing the work on their own what some clinics in the Cell Surgical Network claim mesenchymal cells can do.

Outside of the Cell Surgical Network, other clinics are using patients fat-derived cells but making different claims about the treatment.

I dont say Im doing stem cell therapy, says Dr. Joanne Halbrecht, an orthopedic surgeon and founder of Boulder Regenerative Medicine. Her clinic uses patients fat-derived cells to treat orthopedic conditions, injecting them into joints.

Halbrecht avoids the stem cell label because current research does not support claims that these fat-derived cells can turn into cartilage. Instead, she uses patients fat to cushion their joints. According to Olwin and the FDA, such joint injections are significantly lower-risk than intravenous injections.

Berman also administers direct joint injections. But afterward, he tells me, his clinicians also inject the leftover cells into the patients bloodstream. Halbrecht is adamant that this kind of procedure is unproven and unsafe.

Thats definitive. Its not a question, she says. They are completely wrong because there is zero science behind that.

For clinics to prove the safety and efficacy of their fat-derived stem cell treatments to the FDA, they must run rigorous clinical trials.

But some clinicians argue that even if they were interested in clinical trials, getting the FDAs blessing is too daunting. Clinical trials span years and cost millions of dollars. For small, privately owned clinics, this process is unaffordable.

In response, the FDA unveiled a more feasible clinical trial process, better suited to small businesses. Clinics that want to test a specific treatment can now team up on clinical trials and pool their patients, which can save them time and money. Still, the FDA is offering a grace period of up to 36 months for clinics to comply with its guidelines, allowing many to continue operating on patients without doing clinical trials. In the meantime, the FDA is urging patients to do [their] part to stay safe, according to a consumer warning issued in May.

Unfortunately, thats not so easy. Whether or not a clinic is offering an FDA-compliant treatment can be unclear. Some doctors advertise compliance because the device they use to remove and process a patients fat is technically FDA-approved. But if they then advertise their treatment as an FDA-approved stem cell therapy, they risk misleading patients.

Berman has no plans to pursue clinical trials, even with the new streamlined process. He believes his current model of clinical experimentation is adequate. In the so-called safety studies, he treats paying patients with a wide variety of diseases. But according to the recent bioethics report, Turner found that these pay-to-participate studies are poorly designed and unscientific.

In Bermans view, more patients benefit by obtaining cutting-edge treatments faster. But for every revolutionary treatment developed in a lab, there are nine duds and many unpredictable dangers. And unsanctioned clinics cost patients thousands of dollars and are not covered by insurance. Critics argue that it is unethical to charge patients for experimental procedures, as sanctioned clinical trials rarely cost patients anything.

The economic incentives for unsanctioned stem cell clinics are clear. Starting clinical trials would not only reduce patient revenue but also commit clinics to a costly process known to last for years. Shifting blame to the government and research community, Berman assures me that he and his colleagues are not motivated by self-interest. Were the good guys, he says.

In March, the woman blinded by an unsanctioned stem cell treatment filed a lawsuit against Bermans Cell Surgical Network. Bermans site still advertises treatment for macular degeneration with a link to an application.

But tucked away on Bermans website sits a sort of confession that may surprise the many patients who hear him speak with unwavering assurance. The page reads, We do not claim that these treatments work for any listed nor unlisted condition, intended or implied.

Max Levy is a PhD student in chemical and biological engineering at the University of Colorado Boulder and the senior editor of Science Buffs, a graduate student science blog. He writes about health, medicine, and the environment.

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Orthopaedic surgeon Dr. Stacie Grossfeld discussing Stem Cell Therapy.

Stem Cell Recruitment Therapy is a safe and effective treatment to helpyour body heal itself. It is typically administered during a normal office visit, through asingle injection. Patients have reported improved pain relief and repair for the following conditions:

Stem Cell injections are conveniently administered through a single injection during a normal office visit. Following the injection, patients are typically able to return to everyday, non-high impact activities within 24 to 48 hours.

What benefits does Stem Cell Recruitment Therapy offer?

For more information about stem cell recruitment therapy, or to make an appointment, callOrthopaedic Specialists at a (502)212-2663. Follow along for more information about stem cell recruitment therapy.

