Archive for the ‘Stem Cell Treatment’ Category

Stem Cell Treatments Flourish With Little Evidence That …

Stem Cell Treatment | Posted by admin
May 16 2019

The companys website, loaded with impressive videos and testimonials from patients, is a major draw for aging gym rats searching the internet for relief from sore knees, shoulders, hips and backs.

Through the website, Dr. Centeno regularly criticizes other stem cell businesses, and has acted as an expert witness for injured patients suing his competitors.

The company did run afoul of the F.D.A. in 2008 over its use of cells cultured and multiplied in a lab to increase the stem cell count. After a protracted legal battle, Regenexx quit using that technique in the United States, but began offering it at a clinic on Grand Cayman.

This has always been about creating a less invasive orthopedic solution, what I call interventional orthopedics, Dr. Centeno said. He predicts a sea change in orthopedics similar to the revolution in cardiology, where much open-heart surgery was replaced by less invasive procedures.

While regulators may not consider them high risk, stem cell treatments involving bone marrow are not trivial. Collecting bone marrow involves forcefully puncturing the back of the hip bones in several spots, a painful process that requires local anesthesia. Then, pressure is applied to prevent bleeding, and the sites are bandaged to prevent infection.

Injecting the bone marrow or platelet extracts into the knee takes skill, even with X-rays to guide the needle. The injections can cause pain and irritation, and patients are usually sent home with leg braces that they will wear for a few weeks.

Sterile techniques are essential.

Whenever injections are administered to the joint, there is always a risk of introducing infection, said Dr. Kiran M. Perkins, who has investigated such illnesses at the Centers for Disease Control and Prevention. With stem cell treatments, she added, there are a lot of steps along the way where something could go wrong and you could have the introduction of microorganisms.

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Stem Cell Treatments Flourish With Little Evidence That ...

Stem-Cell Treatment for Blindness Moving Through Patient …

Stem Cell Treatment | Posted by admin
May 16 2019

A new treatment for macular degeneration is close to the next stage of human testinga noteworthy event not just for the millions of patients it could help, but for its potential to become the first therapy based on embryonic stem cells.

This year, the Boston-area company Advanced Cell Technology plans to move its stem-cell treatment for two forms of vision loss into advanced human trials. The company has already reported that the treatment is safe (see Eye Study Is a Small but Crucial Advance for Stem-Cell Therapy), although a full report of the results from the early, safety-focused testing has yet to be published. The planned trials will test whether it is effective. The treatment will be tested both on patients with Stargardts disease (an inherited form of progressive vision loss that can affect children) and on those with age-related macular degeneration, the leading cause of vision loss among people 65 and older.

The treatment is based on retinal pigment epithelium (RPE) cells that have been grown from embryonic stem cells. A surgeon injects 150 microliters of RPE cellsroughly the amount of liquid in three raindropsunder a patients retina, which is temporarily detached for the procedure. RPE cells support the retinas photoreceptors, which are the cells that detect incoming light and pass the information on to the brain.

Although complete data from the trials of ACTs treatments have yet to be published, the company has reported impressive results with one patient, who recovered vision after being deemed legally blind. Now the company plans to publish the data from two clinical trials taking place in the U.S. and the E.U. in a peer-reviewed academic journal. Each of these early-stage trials includes 12 patients affected by either macular degeneration or Stargardts disease.

The more advanced trials will have dozens of participants, says ACTs head of clinical development, Eddy Anglade. If proved safe and effective, the cellular therapy could preserve the vision of millions affected by age-related macular degeneration. By 2020, as the population ages, nearly 200 million people worldwide will have the disease, estimate researchers. Currently, there are no treatments available for the most common form, dry age-related macular degeneration.

