Sizing Up Sizzling FDA Warning Letter to Fat Stem Cell Clinic Stemgenex

Stemgenex

Do the hundreds of unproven fat stem cell clinics in the U.S. like Stemgenex have a tenable future without working with the FDA? It seems less certain now in 2018 than it did in 2017, and that’s a good thing in my view.

Stemgenex received an FDA warning letter yesterday that included a list of many troubling issues at the clinic. This warning letter just adds to difficult issues facing this clinic firm including a proposed class action patient lawsuit against it that that could get class status in the next few months.

Stemgenex

Stemgenex also had apparently considered targeting (via questionable approaches in my view) the websites of its critics a few years back including CIRM.

You can read the new FDA warning letter itself here. The warning outlines numerous problems according to the agency including both the use of an unapproved drug in the form of fat stem cells and apparent numerous deviations from standard clinical laboratory practices that are crucial for ensuring patient safety.

There’s also a remarkably strongly worded accompanying FDA press release (PR) on this enforcement action here. The PR’s title says a lot by itself, “FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk.” Note the use of the word “illegally.”

A quote in the PR from Commissioner Scott Gottlieb specifically mentions “bad actors” in this context too:

“The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products. This is putting patients’ health at risk. It’s also putting at risk the long-term viability of the industry and of effective products, when other operators are misleading consumers by marketing unproven therapies using claims of safety and benefit,” said FDA Commissioner Scott Gottlieb, M.D.”

What’s next for Stemgenex?

It would be a challenge for them to become entirely compliant in the short time they have to comply. They would have to not only change their laboratory practices, but more importantly stop using fat stem cells, which is the focus of their business model. Barring a surprising move to near complete compliance, will they be subject to an injunction or FDA suit? It’s also unclear how the patient lawsuit against them will proceed but it has substantial risk to the company.

FDA under Gottlieb steps up its game on clinics

In other fronts in the regulatory sphere on unproven clinics, recently the FDA issued a warning letter to American CryoStem and another one last year to U.S. Stem Cell Inc. (USRM), while about six months ago it sued in federal court for permanent injunctions against both USRM and California Stem Cell Treatment Center/Cell Surgical Network. It’s unclear to me why California Stem Cell Treatment Center/Cell Surgical Network did not receive a warning letter so far. The FDA also recalled a purported birth-related stem cell product from supplier Liveyon apparently due to contamination.

Overall, these events together mark a notable uptick in FDA action against unproven stem cell clinics since Gottlieb’s tenure began, which I see as a welcome sign. I hope it continues given the big scope of the unproven stem cell clinic industry. The FTC should continue to do more as well and state medical boards need to up their game to deal with this problem as well at the level of physicians.

2 Comments


  1. Being curious, I looked up Stemgenex on Clinicaltrials.gov. I hope that patients are not still going to that website in hopes that the treatments listed are approved by the government. Here’s what is posted. I’m not sure what an “observational trial” is. It would be nice if the website added a note to say that the clinic has received an FDA warning notice.
    1 Recruiting Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis StemGenex San Diego, California, United States
    2 Recruiting Outcomes Data of Adipose Stem Cells to Treat Chronic Obstructive Pulmonary Disease StemGenex San Diego, California, United States
    3 Recruiting Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis StemGenex San Diego, California, United States
    4 Active, not recruiting Outcomes Data of Adipose Stem Cells to Treat Parkinson’s Disease StemGenex San Diego, California, United States
    5 Active, not recruiting Outcomes Data of Adipose Stem Cells to Treat Multiple Sclerosis StemGenex San Diego, California, United States


    • clinicaltrials.gov is a great resource for those who know how to use it and understand the terms used. But this is not for most patients, who cannot tell the difference between approval to conduct a clinical trial with a drug and approval to market the drug.

      Some clinical trials are not even aimed at gaining marketing approval, such as those you cited from Stemgenex. An observational trial is simply done to see if there is a rationale for moving onto a controlled clinical trial with defined cohorts. Observational trials are a collection of n=1 trials with no controls. These are not results the FDA can assess for marketing approval.

      But if patients do not understand this, they may think that the Stemgenex trials show that the FDA have approved…something…and if itˈs in a trial there must be some value in the “drug”. This is of course wrong and clinicaltrials.gov makes no implications on success or failure (an MIT study reported that only 14% of all drugs in clinical trials eventually gain marketing approval).

      One could use this type of trial to pull the wool over the patientsˈ eyes by using the data manipulatively to claim e.g. improvement in a bunch of patients but this is scientifically unsound as there are no untreated controls. In this observational framework, the only hard evidence of efficacy would be some validated biological or physiological score, independent of the patientˈs opinion, such as motor evaluation for Parkinsonˈs disease (PD).

      I checked the primary outcome measure for the Stemgenex PD trial hoping to see such a metric, but the aim of the study is only “to evaluate quality of life (QoL) changes in individuals with PD”, which means only patientˈs opinion will be recorded and no physiological endpoints. So the Stemgenex trial can report that so and so many patients has an improved QoL but cannot report that there was an improvement in disease progression or physical capacity or how long their new QoL will hold out – probably only until the adipose next stem cell injection.

      But maybe Iˈm being unfair and Stemgenex are planning to use the observational trials to run a series of controlled, randomized, multicenter, interventional trials with patient opinion independent outcome measures, with the aim of gaining FDA marketing approval for adipose derived stem cells for PD.

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