At ClinicalTrials.Gov, Untested Stem Cell Clinics …

Stem cell cultures growing in multi well sample tray.

Andrew Brookes/Getty Images

Macular degeneration is the most common cause of vision loss among the elderly. But for some people with the disease, a shot of stem cells to the peeper was all they needed to see again . For others, treatment left them permanently blind . What gives? Stem cell treatments like the one described abovehappening every day in 600 clinics across the USare not approved by the FDA, and in fact have never been tested in a clinical trial.

Eyes arent the only organ getting stabbed full of stem cells. Around the country, more doctors are marketing the therapy to treat everything from diabetes to asthma to erectile dysfunction. The procedure usually involves sucking out some of a patient's fat tissue with a liposuction needle, isolating their stem cells, and reinjecting them back into the place in their body that needs most healing. But because these are living tissues unique to every individual, results may vary. Advocates of the therapy say thats just the cost of doing cutting-edge medicine. Except, any proof they have that it is effective comes from data collected on patients who pay thousands of dollars for the treatment. Usually people pay money for medicine after theres proof it works. In the last few years, some of these stem cell clinicians have begun posting large-scale studies on a government-run website called ClinicalTrials.gov, even though they're often not up to medical research standards or even in compliance with federal regulations. This allows them to masquerade their pay-to-participate studies as legit science.

According to a paper published today by the University of Minnesota, US companies have successfully registered 18 patient-sponsored stem cell studies on that publicly funded website. Only 7 of them disclose that patients pay their own way. None of them list the costs, which can range from $5,000 to $15,000 a treatment, outright. And none of them are actual clinical trials in the randomized, blinded, gold-standard sense of the phrase. Instead, theyre observational studies, based mostly on quality of life questionnaires that ask if youve had any adverse reactions to the procedure.

Leigh Turner, the bioethicist who penned todays perspective and who has become somewhat of a watchdog in the ballooning stem cell clinic industry, says this amounts to hijacking a public good and repurposing it into a free marketing tool. They dont have to pay for ads on television, people just come to them because its this trusted national resource, he says. Its all meant to suggest a seal of approval from the federal government. And thats whats so dangerously misleading, because it doesnt mean that all. It just means someone filled out a form and pressed a button.

Following the passing of the Food and Drug Administration Modernization Act of 1997, the National Library of Medicine established ClinicalTrials.gov to serve as a source of information about publicly and privately supported clinical trials for patients, their families and caregivers, doctors and nurses, and the public. But the NIH doesnt independently verify the scientific validity of any trials posted to the site beyond a limited quality control review. That doesnt really include things like sound study design, compliance with current regulations, or ethical guidelines. In fact, the process is largely automated, and relies almost entirely on the honor system.

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NIH said in a statement that it is continuing to evaluate ways to improve its outreach to make sure that trial participants understand potential risks and benefits. That included adding a prominent disclaimer on the ClinicalTrials.gov homepage in March 2017, stating: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study.

But that hasnt stopped stem cell therapy slingers from touting their clinical bonafides. Cell Surgical Network, an umbrella organization for more than 50 clinics that market the treatment directly to consumers, first registered on ClinicalTrials.gov in October of 2013. At the time, the organization put out a press release noting that the NIH had registered its approved safety study, and that it was now cleared to enroll 3,000 people to study the adverse effects of stem cell treatments on arthritis, cardiomyopathy, Parkinsons, ALS, and a host of other inflammatory and neurological diseases. The ClinicalTrials.gov listing of this study does not mention that research subjects are charged an average of $6000 to participate.

Elliot Lander, a urologist and co-founder of Cell Surgical Network says those costs are necessary because stem cell therapies dont make money like pharmaceuticals dothey can't be packaged up and mass-produced. Which means pharma companies and research institutions arent interested in footing the bill for clinical trials. And he says that while it might be worth noting the costs upfront, the NIH doesnt have a mandatory policy about including fees. Stem cell treatments have no business model, he says. So its left to physicians like myself to do the right thing by my patients, and get them regenerative medicine now, not 10-15 years from now. People dont need to be protected by Leigh Turner, they can do their own due diligence.

So far, at least 6,000 people have followed their due diligence to a treatment at one of Cell Surgical Networks clinics. The network keeps a database of all its patients and their outcomes, hoping for the day when the FDA decides to go from merely ignoring the proliferation of un-approved treatments to giving them a green light based on post-market data (a regulatory middle path floated by advocates like Lander.) In the meantime though, Cell Surgical Network is working with the FDA on an application for a real clinical trial, limited to just knee pain treatmentsthat will even include a randomized placebo. Its going to take us years and a few million dollars, says Lander. The walls are really high for this kind of thing. As they should be.