ACTs experimental treatment has its origins in a chance discovery that Irina Klimanskaya, the companys director of stem-cell biology, made while working with embryonic stem cells at Harvard University. These cells have the power to develop into any cell type, and in culture they often change on their own. A neuron here, a fat cell thereindividual cells in a dish tend to take random walks down various developmental paths. By supplying the cultures with fresh nutrients but otherwise leaving them to their own devices for several weeks, Klimanskaya discovered that the stem cells often developed into darkly pigmented cells that grew in a cobblestone-like pattern. She suspected that they were developing into RPE cells, and molecular tests backed her up.

Now that her discovery has advanced into an experimental treatment, Klimanskaya says she is excited by the hints that it may be able to preserve, and perhaps restore, sight. She recalls a voice mail she received during her second year at ACT: a person blinded by an inherited condition thanked her for her work, whether or not there was a treatment available for him. When you get a message like this, you feel like you are not doing it in vain, she says.

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Stem-Cell Treatment for Blindness Moving Through Patient ...

Stem Cell Therapy | Stem Cell Treatment | Charlotte, NC

Stem Cell Treatment | Posted by admin
May 14 2019

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

Stem Cell Therapy New York | Stem Cell Treatment …

Stem Cell Treatment | Posted by admin
May 14 2019

Stem cell therapy uses a patients own stem cells to treat minor to moderate conditions formally where surgery would be the primary option. Stem cell therapy is an alternative to surgery through an office based procedure. Through advanced technology stem cell therapy is now a quick and easy alternative to surgery.

What are stem cells?

Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as of internal repair system, dividing essentially without limit to replenish other cells. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.

Regenerative Growth Factors Stem cells have high natural growth factors that promote healing. These growth factors also naturally decrease inflammation.

Patients stem cells are obtained from their pelvic (hip) bone. The practitioner then concentrates the stem cells over 10 fold in a special centrifuge.

This office based procedure takes 30 minutes. Patients can leave at the conclusion of the procedure.

A local anesthetic is used. This results in minimal discomfort.

There have been numerous clinical studies that show significant and lasting reduction in pain for a variety of injuries. Common injuries include early to advanced arthritis, knee and shoulder pain.

Multiple clinical studies have shown that when effective, the results last many years.

Yes see the article section

85% of patients experience a benefited result from treatment

Most patients feel no improvement for at least 3 weeks and possible 6-8 weeks. Once you feel improvement, you will notice continued improvement expanding over 6 months.

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Stem Cell Therapy New York | Stem Cell Treatment ...

Stem Cell Treatment for Ataxia – Stem Cell Treatment Now

Stem Cell Treatment | Posted by admin
Apr 27 2019

How does ataxia affect the patient? The disease is characterized by progressively disabling clinical manifestations. Patients show symptoms of gait instability or dysarthria and may begin to fall without warning. Gradually they present progressive limitations in their activities, lose the ability to walk, become bedridden and fully dependent. Other clinical manifestations include astasia, impaired fine motor skillsand intention tremor (cerebellar tremor). The cerebellar syndrome is often associated with other neurological signs such as pyramidal or extrapyramidal signs, ophthalmoplegia, and cognitive impairment.

How to diagnose ataxia? Most people dont know what ataxia is and may overlook the early symptoms. Anyone with progressive gait disorder or imbalance should be evaluated by a neurologist. MRI is recommended in all cases. If a treatable cause is not discovered, a gene test should be done. In about 60 percent of the cases, the gene test will determine the type of ataxia.

What is the efficacy of conventionaltreatments? Until now, conventional treatments are generally used to alleviate the symptoms, not the disease itself. The movement disorders can be managed using pharmacological, physical and occupational therapies to minimize the damage and to promote the mobility as long as possible but overall current treatment remains retardant.

What are the difference between autosomal dominant and autosomal recessive ataxias? Autosomal dominant and autosomal recessive ataxias are hereditary ataxias, and spinocerebellar ataxia (SCA) and Friedreich's ataxia (FRDA) are the most common forms of hereditary ataxia. Autosomal dominant genes express themselves when present. Autosomal recessive genes will only express themselves when in the homozygous state -- i.e., both genes in the gene pair are the recessive gene form. Thus, recessive genes can be "carried" by those whose phenotype does not exhibit the gene characteristic, while dominant genes cannot be "carried". Therefore, generally autosomal dominant ataxias are easier to express andat a higher morbiditythan autosomal recessive ataxias.

