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.
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:
- “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.
- What was the FDA’s response to U.S. Stem Cell when it tried to impede the investigation?
- 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?
- 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.
- Please explain the process by which a clinical trial goes through before placement on the ClinicalTrials.gov website.
- 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?
- 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.
HIT PIECE!
“What was the FDA’s response to U.S. Stem Cell when it tried to impede the investigation?”
Perfect example. They didn’t impede Jack. Too bad Amerika is too stoopid to figure out they are
being screwed in every way. Wake the {F} up!
Read thishttps://www.opensecrets.org/members-of-congress/industries?cid=N00001758&cycle=CAREER
Hahahaha! This a joke right? These questions do not need to be answered! It was already settled in a court of law with the ‘already going blind ladies…
Usrm can operate because as of now they do not violate any law. Beside fda will accept and admit benefits.. & they will be approved. USRM agreed to do the biggest trails if they get help paying for it! (THE COST FOR TRIALS IS INFEASABLE FOR SMALL COMPANIES!) — HMMMM I WONDER WHY???(BIG PHARMA!!)
USRM Myocell product will be approved and it will be a 10bn industry JUST FOR THE USE OF MYOCELL
You cannot deny the obvious, stem cells work, big pharma (pill companies) are scared, and fda is on big pharmas payroll along with Sen. Grassley…
Exactly. FDA already answered in article that enforcement against all regens would be stayed for 3 years.
Clearly pharma has this old senator in their pocket.
Think about it…why is a Senator from Iowa bringing up questions about procedures performed over 3 years ago in Florida? And doing so, the EXACT day and time of release of yearly financials? No reason other than to hurt stock and help pharma.
@John, to clarify, “stayed for 3 years” isn’t really what they said.
There are broadly speaking 36 months for sponsors to adjust, but the agency has the discretion to take action at any time (e.g. without waiting 3 years) if it views particular practices as presenting a major risk or if there is some other compelling reason.
Note that after it issued the guidances, the FDA soon thereafter sent a warning letter to this regen. med company just a couple months ago: https://ipscell.com/2018/01/fda-issues-1st-stem-cell-warning-letter-2018-american-cryostem.
I’m not sure what sparked that letter, but my point is that it clearly shows there is no universal 3-year waiting period.
As to one of your other points, I do agree the timing of Grassley’s letter is really odd even if I think his questions are good ones. I don’t believe in the big pharma conspiracy theory though.
Paul
I has stem cells injected into my penis and now it’s super big and big Pharma can suck it…..stem cells are the future.
Sen. Grassley’s questions are remarkably astute, and I personally want to know the answers. The FDA is NOT a boogyman trying to steal your cells. The job of the FDA is to make sure that treatments are safe. Clearly, putting fat cells into eyes is not safe. I think that stronger oversight of clinicaltrials.gov…or the creation of a site that lists only trials that are following FDA regulations…would be a great first step that our government can do about reducing the impact of these predatory clinics.
I just received 3 google alerts in the past 3 days about new “umbilical cord stem cell” clinics opening around the country. The FDA is way over its head on this one. They can’t stop it just like they can’t stop all the spurious “medical” marijuana claims either.
THE AMERICAN PEOPLE DESERVE BETTER! The situation in which USRM finds itself reminds me of the demise of the Tucker automobile. Read the quote below replacing “Tucker” with “USRM”, the “Big Three” with “Big Pharma”, “new car designs” with “new medical treatments”, and “Senator Ferguson” with “Senator Grassley”.
From WIKI:
Quote:
After World War II, the public was ready for totally new car designs, but the Big Three Detroit automakers had not developed any new models since 1941. This provided great opportunities for new, small automakers, which could develop new cars more rapidly than the huge legacy automakers. The Tucker 48 (named after its model year) is an automobile conceived by Preston Tucker and briefly produced in Chicago in 1948. Only 51 cars were made before the company ceased operations on March 3, 1949, due to negative publicity initiated by the news media, a Securities and Exchange Commission investigation and a heavily publicized stock fraud trial (in which the allegations were proven baseless and led to a full acquittal). Speculation exists that the Big Three automakers and Michigan Senator Homer S. Ferguson also had a role in the Tucker Corporation’s demise. Similarly, Tucker had suffered another setback when his bids to obtain two steel mills to provide raw materials for his cars were rejected by the War Assets Administration under a shroud of questionable politics
IMO The American People are not as naive as they were in 1949, and will not tolerate such BS.
As our Founding Father’s shouted “DON”T TREAD ON ME!”
I am glad that Grassley is investigating this. I was visually impaired but stable. I feel that I was wronged by one of these clinics in Margate FL and now have much less vision after their procedure.
It needs to be better regulated…
USRM is not in Margate FL. They haven’t done these procedures in years.
He seems to be referring to some other, different place that’s also in S. Florida.
Sen. Grassley is paid by big pharma and an absolute goon. I appreciate USRM getting coverage but I am not blind to hidden agendas. Don’t buy into this, they want to keep real treatments that work suppressed. These “blind woman” were already going blind and tried an experimental treatment that didn’t work. How many drug studies have had similar results or worse? How many thousands of deaths each year can be linked to big pharma? Exactly, keep pushing for stem cells. It’s the safe and high road.
Nice hit piece to come out on the date of USRM financials.
Those alleged blinded ladies were suffering from macular degeneration. ..i.e. going blind already. Those suits were settled back in 2015 and USRM discontinued in 2015 any treatments related to eye.
Since then USRM has become a leader in products, treatments, services and banking of stem cells.
@john, How is this a “hit piece”? I don’t know why Grassley got interested in this topic in the 1st place and why he put out his announcement yesterday.
His article is filled with misinformation. He has it all over his website that he is paid by pharmaceutical and insurance lobbies. This blind lady nonsense has been over for years. Every single quarterly report they pull this old news out to harm USRM stock. Such manipulation
The FDA is a https://foreignpolicymag.files.wordpress.com/2013/11/2403148199_1284b0edbc_o21.jpg?w=625&h=450&crop=0,0,0,33