Monthly Archives: July 2017

Clinics that offer unproven stem-cell therapies have begun to use a website run by the National Institutes of Health (NIH) to recruit paying patient-customers, according to an article published last week in the journal Regenerative Medicine by Leigh Turner, a bioethicist at the University of Minnesota.

The website is ClinicalTrials.gov, which is a registry of public and private clinical trials (research that uses human subjects) being conducted around the world. People with a chronic illness sometimes use the site to see if there is a clinical trial that they might qualify for, usually with the hope that the new treatment being tested might improve their medical condition and their quality of life.

Most researchers who list their studies on ClinicalTrials.gov do not charge patients to participate, and if they do, it is only a nominal amount and after first receiving approval from the Food and Drug Administration (FDA) to do so.

Turner has found, however, that clinics selling dubious stem-cell treatments are now listing equally dubious clinical trials on the NIH website studies for which they are charging patients thousands of dollars.

Often, there is no hint on ClinicalTrials.gov that these are pay-to-participate stem-cell studies. Patients discover that only when they call the clinic to ask about enrolling in the trial.

Most patients are also unaware that those pay-to-participate studies are highly questionable, with inadequate peer-reviewed preclinical research (to make sure that there is substantial evidence that the treatment is safe) and inappropriate study-designs (such as not randomizing patients to different treatment groups and not using placebos or sham procedures to control for placebo effects).

The clinics are basically trying to take advantage of the perceived legitimacy and credibility of the website, said Turner in an interview with MinnPost. They want to suggest that if their studies are on this site, then they must be legitimate.

The problem is that anybody can sit at his computer, enter pretty much anything, press submit, and get on ClinicalTrials.gov, because the screening is inadequate, he added.

Earlier this year, NIH made its disclaimer regarding ClinicalTrials.gov more prominent. Patients who click on the site now see a statement across the top of the sites home page that says, Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted health care professional before volunteering for a study.

That change was made after an article published in March in the New England Journal of Medicine described how three women in their 70s and 80s had developed severe vision loss in one case, total blindness immediately after undergoing an unapproved stem-cell procedure for age-related macular degeneration (AMD) at a Florida clinic.

At least one of the women said she had learned about the procedure after reading about it in a study description posted on ClinicalTrials.gov. She and the other women each paid $5,000 to the clinic for the treatment.

As Ive written here before, only a fewstem-cell therapieshave been shown through clinical research to be safe and effective for treating medical conditions, mostly cancer and blood and immune disorders. Yet that hasnt stopped hundreds of clinics across the United States including here in Minnesota from marketing unapproved stem-cell therapies for a long and widely diverse list of other conditions, including (in addition to AMD) aging skin, sports injuries, sexual dysfunction, HIV/AIDS, autism, dementia, chronic obstructive pulmonary disease (COPD), Parkinsons disease and multiple sclerosis.

In a study published last year, Turner identified 351 companies in the United States that are engaging in direct-to-consumer advertising of stem-cell therapies at 570 individual clinics across the country. Most of these companies marketautologous stem cells, which are derived from cells collected from the patients body (often from fat tissue) and then injected back into the patient.

Leigh Turner

In his current paper, Turner found that such companies had successfully registered seven patient-sponsored, patient-funded, or self-funded autologous stem-cell studies on ClinicalTrials.gov. These are all studies for which the patient must pay $6,000 or more in order to participate. Another 11 studies listed on the site make no mention not even through coded terms like patient-sponsored that a fee will be charged. The patients learn that they must give the clinic money only when they seek out further information from the company or clinic sponsoring the trial.

These are junk studies that are nothing more than marketing devices, said Turner.

People can spend a lot of money not only for no real benefit, but no real prospect of benefit, for the treatment was never going to work, he added.

In some cases, patients undergoing an unproven stem-cell treatment will forgo therapies that research has proven to be effective at managing their chronic disease, he added.

And then there is the real possibility that the dubious stem-cell studies will lead directly to physical harm, as demonstrated by the cases of the Florida women.

Indeed, in another Florida case, a cardiologist lost his medical license after a patient died in 2012 while undergoing an unproven stem-cell procedure at his clinic a procedure for which the patient reportedly paid $54,000.

Turner applauds the placing of a more prominent disclaimer on the ClinicalTrials.gov website, but he believes that action alone is insufficient to protect the public from unscrupulous stem-cell clinics. Federal officials need to vet all studies before they go up on the site, he says, to ensure each one meets certain basic requirements such as getting FDA approval before charging patients to participate.

The cost of such vetting to the government would be minimal compared to the benefit it would bring vulnerable patients.

ClinicalTrials.gov has a lot of value and a lot of good intentions behind it, but it turns out that its really easy to take advantage of it and just repurpose it and abuse it as a marketing platform, Turner said.

Unless the site is more closely supervised, he added, There are going to be more people spending money for interventions that arent going to help them in any way, and there will be more people harmed.

FMI: You'll find Turner's paper on Regenerative Medicines website.

Go here to see the original:
Stem-cell clinics are using a federal website as a marketing tool for unproven treatments, U of M bioethicist says - MinnPost

Stem cell therapy isnt approved to treat heart failure in the US, 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 US 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.

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 its 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 US Food and Drug Administration.

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 wasnt involved in the study.

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

Even though theres 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 patients 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.

Hauptmans 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 dont 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 wasnt 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.

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 wasnt involved in the study.

But its 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.

Read more:
More than 60 US clinics have sold unproven stem cell therapies for heart failure - New York Post