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At ClinicalTrials.Gov, Untested Stem Cell Clinics ...

Stem Cell Therapy and Its Revolutionary Purposes Guardian … – Guardian Liberty Voice

Stem cell therapy is reaching another stage in the healthcare world by offering hope through revolutionary solutions to complex diseases. However, with progress come controversy.

Part of the debate lies in the disbelief stem cell therapy is as revolutionary asresearchers claim. The forerunners of this therapy want to replace the current treatment of Alzheimers, and cancer. There are even biotech scientists who claim experiments have shown promisebringing thebrain dead back to life, although, nothing concrete has been published.

Supporting scientists of the therapy have solid evidence thatevery disease originatesin specific cells. It is key to work with cells to find a potential cure for any illness. The first cell of a human is the stem cell; a pluripotent cell is a component of life and capable of replicating any other cell in the body. In fact, every cell in the human body comes from this cell. Pluripotent cellsare found in embryos or created from other cells making the process expensive.

With a cell capable of transforming into others, lab developers hope to find simple solutions to complexproblems. Alzheimers disease is the deteriorationof the brain cells (neurons), causingthem to die. Scientists can reverse thisby administrating stem cells into the brain to create new neurons, according to stem cell therapy supporters.

The Food and Drug Administration (FDA) is becoming the fiercest enemy of stem cell therapy. Recently, theagency sanctioned clinics that useunapproved therapies. They seizedvials of the smallpox vaccinefrom some clinics. The FDA attacked them for not having enough proof of their practices. Somehow, the FDA is right to think this way because of the public silence of the therapys developers. People need more information about the treatment and general development.

The medical gesture of health and procedures, as well asdiagnosis, is based on scientific and proven knowledge. Contrary to the aforementioned therapy, there is a long list of publishing in medicine. It is certain that there are professionals working on stem cells, but the mistrust is justified.

Whether the therapy is legit, trustworthy, or efficient, ithas a bright future. The need forlargeamounts of money to fund theproject is undeniable. Big relevant companies, such as CSL Behringare investing moneyto accelerate the growth of the therapy.

A new groundbreaking technique is being tested that couldbring brain dead patients back to life. People who cannot live without a machine. Specialists say it is impossible to reverse that kind of damage, but stem cells therapy offersa new alternative.

People notice how much power the stem cell industry has right now. Even if individualsdo not have the legal backing, they enjoy the advocacy of powerful individuals. It is sane to remember that the major scientific progress made in history was due to experimentation. Is better if it sounds impossible to accomplishbecause it can prove the human greatness to fight against something as natural as death.

Opinion News by Gian Torres Edited Jeanette Smith

Sources:

CBS NEWS:FDA cracks down on clinics selling unapproved stem cell therapies BioPharma:CSL adding scalable stem cell gene therapy tech in $91m Calimmune buy Wall Street Pit:Brain Dead Patients Could Be Brought Back to Life in Groundbreaking Stem Cell Therapy

Featured and Top Image Courtesy of Berkshire Community College Open Bioscience Image Librarys Flickr Page Creative Commons License

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Stem Cell Therapy and Its Revolutionary Purposes Guardian ... - Guardian Liberty Voice

Canadian clinics begin offering stem-cell treatments …

The arthritis in Maureen Munsies ankles was so intense until barely a year ago, she literally had to crawl on hands and knees to get upstairs.

The pain, she recalls now, took my breath away, and played havoc with the avid hikers favourite pastime.

In desperation, Munsie turned to a Toronto-area clinic that provides a treatment many experts consider still experimental, unproven and of questionable safety.

The 63-year-old says the stem cells she received at Regenervate Medical Injection Therapy 18 months ago were transformational, all but eliminating the debilitating soreness and even allowing her to hike Argentinas Patagonia mountains two months ago.

For me its been a life saver, Munsie says. Ive been able to do it all again I dont have any of that pain, at all.

Canadians drawn to the healing promise of stem cells have for years travelled outside the country to such places as Mexico, China or Arizona, taking part in a dubious form of medical tourism.

But Regenervate is one of a handful of clinics in Canada that have begun offering injections of stem cells, satisfying growing demand but raising questions about whether a medical idea with huge potential is ready for routine patient care.

Especially when those patients can pay thousands of dollars for the service.

