A few weeks ago, an FDA letter addressed a rogue Arizona stem cell distributor for selling unapproved stem cells; however, that very same firm was listed on NIH database clinicaltrias.gov.
How could a questionable stem cell distributor somehow manage to become listed in the National Institutes of Health database when the FDA had written a letter to R3 Stem Cell, LLC to cease marketing their services? The FDA noted in the letter that based on a review of their website, the FDA declared “it appears that R3 Stem Cell, LLC does not qualify for any exception in 21 CFR 1271.15 and the stem cell therapies offered by R3 Stem Cell, LLC are intended for nonhomologous users and would be regulated as drugs as defined in section 201(g) of the FD&C Act (21 U.S.C. 321(g) and biological products as defined in section 351(i) of the PHS Act (42 U.S.C. 262(i)).”
Hence, a stem cell distributor can only market such products with valid licenses from the FDA. And while in investigational stages, such products may be distributed for clinical use in humans only if the sponsor has secure approval or an investigational new drug application (IND) which R3 Stem Cell did not have reports Eric Boodman of Stat News.
As Stat News reported “Similar scenarios have been popping up like fungi after rain.” Recently a judge ruled the FDA could stop the work of U.S. Stem Cell, the firm’s trial remained on clinicaltrials.gov—stat reports that the postings were no longer actively enlisting patients, but they didn’t mention that the company’s injections had blinded at least four people either reports Mr. Boodman.
Consumers need to be on the lookout for rogue stem cell clinics–and their claims. TrialSite News did a special report on stem cell clinics around the United States that were operating illegally—failing to secure the appropriate regulatory licenses and approvals. In the best cases innocent patients lose their money; in the worst case—their lives.