What is the role of Purkinje cells, where can we find those cells ? Purkinjecellsare a type of neuron found in the cerebellar cortex, at the base of the brain.They are among the largest neurons and are responsible for most of the electrochemical signaling in the cerebellum. ThePurkinjecellsand the cerebellum are essential to the body's motor function. Disorders involving thePurkinjecellsusually negatively affect the patient's movements.

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Stem Cell Treatment for Ataxia - Stem Cell Treatment Now

Knees – Stem Cell Therapy For Pain | Stem Cell Seminars …

Stem Cell Treatment | Posted by admin
Apr 22 2019

Surgical options for those suffering from painful knee injuries can range from knee surgery to complete knee replacement. Recent studies have shown that most surgeries dont have a 100% success rate and there is chance of the pain and discomfort resurfacing. Knee replacement surgery can be extremely traumatic and it has the risk of toxic artificial particles entering the bloodstream. Apart from this, months of a painful recovery phase is required to regain the strength and mobility following the surgeries. Most surgeries also boost the degeneration process, which can lead to osteoarthritis.

Knee replacement surgery carries many serious risks and complications, but is often considered as the most-accepted treatment method for those dealing with significant arthritis or injury in knee joints.

Surgery should always be the last option, however, it is often perceived to be the only treatment alternative by most patients. At Stem Cell Therapy for Pain, we have assisted several patients with severe arthritis problems in avoiding knee replacement surgery through stem cell treatment for knees, which enabled them to carry out the things they love without being burdened by pain. We have seen exciting results on tricky knee injury cases, including complete ligament and muscle tears. Our expert physicians ensure that patients experience little to no downtime after the treatment, and can bounce back to their daily routine immediately.

The most common form of arthritis is Osteoarthritis. It is also known as wear-and-tear arthritis, since the cartilage thins and eventually breaks down. The cartilage cushions the joints where two bones meet, so any degeneration can seriously impact our body.

Stem cell treatments for knees offered by Stem Cell Therapy for Pain are designed to target the knee joints to assist with the formation of new cartilage cells. The aim of each stem cell injection for knee pain is to re-inject the amniotic or adult stem cells into the knee joint to boost cartilage or chondrocytes cell creation. Stem cells have a natural anti-inflammatory chemical that helps to alleviate osteoarthritis pain and inflammation in the knee joint.

If you have chronic knee pain due to a past injury or arthritis, an injury to the knee cartilage, meniscus, ligaments, you might be an ideal candidate for stem cell therapy for knees.

To learn more about services like stem cell therapy for osteoarthritis, get in touch with us today. Lets work on restoring your life, one treatment at a time!

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Knees - Stem Cell Therapy For Pain | Stem Cell Seminars ...

Second patient free of HIV after stem-cell therapy

Stem Cell Treatment | Posted by admin
Apr 19 2019

A person with HIV seems to be free of the virus after receiving a stem-cell transplant that replaced their white blood cells with HIV-resistant versions. The patient is only the second person ever reported to have been cleared of the virus using this method. But researchers warn that it is too early to say that they have been cured.

The patient whose identity hasnt been disclosed was able to stop taking antiretroviral drugs, with no sign of the virus returning 18 months later. The stem-cell technique was first used a decade ago for Timothy Ray Brown, known as the Berlin patient, who is still free of the virus.

So far, the latest patient to receive the treatment is showing a response similar to Browns, says Andrew Freedman, a clinical infectious-disease physician at Cardiff University in the UK who was not involved in the study. Theres good reason to hope that it will have the same result, he says.