Clinics in Ontario and Alberta are treating arthritis, joint injuries, disc problems and even skin conditions with stem cells typically taken from patients fat tissue or bone marrow.

The underlying idea is compelling: stem cells can differentiate or transform into many other types of cell, a unique quality that evidence suggests allows them to grow or regenerate tissue damaged by disease or injury.

Researchers including hundreds in Canada alone are examining stem-cell treatments for everything from ailing hearts to severed spinal cords.

With few exceptions, however, the concept is still being studied in the lab or in human trials; virtually none of the treatments have been definitively proven effective by science or approved by regulators like Health Canada.

The fact that Canadian clinics are now offering stem-cell treatments commercially is concerning on a number of levels, not least because of safety issues, says Ubaka Ogbogu, a health law professor at the University of Alberta.

Three U.S. women were blinded after receiving stem-cell injections in their eyes, while other American patients have developed bony masses or tumours at injection sites, Ogbogu said.

Stem cells have to be controlled to act exactly the way you want them to act, and thats why the research takes time, he said. It is simply wrong for these clinics to take a proof of concept and run with it.

Ogbogu says Health Canada must crack down on the burgeoning industry but says the regulator has so far been conspicuous by its inaction.

Other experts say the procedures provided here typically for joint pain are likely relatively safe, but still warn that care must be taken that the stem cells do not develop into the wrong type of tissue, or at the wrong place.

Alberta Health Services convened a workshop on the issue late last year, concluding there is an urgent need to develop a certification system for cell preparation and delivery to avoid spontaneous transformation of (stem cells) into unwanted tissue.

But one of the pioneers of the service in Canada says theres no empirical evidence that such growths can develop, and suggests the treatments only real risk as with any invasive procedure is infection.

Meanwhile, patients at Regenervate have enjoyed impressive outcomes after paying fees from $750 to $3,900, says Dr. Douglas Stoddard, the clinics medical director.

About 80 per cent report less pain, stiffness and weakness within a few months of getting their stem-cell injection, he said. His treatments efficacy, though, has not been tested in a randomized controlled trial, the gold-standard scientific study which would compare the injections to a sham or other treatment and identify any placebo effect.

I believe medical progress is not just limited to the laboratory and randomized double-blind trials, Stoddard said. A lot of progress starts in the clinic, dealing with patients You see something works, you see something has merit, and then its usually the scientists that seem to catch up later.

The Orthopedic Sport Institute in Collingwood, Ont., the Central Alberta Pain and Rehabilitation Institute and Cleveland Clinic in Toronto all advertise similar stem-cell treatments for orthopedic problems.

Edmontons Regen Clinic says it plans to start doing so this fall.

Ottawas Innovo says it also treats a range of back conditions with injections between the vertebrae, and uses stem cells to alleviate nerve damage.

Orthopedic Sport says its doctor focuses on FDA and Health Canada approved stem-cell injection therapy for patient care.

In fact, no treatment of the sort the clinics here provide has ever been authorized.

Health Canada says the vast majority of stem-cell therapies would constitute a drug and therefore need to be authorized after a clinical trial or new drug submission.

A number of stem-cell trials are underway, but only one treatment Prochymal has been approved, said department spokesman Eric Morrissette. Designed to combat graft-versus-host disease where bone marrow transplants for treating cancer essentially attack the patients body its unlike any of the services the stem-cell providers here offer.

But as the U.S. Food and Drug Administration aggressively pursues the hundreds of clinics in America, Health Canada says only that its committed to addressing complaints it receives.

It will take action based on the risk posed to the general public, said Morrissette, who encouraged people to pass on to the department information about possible non-compliant products.

Stoddard said the injections his clinics provide are made up of minimally manipulated tissue from patients own bodies and any attempt to crack down would be regulation for the sake of regulation.

But academic experts remain skeptical about the effectiveness of the treatments.

Scientific evidence suggests the injections may help alleviate joint pain temporarily, but probably just because of anti-inflammatory secretions from the cells not regeneration, said Dr. David Hart, an orthopedic surgery professor at the University of Calgary who headed the Alberta workshop.

Theres a need for understanding whats going on here and theres a need for regulation, he said.

Most of the clinics say they use a centrifuge to concentrate the stem cells after removing them from patients fat tissue or bone marrow. But its unclear if the clinics even know how many cells they are eventually injecting into patients, says Jeff Biernaskie, a stem-cell scientist at the University of Calgary.

Munsie, on the other hand, has no doubts about the value of her own treatment, even with a $3,000 price tag.

