Archive for the ‘Stem Cell Clinics’ Category

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

Stem Cell Clinics | Posted by admin
Aug 29 2017

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

Stem Cell Clinics | Posted by admin
Aug 29 2017

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

Stem Cell Clinics | Posted by admin
Aug 20 2017

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 Clinics | Posted by admin
Jul 30 2017

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

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

Stem Cell Clinics | Posted by admin
Jul 12 2017

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

North Central Texas Stem Cell Clinics in conjunction …

Stem Cell Clinics | Posted by admin
Jul 09 2017

Our Regenerative Cell Treatment is a revolutionary breakthrough treatment option for people suffering from inflammation, reduced mobility, sports injuries, tissue and ligament damage, or chronic pain. Regenerative Cell Therapy is an injectable regenerative tissue matrix solution, that often times leaves the patient feeling relief after only ONE treatment. This cutting edge treatment takes the best components from all the current non-invasive treatment options and puts them into one.

Why should you use Regenerative Cellular Medicine? It works with the bodys natural ability to heal itself. Unlike treatments that simply address the symptoms, regenerative cell therapy actually promotes the natural process of repair in the body, assisting in restoring degenerated tissue.

Our treatment plans are comprehensive. Not only will we provide you with the most cutting-edge treatment options, but we will also assist you through rehabilitation. Following the custom program created for your specific needs will thoroughly increase the effectiveness.Typically, there is no little to no downtime from cellular therapy.

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Private clinics’ peddling of unproven stem cell treatments is unsafe and unethical – Medical Xpress

Stem Cell Clinics | Posted by admin
Jul 08 2017

July 7, 2017 by Megan Munsie And John Rasko, The Conversation Stem cells have saved thousands of lives thanks to their applications in cancer treatments. Many other uses peddled by private clinics are without evidence. Credit: http://www.shutterstock.com

Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures aren't sold treatments with limited efficacy and unknown safety.

So what's on offer?

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

Rather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of "improvement". In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an "opportunity cost" because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental "stem cell" treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

What's approved?

At present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Often dismissed by for-profit clinics as "red tape" hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

So what can be done?

Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

For more information on recognised stem cell treatments visit the National Stem Cell Foundation of Australia and Stem Cells Australia, Choice Australia, EuroStemCell, International Society for Stem Cell Research, and International Society for Cellular Therapy.

Explore further: Medical tourism in spotlight as experts call for tighter regulation

This article was originally published on The Conversation. Read the original article.

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Private clinics' peddling of unproven stem cell treatments is unsafe and unethical - Medical Xpress

Stem Cell Therapy – Cendant Cellular Therapies – Denver …

Stem Cell Clinics | Posted by admin
Nov 30 2016

Harnessing stem cells to cure disease is the hottest topic in joint injury, knee pain and arthritis treatment today. By using the adult stem cells found in our own bodies, we can amplify and speed up the natural healing process as well as grow new bone and cartilage to rebuild joints without the need for artificial replacements.

At Cendant Stem Cell Centerin Denver and our new Milwaukee Wisconsin clinic, we provide our patients with the most recent technological advancements available for treating orthopedic injuries and conditions. Our Stem Cell therapy procedureprovides treatment to repair damaged cartilage, restore function, eliminate hip, shoulder, back and knee pain and to prevent further joint destruction.

The patients adipose (fat) derived Stem Cells and/or bone marrow derived Stem Cells are injected alongwith Platelet Rich Plasma into the joint capsule space. These components are put on top of an Extracellular Fiber Matrixwhich is injected into the joint capsule before the introduction of Stem Cells. This FDA approved fiberis a major advancement in the Stem Cell procedure which gives Stem Cells a structure to bind and growupon inside the joint space. The technology allows us to treat older patients and patients with more aggressive joint disease who are facing replacement surgery or suffering from chronic pain.

The Stem Cell procedureis virtually painless, takes 3 hours and is performed under local anesthesia. It requires little to no downtime and is effective, fast and safe. Please visit our Video Testimonials page to hear from our patients and why they choose our Denver and Milwaukee stem cell clinics for their medical needs.

Ourunique approach to stem cell therapy does not offer a single franchised solution. Cendants multiple technologies provide case-driven stem cell treatment options to address individual patient needs.