Like Brown, the latest patient also had a form of blood cancer that wasnt responding to chemotherapy. They required a bone-marrow transplant, in which their blood cells would be destroyed and replenished with stem cells transplanted from a healthy donor.

But rather than choosing just any suitable donor, the team led by Ravindra Gupta, an infectious-disease physician at the University of Cambridge, UK picked a donor who had two copies of a mutation in the CCR5 gene that gives people resistance to HIV infection. This gene codes for a receptor which sits on the surface of white blood cells involved in the bodys immune response. Normally, the HIV binds to these receptors and attacks the cells, but a deletion in the CCR5 gene stops the receptors from functioning properly. About 1% of people of European descent have two copies of this mutation and are resistant to HIV infection.

Guptas team describes the results in a paper due to be published in Nature on 5 March. The researchers report that the transplant successfully replaced the patients white blood cells with the HIV-resistant variant. Cells circulating in the patients blood stopped expressing the CCR5 receptor, and in the lab, the researchers were unable to re-infect these cells with the patients version of HIV.

The team found that the virus completely disappeared from the patients blood after the transplant. After 16 months, the patient stopped taking antiretroviral drugs, the standard treatment for HIV. In the latest follow-up, 18 months after stopping medication, there was still no sign of the virus.

Gupta says that its not yet possible to say whether the patient has been cured. This can only be demonstrated if the patients blood remains HIV free for longer, he says.

But the study does suggest that Browns successful treatment ten years ago wasnt just a one-off. Gupta says that the latest patient received a less aggressive treatment than Brown to prepare for the transplant. The new patient was given a regimen consisting of chemotherapy alongside a drug that targets cancerous cells, while Brown received radiotherapy across his entire body in addition to a chemotherapy drug.

This suggests that, to be successful, stem-cell transplants in HIV patients would not necessarily need to be accompanied by aggressive treatments that might have particularly severe side effects, says Gupta. The radiation really does knock the bone marrow and make you very sick.

Graham Cooke, a clinical researcher at Imperial College London, points out that this kind of treatment wouldnt be suitable for most people with HIV who dont have cancer and so dont need a bone-marrow transplant, which is a serious procedure that can sometimes have fatal complications. If youre well, the risk of having a bone-marrow transplant is far greater than the risk of staying on tablets every day, he says. Most people with HIV respond well to daily antiretroviral treatment.

But Cooke adds that for those who need a transplant to treat leukaemia or other diseases, it seems reasonable to try and find a donor with the CCR5 mutation, which wouldnt add any risk to the procedure.

Gero Htter, who led Browns treatment and is now medical director of the stem-cell company Cellex in Dresden, Germany, agrees that this kind of treatment could only ever be used for a small group of patients. But he hopes that the paper will stimulate a renewed interest in gene therapies that target CCR5, which could be applied to a much broader group. The real breakthrough, we are still waiting for, he says.

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Second patient free of HIV after stem-cell therapy

Regenerative Solutions of NJ

Stem Cell Treatment | Posted by admin
Apr 12 2019

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Over 32 million Americans suffer from chronic obstructive pulmonary disease (also known as COPD). COPD is most commonly the result of smoking or exposure to air pollution, fumes or inhaled irritants. This disease progresses more quickly in smokers compared to non-smokers. It can be associated with chronic bronchitis, emphysema and asthma.

Someone in the U.S. has a stroke every 40 seconds, and once stroke symptoms start, every minute counts, so its vital to seek immediate medical attention, or it can be fatal. Stroke accounts for 1 out of every 20 deaths in the U.S., according to the American Stroke Association. Seeking medical attention immediately after stroke symptoms is crucial to survival, but seeking therapy right after a stroke is essential to recovery.

Parkinsons disease is a neurodegenerative brain disorder thatafflicts more than one million people in the U.S., with over 60,000 new cases being diagnosed each year. It leads to progressive deterioration of motor function, and the disease progresses slowly in most people who develop it. Parkinsons requires a medical diagnosis, and the disease occurs mostly in people around 60 years old, but can also affect younger adults as well.