Stem cells for stem cell recruitment therapy are obtained through amniotic fluid. Amniotic fluid contains a multitude of proteins and growth factors. Together they create an extra-cellular matrix to recruit the bodys stem cells to reconstruct and regenerate the injured tissue that is causing pain. Amniotic fluid can repair tissue damage, giving patients with arthritis, joint injuries and soft tissue injuries a treatment option that does not involve pain masking medications or surgery.

The amniotic fluid is obtained during full-term cesarean births from healthy donors who have volunteered their placenta and amniotic fluid. All amniotic fluid is collected aseptically and tested prior to processing and determined to be eligible for transplantation by Donors Suitability Standards established by the AATB and the FDA. The products we use are FDA regulated under the 21 CFR Part 1271 and Section 361 of the Public Health and Service Act.

Stem cells take advantage of the bodys ability to repair itself. With a stem cell injection, your physician injects the amniotic fluid containing stem cells into your body. The amniotic fluid has anti-inflammatory properties, similar to cortisone and steroid shots. However, amniotic fluid goes far beyond the benefits of standard injection therapy.

While cortisone and other drugs only provide temporary pain relief, amniotic fluid actually restores degenerated tissue while providing pain relief. The growth factors in the amniotic fluid may recruit your bodys own stem cells, directly mitigating the repair and the regeneration of healthy tissue. Additionally, amniotic fluid injections contain hyaluronic acid, which lubricates joints and tendons, easing the pain and helping restore mobility.

Stem cells have over 200 growth factors. A growth factor is a proteins or enzyme that can grow cartilage, repair scars, reduce inflammation, take away pain, and grow bone. Astem cell can turn into any type of cell. Basically, it doesnt know what it wants to be when it grows up If you put it into the knee, it turns into the cells in the knee joint, it is an imitator so to speak, adapting to the environment where it is placed.

As we get older our stem cells get older. The amniotic stem cells are much more potent. The other advantage of the amniotic stem cells is that you do not have to have the painful procedure where stem cells are harvested out of your pelvis bone.

Typically it can take three to six weeks for a patient to feel the full effect of stem cell recruitment therapy. This is because the treatment utilizes the bodys own healing process.

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Stem Cell Therapy, Amniotic Fluid Injections, Pain Relief

An ideal injectable therapy would combine safe long term anti-inflammatory pain management and long term regenerative healing. The Center for Nonsurgical & Regenerative Orthopedics now offers the most sophisticated and powerful Stem Cell product on the market. ReNu is the only stem cell injection that combines the anti-inflammatory capacity of amniotic tissue with the regenerative power of fetal stem cells.

ReNu is a revolutionary noninvasive treatment in which human amniotic tissue and stem cells are injected into injured tissue to provide relief from pain and stimulate the body's natural healing process. This amniotic tissue contains fetal mesenchymal stem cells that help to regenerate damaged tissue such as cartilage, tendons, and ligaments. The growth factors in the amniotic tissue provide anti-inflammatory, anti-adhesive, and anti-microbial properties to the injured area and can significantly help reduce scarring for quicker healing. Amniotic tissue is also immune privileged, which means there is virtually no chance that your body will reject the treatment.

ReNu stem cells come from the amniotic membrane and fluid of donated placentas following normal childbirth. With the mother's consent, the amnion is removed and harvested from the placenta of pre-screened and tested donors. It is then sterilely processed and undergoes further rigorous testing to assure safety and efficacy. To be clear, while some people may have ethical issues with embryonic stem cell therapy, almost everyone agrees that the use of amniotic stem cell therapy raises no ethical or moral questions.

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ReNu Stem Cell Therapy - Advanced Orthopedics - Nonsurgical ...

Stem cell therapy is a targeted treatment that activates your bodys own natural ability to heal and regenerate. With a simple in-office procedure you will improve your quality of life and potentially avoid surgery.

Research continues to show an increasing number of potential benefits from the anti inflammatory, immunomodulatory, and regenerative actions of stem cells. Stem cell therapy treats pain and chronic conditions at their source, returning you to the things you enjoy.

Our stem cell therapy treatment utilizes umbilical cord derived Mesenchymal Stem Cells from FDA regulated cord banks. Mesenchymal Stem Cells are specialized cells that are able to receive signals from the other cells in your body. Stem cells then seek out inflammation and degeneration and go to that location to begin repairing tissue.