The procedure from extraction of fat tissue in her behind to the injection of cells into her ankles took barely over an hour.

Within three months, the retired massage therapist from north of Toronto says she could walk her dogs again. Last week, she was hiking near Banff.

Im a real believer in it, and the possibility of stem cells, says Munsie. I just think Wow, if we can heal with our own body, its pretty amazing.

(The story was modified July 6 to clarify lack of clinical-trial evidence for Regenervate procedures.)

tblackwell@nationalpost.com

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FDA cracks down on clinics selling unproven stem cell therapies – Gears Of Biz

The US Food and Drug Administration (FDA) yesterday targeted a booming national market for suspect medical treatments, announcing actions against clinics offering questionable stem-cell treatments for cancer and other diseases.

The FDA moved against California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage; StemImmune Inc of San Diego; and the US Stem Cell Clinic of Sunrise, Florida.

In what it termed as decisive action to protect patients, the FDA on Friday dispatched US marshals to the California clinics and seized close to 500 doses of smallpox vaccine supplied by StemImmune. The vaccine was to be mixed with stem cells taken from patients body fat, for direct injection into patients malignant tumors.

According to the FDAs statement issued Monday, this is an unapproved and potentially dangerous treatment for cancer.

Of the five vials of vaccine, one had been opened and was partially used, the FDA said.

According to the agency, the seizure of the smallpox vaccine was necessary to prevent the use of a potentially dangerous and unproven treatment.

The FDA said it would investigate how StemImmune Inc came to be in possession of the smallpox vaccine, which is not commercially available and is normally reserved for people who are at risk of exposure to smallpox, such as military personnel and healthcare workers.

Meanwhile, the FDA said in a press release, As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.

Speaking as a cancer survivour, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures, said FDA commissioner Scott Gottlieb, MD.

The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially wont allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.

The seizure comes after recent FDA inspections at StemImmune Inc and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients tumors.

Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.

Ive directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk, Gottlieb added. I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.

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FDA cracks down on clinics selling unproven stem cell therapies - Gears Of Biz

FDA to crack down on ‘unscrupulous’ stem cell clinics …

FILE -- The Sawgrass Medical Center, where the U.S. Stem Cell Clinic operates, in Sunrise, Fla., March 15, 2017. The Food and Drug Administration issued a warning letter to U.S. Stem Cell and announced a crackdown on other dangerous stem cell clinics, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field. (Scott McIntyre/The New York Times)

The U.S. Food and Drug Administration on Monday promised a nationwide crackdown on unscrupulous stem cell clinics, following years of reports that some clinics have offered lofty claims of potential medical benefits with scant, if any, medical evidence.

These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products, as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk, wrote FDA Commissioner Dr. Scott Gottlieb, who was appointed in May. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.

Gottliebs statement, published Monday on the FDAs website, highlighted a warning letter issued to one Florida stem cell clinic on Thursday and the direct seizure of products from another clinic in California on Friday. Gottlieb said the agency is aware of other cases where unproven stem cell treatments have clearly harmed patients, and he promised additional enforcement actions in the coming months.

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FDA to crack down on 'unscrupulous' stem cell clinics ...

FDA cracks down on clinics selling unapproved stem cell therapies – CBS News

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

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FDA cracks down on clinics selling unapproved stem cell therapies - CBS News

FDA cracks on clinics using unapproved stem cell treatments – Pulse Headlines

The U.S. Food and Drug Administration (FDA) said on Monday that it would take severe measures after it found that clinics around the country are selling unapproved and potentially dangerous stem cell treatments to patients with cancer and other hard diseases, according to a warning letter posted by the agency.

The crackdown was announced due to hundreds of clinics around the country selling unapproved stem cell therapies, but two of them were specifically pointed: the U.S. Stem Cell Clinic of Sunrise, Florida; and California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. In the last one, certain doctors carried out a surgery where they injected a smallpox vaccine intravenously and directly to the patients tumors.

Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies, the President of the International Society for Stem Cell Research, Hans Clevers, said in a statement. We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients.

On Monday, the FDA posted on its web page a warning letter sent last week to U.S. Stem Cell Clinic of Sunrise, Florida. In it, the agency condemned the selling of unapproved stem cells treatments, which doctors injected intravenously and directly into the patients spines. Previously, according to a report published by the New England Journal of Medicine, this Florida clinic was already linked with three women who ended up blind after they were subjected to a fat-stem cell treatment for macular degeneration.

However, this is just one of many other clinics around the country that the agency accused to use stem cells vaccines to treat different conditions, such as cancer, Parkinsons disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases.