Living with noticeable hair loss and thinning hair can be discouraging. It can affect your self-confidence, and until recently there were only a few options available. These either required surgery which left scars, or left people with a disappointing lack of results. Hair loss affects both men and women. In the U.S., more than 35 million men and 21 million women suffer from hair loss.

Erectile dysfunction can be a sensitive subject for many. By definition, erectile Dysfunction (ED) is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse. ED, or impotence, is a common problem for men of all ages. It is estimated that 70% of all ED cases may be attributable to diminished blood flow. ED often happens as a result of trauma or the weakening of blood vessels due to age, or the result of another underlying medical condition.

One out of every three Americans experience joint and chronic pain on a daily basis, and unfortunately, many have learned to live with it. Depending on the severity, they may find temporary pain relief with daily anti-inflammatory medication and limiting activities. Many individuals endure the pain as long as they can, then opt for extreme measures, like joint replacement, in an effort to maintain functionality.

One out of every three Americans experience joint and chronic pain on a daily basis, and unfortunately, many have learned to live with it. Depending on the severity, they may find temporary pain relief with daily anti-inflammatory medication and limiting activities. Many individuals endure the pain as long as they can, then opt for extreme measures, like joint replacement, in an effort to maintain functionality.

Neuropathy is either damage to or disease which affects nerves in the body. It affects about 6-7% of the population, and may be a chronic, long-term condition where symptoms begin and progress slowly or begin suddenly and have a rapid progression. There are several factors and conditions that can contribute to neuropathy including diabetes, heredity disorders, inflammatory infections, auto-immune diseases and more.

In the US, it is becoming more common to seek alternative treatments for medical conditions using stem cell therapy or stem cell based treatments. Some of the options that you may have been offered include cord blood products, whartons jelly, adipose derived stem cells, bone marrow derived stem cells.and Exosomes.

Some products are available from labs for physicians to administer to patients, while other stem cell based options are harvested directly from a patient, then readministered to the patient.

At Regenerative Solutions of NJ, Dr. Spiel utilizes Exosomes from Kimera Labs. Exosomes have quickly grown in popularity amongst scientists, physicians and patients to become the treatment of choice for patients who can benefit from regenerative therapies. Exosomes are best known for safety and efficacy. They are commonly used to treat many medical conditions with excellent results.

If you are considering stem cell based treatment, learn the benefit of EXOSOMESsafety and efficacy.

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Regenerative Solutions of NJ

Why expensive, unproven stem cell treatments are a new health …

Stem Cell Treatment | Posted by admin
Apr 08 2019

The onlinevideoseems to promise everything an arthritis patient could want.

The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and regenerative medicine for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, Its completely healed.

Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.

I dont have any pain that stops me from doing anything I want, Hyland says.

Critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The videos cheerleading tone mimics theinfomercialsused to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, saidDr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine. But the marketing video wasnt filmed by a little-known operator.

It was sponsored bySwedishMedical Center, the largest nonprofit health provider in the Seattle area.

Swedish is one of a growing number ofrespected hospitalsandhealth systems including theMayo Clinic, theCleveland Clinicand theUniversity of Miami that have entered the lucrative business ofstem cellsandrelated therapies, including platelet injections. Typical treatments involveinjecting patients joints with their own fatorbone marrowcells, or with extracts ofplatelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though theevidencesupporting these experimental therapies isthin at best, Knoepfler said.

Hospitals say theyre providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendybut unproventreatments.

TheFood and Drug Administrationis attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked toseveral cases of blindnessand atleast 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out ahandful of exceptions,as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.

Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinics campus in Florida.

While hospital-based stem cell treatments may be legal, theres nostrong evidencethey work, said Leigh Turner, an associate professor at the University of Minnesotas Center for Bioethics who has published a series of articles describing the size and dynamics of thestem cell market.

