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TOPIC: Medicine´s Wild West- SVF clinics

Medicine´s Wild West- SVF clinics 11 Sep 2015 08:04 #5210

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An article was published in yesterday´s issue of "The New England Journal of Medicine", one of the highly respected (and conservative) medical publications...

Should interest us also-

Medicine’s Wild West — Unlicensed Stem-Cell Clinics in the United States
Hermes Taylor-Weiner, Ph.D., and Joshua Graff Zivin, Ph.D.

In recent decades, there has been tremendous hope that stem-cell–based technologies would introduce a new era of regenerative medicine, revolutionizing the treatment of disease. These hopes have been stoked by reports that often emphasize promising findings without adequately acknowledging the many remaining challenges. Although stem-cell therapy may hold great potential, the field is less advanced than the public has been led to believe. Stem-cell clinics in the United States and abroad have capitalized on this confusion by selling treatments that are not approved by the Food and Drug Administration (FDA), supported by clinical studies, or covered by insurers.
The FDA has approved few treatments involving stem cells. The approved therapies use hematopoietic stem cells to treat diseases of the blood and immune system. But the majority of therapies offered by stem-cell clinics use adipose-derived stem cells packaged as a product called stromal vascular fraction (SVF). Procedures using SVF have become increasingly popular because of the relative ease of acquiring the cells. To produce SVF, clinics collect liposuction aspirate from a patient, separate the cells from the surrounding fat tissue, and administer the isolated cells back to the patient intravenously or by injection into the tissue to be treated. The stem cells found in SVF are multipotent, and proponents postulate that they may regenerate injured tissue or alter the immune system's inflammatory response. Although the FDA has not determined that SVF is safe or effective in treating any disease, U.S. clinics sell SVF-based procedures to patients with myriad conditions — from benign conditions such as hair loss to chronic and life-threatening diseases such as heart failure, muscular dystrophy, and Parkinson's disease.
These clinics neither claim their treatments are effective nor explicitly state that they're unfounded. Their websites frame their work as experimental — although none of the clinics are conducting FDA-approved clinical trials — and emphasize the potential regenerative capabilities of stem cells. Their language is intentionally imprecise and exploits the vulnerability of patients with debilitating diseases.
Since insurers don't cover unapproved stem-cell treatments, patients pay out of pocket for procedures that cost anywhere from $5,000 to $50,000.1 According to the FDA, the procedures may cause complications including infections, emboli, and toxic effects of anesthesia. Although the complication rate for the liposuction procedure is low (0.7%),2 the risks posed by SVF transplantation are largely unknown. Apart from directly harming patients, the activities of unlicensed clinics could hinder advances in the stem-cell field, if a tragedy resulting from unapproved treatment makes the public and regulators suspicious of stem-cell technologies in general.
Because FDA guidelines are ambiguous, stem-cell clinics have in effect been operating without regulation. The FDA classifies biologic products as either 351 products, such as cells that have been grown in culture or have undergone genetic manipulation, which are subject to strict regulatory oversight and cannot be used in patients without approval, or 361 products, such as vascular grafts, tendons, and semen, which can be used by licensed physicians as part of the “practice of medicine.” The latter products must be “minimally manipulated”; they must be for homologous use, meaning the tissue must perform similar functions before and after transplantation; they may not be combined with other substances besides water, crystalloids (usually salts), and preserving agents; and they must be implanted into the patient from whom the tissue was taken.3
Unfortunately, the definition of a 361 product is too vague to deter clinics from offering unapproved stem-cell treatments. For example, t

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Medicine´s Wild West- SVF clinics 21 Sep 2015 07:37 #5240

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Knoepfler also wrote an article on the subject, which caused a lot of discussion on his site...