Medical researchers are reporting remarkable results using platelet rich plasma and stem cellsin the treatment of common injuries, including:

What should patients expect after Stem Cell Therapy?

The noticeable regeneration of the joint tissue and cartilage typically starts to occur within 3 weeks. Most of our patients report asubstantialreduction in pain and improved function within 4-6 weeksafter treatment. Many report total pain elimination within 10-12 weeks. Within 3-5 daysafter the procedure, most patients can return to work and resume normal daily activities. Patients cannot start stressful activity or begin strenuous exercise for six weeks. Returning to stressful activity before six weeks may result in incomplete healing of the treated tissue.

Is this therapy safe?

Yes. Autologous PRP therapy and Stem Cell therapy has been used for over 10 years in surgical and orthopedic procedures. There are many research articles published on the safety of these therapies. Because a patients own blood and cells are used, there is little risk of a transmissible infection, no side effects and a very low risk of allergic reaction.

How many treatments are required?

We treat most patients aggressively upon the first visit with a mix of PRP, Extracellular Fiber Matrix and Stem Cells which all work together to create yourregenerative injection. Most patients need only 1 treatment but you could potentially have a follow up pure PRP injection which is thought of as a booster shot, the primary function of which is to stimulate continual stem cell growth.

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Stem Cell Clinics Questions to Ask – National Multiple …

Stem Cell Clinics | Posted by admin
Sep 23 2016

Exciting progress is being made through innovative and carefully conducted research related to the potential of many types of stem cells for slowing MS disease activity and for repairing damage to the nervous system.

At present, there are no approved stem cell therapies for MS. There are different types of stem cells and the effects of receiving them depend on additional factors, including the specific procedures used to prepare and administer them, and biological conditions in the person to whom they are given. Stem cell therapy is still in the experimental stage, so its important for people to have the best available information to understand this exciting area of research and make decisions related to this complex issue.

In the U.S. and in other places around the world, for-profit stem cell clinics are appearing in increasing numbers. These clinics claim to have treated people with MS and people with many other disorders with stem cells. However, these clinics are unregulated and none have provided medical evidence that their treatments work or are safe. A recent study published in June 2016 confirmed that many different types of unproven stem cell treatments are being offered in these clinics. The study highlighted concerns for the safety of people who undergo these treatments, emphasized the need for better oversight and raised ethical issues and regulatory concerns related to marketing unproven treatments for a range of health conditions.

The papers findings support the need for stem cell therapy to be explored in the context of carefully conducted clinical trials that can determine what the optimal cells, delivery methods, safety and actual effectiveness of cell therapies might be for people with MS. For more details about this study:

Many experts in the MS community have expressed concern that:

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CIRM Alpha Stem Cell Clinic – UCSD Stem Cell Program

Stem Cell Clinics | Posted by admin
Sep 18 2016

Mission

The mission of the UC San Diego CIRM Alpha Stem Cell Clinic is to accelerate the design of innovative stem cell research to advance the testing and delivery of safe and effective stem cell-based therapies in regenerative medicine.

For more information, please visit the CIRM Alpha Stem Cell Clinic page on the UC San Diego Health website.

We are one of three alpha clinics in a network designated by theCalifornia Institute for Regenerative Medicine (CIRM), the states stem cell agency. The UC San Diego CIRM Alpha Stem Cell Clinic is the cell therapy arm ofSanford Stem Cell Clinical Center at UC San Diego Health.We specialize in early phase, first-in-human trials.

The Alpha Stem Cell Clinics are intended to create the long-term, networked infrastructure needed to launch and conduct numerous, extensive clinical trials of stem cell-based drugs and therapies in humans, including those developed by independent California-based investigators and companies. These trials are requisite before any new drug or treatment can be approved for clinical use.

The clinics will emphasize public education to raise awareness and understanding of stem cell science. This will combat stem cell tourism and the marketing of unproven, unregulated and potentially dangerous therapies. The clinics will also help establish sustainable business models for future, approved stem cell treatments.

See how we're improving the consent process by deploying enhanced electronic consent tablets.

An Overview of the UC San Diego CIRM Alpha Stem Cell Clinic

alphastemcellclinic@ucsd.edu

1-844-317-STEM (7836)

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CIRM Alpha Stem Cell Clinic - UCSD Stem Cell Program