FDA approval isnt needed and physicians can claim they arent violating federal regulations, Turner said. But just because something is legal doesnt make it ethical.

For doctors and hospitals, stem cells are easy money, Turner said. Patients typically paymore than $700a treatment for platelets and up to$5,000for fat and bone marrow injections. As a bonus, doctors dont have to wrangle with insurance companies, which view the procedures asexperimentaland largelydont cover them.

For doctors and hospitals, stem cells are easy money.

Its an out-of-pocket, cash-on-the-barrel economy, Turner said. Across the country, clinicians at elite medical facilities are lining their pockets by providingexpensive placebos.

Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.

Its lucrative. Its easy to do. All these reputable institutions, they dont want to miss out on the business, said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. It preys on peoples desperation.

In a joint statement, Pourcho and Swedish defended the online video.

The terminology was kept simple and with analogies that the lay person would understand, according to the statement. As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.

But Knoepfler said the guests on the video make several unbelievable claims.

At one point, Dr. Pourcho says thatplatelets release growth factorsthat tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and so you dont get, say, eyeball in your hand.

Knoepfler, who has studied stem cell biology for two decades, said he has never heard of any possibility of growing eyeball or other random tissues in your hand. Knoepfler, who wrote about the video in February on his blog,The Niche, said, Theres no way that the adult brain could send that kind of stem cells anywhere in the body.

The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called New Day Northwest. Although much of the show is produced by the KING 5 news team, some segments like Pourchos interview are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.

After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasnt labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.

The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material, Rose said. We value the publics trust.

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

In October, theFederal Trade Commissionfined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinsons disease and other serious diseases.

In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called bad actors.

Withmore than 700stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.

There are clearly bad actors who are well over the line and who are creating significant risks for patients, Gottlieb said.

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

Gottlieb, set to leave office April 5, said hes also concerned about the financial exploitation of patients in pain.

Theres economic harm here, where products are being promoted that arent providing any proven benefits and where patients are paying out-of-pocket, Gottlieb said.

Dr. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, said there is a broad spectrum of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are for just about anything. Hospitals operate somewhere in the middle, Marks said.

The good news is that theyre somewhat closer to the most rigorous academics, he said.

The Mayo Clinics regenerative medicine program, for example, focuses conditions such asarthritis, where injections pose few serious risks, even if thats not yet the standard of care, Shapiro said.

Rickert said its easy to see why hospitals are eager to get in the game.

The market for arthritis treatment is huge and growing. At least30 million Americanshave the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet injections for arthritis generatedmore than $93 millionin revenue in 2015, according to an article last year in The Journal of Knee Surgery.

We have patients in our offices demanding these treatments, Shapiro said. If they dont get them from us, they will get them somewhere else.

Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. Ina paper published this year,Shapiro described the hospitals consultation service, in which doctors explain patients options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.

Most of the patients do not get a regenerative [stem cell] procedure, Shapiro said. They dont get it because after we have a frank conversation, they decide, Maybe its not for me.

Although some hospitals boast of high success rates for their stem cell procedures,published researchoften paints a different story.

TheMayo Clinic websitesays that 40 to 70% of patients find some level of pain relief. Atlanta-basedEmory Healthcareclaims that 75 to 80% of patients have had significant pain relief and improved function. In the Swedish video, Pourcho claims we can treat really any tendon or any joint with PRP.

The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.

But PRP hasnt been proven to help every part of the body, he said.

PRP has been linked to serious complications when injected to treatpatellar tendinitis,an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.

People will say, If you inject PRP, you will return to sports faster, said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. But that hasnt been proven.

A2017 studyof PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But thats nothing to brag about, Rickert said, given thathyaluronic acid therapy doesnt work, either. While some PRP studies have shown morepositive results, Rickert notes that most were so small orpoorly designedthat theirresults arent reliable.

