August 11, 2020

The Niche

Knoepfler lab stem cell blog

Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months ago.

Some of the cases of lost vision reportedly were documented by independent physicians including Dr. Thomas Albini. In 2017, the FDA issued a warning letter to USRM’s business U.S. Stem Cell Clinic addressed to its leader Kristin Comella. One possible cause of the vision loss is that the injected fat stem cells caused scar tissue to form in the eye that then damaged the retina.  You can see published images of the damaged retinas below.

stem cells eyes
Kuriyan, et al. 2017 NEJM Figure 2A showing patient with severely damaged eyes leading to loss of sight.

Since then, however, as far as I can tell USRM is still operating as a stem cell clinic and even is training others to also do unproven, for-profit stem cell “treatments.” These now apparently include attempts at male enhancement via penis injections of stem cells.

So what’s the current situation?

Are wheels turning at the FDA behind the scenes on USRM for additional potential oversight steps or is the warning letter the full extent of the action it will take in this situation?

Apparently, observers of stem cell clinics like me aren’t the only ones wondering and asking questions. Now Senator Chuck Grassley of Iowa has directly addressed this situation with a press release and a strongly worded letter to regulators including the head of HHS as well as FDA Commissioner Scott Gottlieb.

The letter asks 7 very logical questions and I hope the FDA/HHS will address them soon:

  1. “Has the FDA completed its investigation into U.S. Stem Cell and any related entities? If so, please provide a copy of the final report.
  2. What was the FDA’s response to U.S. Stem Cell when it tried to impede the investigation?
  3. Has the FDA referred U.S. Stem Cell and any of its employees to the Justice Department for potential prosecution? If so, when did that referral take place?
  4. It appears that the listing of a trial on ClinicalTrials.gov has created for some the impression that a trial is government-approved. The website has since posted disclaimers to stress that “[l]isting a study does not mean it has been evaluated by the U.S. Federal Government.” Please explain what benefits are presented by the website that outweigh the risk that patients will still incorrectly assume the trials are more credible because they are listed on a government website.
  5. Please explain the process by which a clinical trial goes through before placement on the ClinicalTrials.gov website.
  6. What steps have been taken to ensure that the trials listed on ClinicalTrials.gov are actually trials and not fee-for-service treatments or mere advertisements? What precautions are taken to educate potential research participants that the listed “trials” may not be an approved clinical trial?
  7. In what specific ways did U.S. Stem Cell Clinic fail to meet federal regulations? What plan did they implement to correct these deviations? Were they permitted to continue conducting treatments in the interim, and are they permitted to conduct treatments still?”

Meanwhile, USRM is just one of hundreds of clinics in the U.S. operating without FDA approval and without good, controlled science to back up what they are doing.

There is also additional potential evidence of other patients having been harmed as well at other clinics including one other woman who received fat stem cells into her eyes that allegedly caused blindness, an offering sold by a Georgia clinic that is part of Cell Surgical Network, an adverse event mentioned in a 2017 FDA inspection report.

This alleged fat stem cell injection into both eyes leading to lost vision sounds eerily similar to what is claimed happened at U.S. Stem Cell Clinic too. The Cell Surgical Network-related alleged vision loss situation will be the subject of an upcoming post soon.

Across the U.S. as a whole, who knows where else the various stem cell clinics are injecting unproven stem cells every day into vulnerable people with lord only knows what consequences and how many millions of dollars consumers may be wasting on these things even if they aren’t physically harmed. In my opinion, the FDA really needs to step up quickly to address this situation across the U.S. overall with more concrete actions than what they’ve already taken.

Grassley has asked the FDA and HHS to respond in writing to his 7 questions by April 27.

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