Federal Government Files Lawsuit Against 'Stem Cell' Clinics | Orthopedics This Week
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Federal Government Files Lawsuit Against ‘Stem Cell’ Clinics

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A lawsuit and a warning letter are just two actions of many that the federal government is using in its battle against so-called ”stem cell” clinics across the country.

The Federal Trade Commission (FTC) and the State of Georgia together are suing Canton, Georgia-based Stem Cell Institute of America and its co-founders. The lawsuit names the following as defendants: Steven D. Peyroux; Brent J. Detelich; Regenerative Medicine Institute of America, LLC doing business as Stem Cell Institute of America, LLC; Physicians Business Solutions, LLC; and Superior Healthcare, LLC.

The lawsuit alleges that the defendants made false or unsubstantiated efficacy claims about stem cell therapy effectiveness in treating arthritis, joint pain, and a range of other orthopedic conditions. The lawsuit also asserts that the defendants made false claims that the regenerative medicine compliance training program had FTC and U.S. Food and Drug Administration (FDA) approval. Furthermore, the lawsuit claims that the defendants “intentionally targeted elderly and disabled consumers.”

Acting Director of the Bureau of Consumer Protection Samuel Levine commented, “These defendants advertised expensive stem cell injections with baseless pain-relief claims and provided marketing materials and training to chiropractors to do the same.”

Levine continued, “With our partner, the Georgia Attorney General, we aim to ensure they can’t keep preying on older adults and others who need real medical help.”

In a separate action, the FDA issued a warning letter to Sandy, Utah-based Utah Cord Bank LLC doing business as Utah Cell Bank and FIOR Bioscience LLC. The Utah businesses operate from the same location.

The Utah clinic manufactures human umbilical cord blood, umbilical cord, and amniotic membrane derived cellular products for allogeneic use. According to the warning letter, the products are then distributed to health care professionals and medical facilities and are intended to be injected.

After conducting an inspection, the FDA issued the warning letter documenting 14 alleged deviations from applicable current good manufacturing practice and current good tissue practice requirements. The letter calls on the clinic to come into “compliance with all the applicable requirements of the federal regulations.” The letter further warns that if the violations are not adequately addressed, there may be regulatory action.


5 thoughts on “Federal Government Files Lawsuit Against ‘Stem Cell’ Clinics

  1. Let me be clear from the onset, I am not a “biologic denier”. However, in my opinion, biologics are not yet ready for prime time. I truly believe that some day, we will work out the kinks and determine where and when a specific biologic should be used. However, AT THIS TIME, no one has shown me convincing evidence that any biologic is better than our current “non biologic” treatments. The best evidence that I have seen is for PRP in knee arthritis. Even there, the best evidence, and there is significant evidence that argues that biologics do not work, is that PRP is no better than hyaluronic acid although pain relief may last an additional 3 months. in my mind, the stem cell clinics and every other biological treatment should be utilized ONLY as a part of a research protocol. It is interesting that 1 of these defendants is a chiropractor. With all due respect, what can chiropractors do for knee joint arthritis? This is only about money and should be condemned when used in this manner.

    1. There has been FDA approved biologics for decades to treat auto-immune disease, arthritis, and other pathology. This is a FACT. And these are numerous over 350 different biologics from big pharma and other bio-tech companies in the market today. Not to mention live attenuated, dead and mRNA vaccines. These are biologics. (Made from living cells and tissues.) I would not say that the COVID-19 vaccines that are up to 96% effective are not “prime time yet”. PRP has anecdotal evidence for knee OA but probably should not be compared to HA. First PRP is an autologous biological, (made of cells and tissue were the donor and recipient are the same.) and the other HA is an FDA approved medical device. Also know the AAOS does not approve the use of HA for knee OA because of “strong evidence” against its effectiveness. However, if one must compare and that evidence shows that PRP provides longer lasting pain relief for OA, and temporary pain relief is the goal of treatment, well then PRP should be used in lieu of HA. I further think autologous and homologous products should be used prior to other traditional treatments if it is made clear to the patient, they are investigational, and experimental. Some government agencies agree with this opinion as the VA reimburses for PRP and CMS is voting on giving PRP a permeant CPT code at the end of 2021. Finally, chiropractors treat orthopedic conditions without drugs or surgery. Chiropractors can have a positive impact in helping patients with degenerative joint conditions. It’s not a surprise that chiropractors want to help their patients with these live cells and tissue first rather than refer them for drug management or surgery.

      Robert Almeida

  2. I was a client of the Tennessee Center For Regenerative Medicine located in Chattanooga. I attended an evening event where they dangled a cure for my arthritic pain in my face. I could not resist because I was in such great pain and because of their talk I was convinced this was a natural biologic way to solve my arthritic pain. Long story short, I ended up paying for 3 shots one in my right hip (which a year later I had replaced) one in my lower back and one in my right knee. The cost out of my pocket was $12,312. A complete total waste of money. I had to have my right hip replaced because the pain was so intense. I did that after I reached the age for Medicare. Today, my lower back and knee show no signs of pain reduction. I will probably have to have a knee replacement in the future. If there is a lawsuit ever against these people I would like to be included.

  3. I have had prp done in Thailand for $190 6 years ago. Took my blood, spun it in front of me, injected into my Achilles’ tendons and I walked out. It burned a bit for a few days and ached, normal as body is working on healing. Back to sports in a week. The problem is getting the right Dr. who knows what they’re doing. No clinics & no chiropractic in usa! All are bs and even if not hard to know which one to choose. If they are not affiliated or in a top hospital w a real orthopedic doctor injecting it you’re playing Russian Roulette. In usa they don’t make cash unless they’re doing surgery so this can’t ever happen or they would go broke. Just walking into a usa hospital is a car payment. I also did an injection into my hip in the Czech Republic. Again an orthopedic surgeon. No fancy office. Both were against numbing the area as it makes it harder to guide the needle and lessens the healing. Not pleasant but a few minutes of pain I was willing to do. Both worked well. Now back and stuck in usa the costs are $1,580 cash for a simple prp but again worth it if a) orthopedic doctor b)highly accredited w or in a top hospital c) uses a vision assisted probe to guide the needle. The last is needed in usa for your safety as this is not done enough here because the right doctors do not do this regularly (they make cash in surgery)so have less practice. Ask how many they have done (200 and up minimum) and references. Hope this helps.

  4. I too fell victim to the lies and promises of having 98% relief from my chronic pain in my knees. I received an invitation to a dinner presentation from Riverside Biologics Health. The presentation provided such hope for me and I foolishly believed in their “past results”, where they showed new cell generation between joints by injecting Day 1 umbilical cord cells into someone’s knees. I received the shots on October 23, 2020. Had some relief, which I communicated back to them when they would call and check in for the first 3 months. After that, I complained to them that my pain was back 100%. They told me I should try physical therapy. I was out $9000.00. Which I will be paying for a long time still. They make you finance it so they get your money up front and then you have to be responsible to a financial institution (the “Greensky Program”). I wish I would hear that they are getting sued or that there is a class action suit against them that I can join. I get angry every month when I see that $200 payment disappear from my account.

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