Along with it, on the same Monday, the agency announced that last week it accused StemImmune Inc. of San Diego to purchase five live virus vaccine vials, previously designated to only those patients who were at high risk of smallpox. At the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the vaccines were later combined with stem cells extracted from patients fat and injected directly to patients tumors.

Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health, The FDA commissioner, Dr. Scott Gottlieb wrote in a statement. We have examples where some of these unproven treatments have clearly harmed patients.

Doctors might offerunapproved stem cells therapies, and people under high-risk diseases might accept them without having a second thought. This is why the FDA published a series of advice for safe before they choose an unproved and dangerous treatment instead of a secure and adequate therapy.

If you see a business thats making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of, said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota.

According to Turner, it is not easy for patients to either recognize which treatment would be good and beneficial for them, or which one would be totally dangerous.

Source: CNN

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FDA cracks on clinics using unapproved stem cell treatments - Pulse Headlines

Stem cell treatment potential in Canada – IMTJ

IMTJ	Stem cell treatment potential in Canada IMTJ Realising the potential for stem cell treatment, Canadian clinics target locals who may consider going to China, Mexico or the USA. Toronto stem cell clinic RegenerVate is targeting Canadians and US citizens for stem cell treatment. It offers a ...

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Stem cell treatment potential in Canada - IMTJ

Dozens of US clinics sell unproven stem cell therapies for heart failure – Fox News

Stem cell therapy isn't approved to treat heart failure in the U.S., but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the U.S. alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients' medical records and just one facility said it had a board certified cardiologist on staff.

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"We simply do not know anything about the quality of the treatment delivered at these centers," said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

"These centers are not regulated in any way," Hauptman said by email.

Almost 6 million Americans have heart failure, and it's one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the U.S. Food and Drug Administration.

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In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasn't involved in the study.

It's also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though there's no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patient's own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, "If you have a million dollars to spend we will set you up with weekly infusions."

Hauptman's team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, "If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you" and "We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us."

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients' cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

"This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain," said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasn't involved in the study.

"The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure," Sipp said by email.

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If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasn't involved in the study.

But it's impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

"Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris," Turner said. "Often one can only speculate."

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Broomfield’s Regenexx in merger with Iowa company – Longmont Times-Call

Dr. John Schultz gives an injection of bone marrow derived stem cells into the knee of patient Steve Brink from Washington state at the Regenexx offices in Broomfield June 12. (Paul Aiken / Staff Photographer)

Broomfield's Regenexx, a stem cell treatment network, has completed its merger with Des Moines, Iowa-based Harbor View Medical.

The company corporate headquarters will move to Des Moines as a result, with the company's medical headquarters remaining in Broomfield, according to spokeswoman Caroline Patterson.

Patterson said there would be no layoffs in Broomfield as a result of the merger.

Regenexx co-founder, Dr. Christopher Centeno, a pioneer in using stem cells to treat orthopedic injuries, will maintain his role as chief medical officer and Jason Hellickson will become CEO.

Regenexx treatments include injection of a patient's own stem cells and platelet-rich plasma (PRP) to encourage healing of tendons, joints and muscles.

"Most of what we currently call orthopedic surgery will, in the next 10-20 years, be in the dust bin of history," Centeno told the Daily Camera last month. "Thirty years from now, cutting people open and drilling holes will be considered barbaric."

Despite advances in research, critics say the safety and effectiveness of these regenerative treatments is largely unregulated and remains poorly understood.

A study by Mayo Clinic, whose results were published last year, noted that patients in a blind study, who had arthritis in both knees, saw benefits from the treatment, but that it wasn't clear why. Just one knee had actually been injected with the stem cells.

The stem cell treatments have generated controversy among some medical professionals because they cost thousands of dollars and have not been widely studied. Last year the U.S. Food and Drug Administration (FDA) held a series of scientific meetings examining how best to regulate and ensure the safety and efficacy of this approach.

The Mayo Clinic study, overseen by the FDA, concluded that the procedure it studied was safe to undergo, but it was not ready to recommend it for "routine arthritis care."

Still the use of stem cell treatments in everything from veterinary clinics to dermatology orthopedic practices is growing. Founded in 2005, Regenexx lists 48 clinics worldwide, including a new facility it opened in Mumbai this month.

Jerd Smith: 303-473-1332, smithj@dailycamera.com or twitter.com/jerd_smith

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Broomfield's Regenexx in merger with Iowa company - Longmont Times-Call