Stem cells have been shown to help repair muscle, bone, cartilage and tendons. Research has indicated that stem cells can benefit a wide variety of health complications and may assist in individuals living stronger, healthier lives.

Our mission is simple: Change the lives of our patients by providing an integrative, holistic approach to healing.

We help people suffering from chronic health conditions, chronic pain, autoimmune issues, and many other undiagnosed syndromes and health problems.

We are passionate about caring for our patients who, until now, were not able to find answers and treatments for their underlying health issues.

Regenerative medicine through stem cell therapy is the future of health care and, for our patients, THE FUTURE IS NOW!

Are you a candidate for regenerative stem cell therapy? The answer is YES if you suffer from any of the following:

Were here to help you heal and restore your health today! Please contact us now using the form below to explore how stem cell therapy can help you find relief and embrace your life again!

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Stem Cell Therapy in Richmond Start Healing Chronic Pain ...

Stem cell therapy has been a hot topic in the press lately. With more and more medical providers offering stem cell treatments, patients around the country have been wondering, Is Stem Cell Therapy covered by Medicare.

Stem Cell research has shown that its an effective treatment for chronic joint pain and arthritis sufferers and more recent studies are starting to show the benefit for treatment of neurological disorders as well. (M.S., Parkinsons, and Stroke)

So the team at Stem Cell: The Magazine, have put together some information to answer this question of insurance coverage for potential medical enrollees seeking stem cell and regenerative treatments.

So what is the answer to Does Medicare cover Stem Cell therapy?

From the research that we have pulled up regarding Medicare Insurance Coverage for stem cell therapy; medicare does cover stem cell treatments, but not for some of the chronic degenerative conditions that regenerative treatments (stem cell therapy) can help them with.

You can see in this publication from BCBS that stem cell therapy is covered for the following conditions:

INDICATIONS FOR COVERAGE

Section 2.aAllogeneic Hematopoietic Stem Cell Transplantation (HSCT) eligible for coverage in the following:a) The treatment of leukemiab) The treatment of severe combined immunodeficiency disease (SCID) and for the treatment of Wiskott-Aldrich syndrome.ORc) The treatment of Myelodysplastic Syndromes (MDS) pursuant to Coverage with Evidence Development (CED) in the context of a Medicare-approved, prospective clinical study.3. Autologous Stem Cell Transplantation(AuSCT) is eligible for coverage in the following:a) Acute leukemia in remission who have a high probability of relapse and whohave no human leucocyte antigens (HLA)-matched;ORb) Resistant non-Hodgkins lymphomas or those presenting with poor prognosticfeatures following an initial response;ORc) Recurrent or refractory neuroblastoma;ORd) Advanced Hodgkins disease who have failed conventional therapy and have no HLA-matched donor.

You can see that outside of the listed conditions above, Medicare does not cover stem cell therapy for treatments joint conditions or neurological conditions that patients are more commonly seeking treatment for.

In this article, it clearly states that stem cell therapy for the coverage of orthopedic conditions is not covered:

The orthopedic application of stem-cell therapy is not addressed within the stem cell transplantation NCD. (NCD = National Care Determinations)

What this means for any patient that is looking to receive regenerative and stem cell treatments for orthopedic conditions such as:

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Medicare will not cover treatment for these conditions. In fact, most major medical carriers will not provide coverage for these treatments either.

Many chronic joint pain sufferers wonder why Medicare and most major carriers dont provide coverage for these treatments if they are so effective, but there is a simple answer for why this is.

Medicare and most major health insurance are for emergency conditions. Regenerative medicine is still considered an elective treatment, close to wellness care. Insurance carriers are not in the business of providing wellness for coverage for their participants.

We found a great video that explains more about this by John R Hoffman at Arcadia University. In it he describes the challenges of Medicare coverage for Stem Cell Therapy.

Our hope at Stem Cell: The Magazine is that as more and more patients continue to seek out treatment of their orthopedic and neurological conditions using stem cell and regenerative treatments, that Mediare and major health insurances will accept stem cell as the first treatment for these chronic conditions.

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Is Stem Cell Therapy Covered by Medicare? was last modified: October 3rd, 2018 by Stem Cell The Magazine

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Is Stem Cell Therapy Covered by Medicare?