Link to article

Predatory stem cell clinics are winning the war; what can we do?
Posted on September 16, 2015
For years I have been working to educate the community about the predatory stem cell clinics out there. These clinics prey on vulnerable patients and their families. The clinics use hope as a marketing tool.
A weapon.
As the number of such clinics has mushroomed in the US and elsewhere the risk to both patients and to the larger stem cell community proportionately rises too. We are in a situation today where the dangers from such clinics have never been higher.
They are making millions in profits with little-to-no accountability. Their therapies don’t have to work or even be proven safe. It’s odd because many consumers seem to expect more from non-health-related businesses such as McDonald’s or computer companies than from stem cell clinics.
Thousands of patients just in the US alone are regularly being subjected to experimental, non-FDA approved interventions. They are spending millions of dollars and being put at substantial risk.
Many patients are desperately looking for hope so they are very driven to find something that may help and are often willing to take unknown risks.
Some of us in the stem cell community are working to try to make some positive impact in this area. I believe we are making a difference, but overall the dubious stem cell clinics are winning the war.
Why are the clinics prevailing so far?
In part it is because they’ve been very smart about how they do business.
For instance, they do PR like pros, they manipulate some members of the media to almost in essence work as their spokespeople, they use social media to great effect, and they’ve won over some powerful allies in the form of certain patient advocates who have become in effect stem cell clinic advocates.
An illustration of the cleverness of the clinics is their move to take advantage of Clinicaltrials.gov to list their non-traditional, profit-driven business as if it were real clinical trials. They even go so far as to say that just because their work is listed in that database that their offerings are FDA-approved. They aren’t.
The stem cell clinics are also winning because the FDA has been so passive and ineffective, particularly during the last two years. Further in the past the FDA and more specifically the CBER division within the FDA that is tasked with dealing with stem cells took steps to regulate the stem cell clinic industry through actions such as warning letters. In contrast, lately CBER hasn’t done anything (at least apparent in the public domain and via FOIAs I’ve submitted) on the stem cell clinic problem.
This apparent regulatory passivity couldn’t come at a worse time either as the stem cell clinics proliferate like crazy in the US. There’s certainly a connection there. Less regulatory action = more dangerous clinics. It’s frustrating because CBER of course remains very active with the good citizens of the stem cell world such as those in academia and legit biotechs with appropriately high expectations for them.
Hello, CBER, are you home? Are you paying attention? Patients need to be protected.
I’ve tried talking with the FDA to get at the root of the stem cell clinic problem, but things remain nebulous. Are they afraid of being sued? Just too slow? Don’t have the budget? Maybe part of the problem is the leadership transition at the FDA where there hasn’t been a commissioner…but I think that’s only part of the story.
The FDA took a healthy step last year in issuing draft guidance (see my interview here with the FDA on the draft guidance) to regulate fat stem cell products that are almost certainly biological drugs requiring approval, but that’s been about it and those draft guidances have not been finalized. Until finalized, the draft guidances have no teeth. Meanwhile the fat stem cell clinics and others that sell unapproved stem cell biologics of various kinds such as amniotics, take advantage of this gray area to milk patients for millions of dollars all the while putting such patients at risk. The clinics are literally laughing at the FDA all the way to the bank.
Why should you care about this as a stem cell researcher, patient advocate, or other interested party? As has happened in the past, people are going to get hurt or killed at these clinics, and not only is that a tragedy unto itself, but also it will reflect badly on the whole stem cell arena. This magnifies the negative impact.

The unchecked stem cell clinic industry also has other negative effects such as muddying the waters for patients over just what is (and what isn’t) a legit stem cell therapy and research. We are also seeing some at academic institutions starting to give in to temptation and work with the dubious clinics too probably for the big bucks involved. In short, the war isn’t going well and the risks are growing.
So what do to?
We need to push the FDA to act more consistently, quickly, and forcefully on this problem. Maybe they think they are acting on it, but from my view it seems to be in slow motion. A recent poll on my blog indicates a larger sense within the stem cell community that the FDA isn’t being effective on stem cell clinics. And by my own calculations, the number of stem cell clinics in the US alone is skyrocketing. The FDA doesn’t have much time.
If more patients are injured or even die after getting questionable stem cell therapies, in a sense the FDA will bear part of the blame because of their ineffectiveness.
We also need organizations to step up to the plate and confront the clinics as well. When individuals such as myself and others including Leigh Turner and Doug Sipp do this, we have had some positive impact, but at great risk to ourselves. It is literally dangerous for us. I have been threatened with litigation and literally threatened to be attacked or killed.
Educational efforts can also be helpful and that is a major mission of this blog.
In the absence of timely FDA action, an out of control stem cell free market is churning. In January of this year I called it a “wild west” of medicine. It really feels that way. There’s demand so there will be supply. Something fundamental needs to change or the war is over and patients lose out, as does the stem cell field.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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