In its 2013 guidelines for knee arthritis, theAmerican Academy of Orthopaedic Surgeonssaid it is unable to recommend for or against PRP.

PRP is sort of a buyer beware situation, said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. Its the poor mans approach to biotechnology.

Tests of other stem cell injections also have failed to live up to expectations.

Shapiro published a rigorously designed study last year inCartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70% of patients, Fu said.

A 2016 review in theJournal of Bone and JointSurgery concluded that the value and effective use of cell therapy in orthopaedics remain unclear. The following year, a review in theBritish Journal of Sports Medicineconcluded, We do not recommend stem cell therapy for knee arthritis.

Shapiro said hospitals and health plans are right to be cautious.

Many patients have trouble sorting through the hype.

The insurance companies dont pay for fat grafting or bone-marrow aspiration, and rightly so, Shapiro said. Thats because we dont have enough evidence.

Rickert, an orthopedist in Bedford, Ind., said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldnt be charged for these services until theyve been tested and shown to work.

Orthopedists surgeons who specialize in bones and muscles have a history of performing unproven procedures, includingspinal fusion, surgery forrotator cuff diseaseandarthroscopyfor worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.

Some argue that joint injections shouldnt be marketed as stem cell treatments at all.

Piuzzi said he prefers to call the injections orthobiologics,noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said. In fat tissue, only about 1 in 2,000 cells is a stem cell, according to a March paper inThe Bone & Joint Journal. Stem cells are even rarer in bone marrow, where 1 in 10,000 to 20,000 cells is a stem cell.

Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. Theres no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they dont know why some patients who receive platelet injections feel better, but others dont.

So, it comes as no surprise that many patients have trouble sorting through the hype.

Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.

When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, it seemed like an answer to a prayer, said Walsh, of Stuart, Fla. Youre so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.

The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. My only regret, she said, is that I wasted so much time and money.

KaiserHealthNewsis an editorially independent program of the Henry J.KaiserFamily Foundation, a nonprofit, nonpartisanhealthpolicy research and communication organization not affiliated withKaiserPermanente. You can view the original report on itswebsite.

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Why expensive, unproven stem cell treatments are a new health ...

Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny …

Stem Cell Treatment | Posted by admin
Apr 03 2019

Cord for Life also fared poorly on an F.D.A. inspection in November, according to the letter, which listed numerous deficiencies in sanitation, like employees wearing the same non-sterile smocks for up to two weeks, not changing gloves and not cleaning equipment properly.

The F.D.A. gave the company 15 days to present a plan for correcting the deficiencies, and noted that failing to act on the problems could result in seizure and/or injunction by the agency.

Donald Hudspeth, general manager of Cord for Life, said the company had already corrected the problems identified in the inspection. Mr. Hudspeth also said that Cord for Life was unaware that the F.D.A. expected it to submit more proof of completion.

In addition, he said the company had not received any reports of adverse reactions from its products in its 25-year history.

The F.D.A. did not release the names of the recipients of the other 20 letters.

In their statement, Dr. Gottlieb and Dr. Marks dismissed claims by some stem cell businesses that they are exempt from F.D.A. regulations because their practitioners extract stem cells from a patients own fat or bone marrow and then return the cells to the same patient. The cells do not qualify as drugs and do not need regulation, the clinics argue.

The two officials disagreed: Stem cell products can create unique and serious risks depending on how theyre manipulated once theyre taken from the body and how they are used once theyre reinserted in the body.

The statement also noted that the F.D.A. was halfway through a three-year period of what it calls enforcement discretion, meaning that in 2017 it put stem-cell clinics on notice that their treatments were likely to come under F.D.A. authority, but that instead of cracking down immediately it was giving them time to learn what rules applied to them and to comply.

So far, though, the industrys response has been modest, the agency said, adding that once the three-year period is over, in November 2020, well step up our oversight.

Read more here:
Risky Stem-Cell Treatments Come Under F.D.A. Scrutiny ...