Shares of US Stem Cell Inc (OTCMKTS:USRM) were in steep decline this week after a bombshell was dropped on the company by the FDA and the US Department of Justice. It was just a month ago we were discussing the company’s autologous stem cell procedure here on Street Register, and now it may be in jeopardy.
For the lay-person, autologous stem cell treatment refers to the use of cellular material from the same individual that is receiving the treatment.
US Stem Cell Inc (OTCMKTS:USRM) announced its intention to vigorously defend the lawsuit filed by the U.S. Department of Justice at the request of the U.S. Food and Drug Administration (FDA). The lawsuit seeks to stop US Stem Cell Clinic and related parties from performing a surgical procedure using stem cells from autologous adipose tissue, even when a physician and patient agree that such a procedure is in the best interest of the patient. USRM believes that the patient and physician have the right to decide whether or not to use a patient’s own cells for a therapeutic purpose without federal government interference. (Source: US-StemCell.com)
The government has different ideas altogether, and its allegations alone are enough to stop USRM in its tracks for the time being.
The complaint, filed May 9, 2018 in the Southern District of Florida, is against both US Stem Cell and company officers Kristin Comella and Theodore Gradel. The complaint alleges that USRM manufactures “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the company then markets as stem cell-based treatments.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence. According to the complaint, USRM manufactures its products for these conditions without FDA approval and without proof of safety and efficacy. The Justice Department filed the complaints at the request of the U.S. Food and Drug Administration (FDA).
“Marketing unproven and potentially unsafe treatments puts consumers at risk,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to make sure manufacturers of experimental therapies conduct their research within the safe and legal bounds for drug innovation.”
According to the complaint, USRM has used its products on thousands of patients without first obtaining necessary FDA approvals, and in some cases, adverse events that harmed patients occurred after treatment with the SVF products. In addition, the complaint alleges that the defendant’s misbranded products fail to include adequate directions for use, such as dosages, warnings, and side effects. According to the complaint, recent FDA inspections showed that the USRM’s products are not manufactured, processed, packed, or held in conformance with current good manufacturing practice (CGMP), and they are adulterated as a matter of law.
U.S. Attorney Benjamin G. Greenberg for the Southern District of Florida. “This civil lawsuit reflects the ongoing efforts of the U.S. Attorney’s Offices to safeguard the public from potential harm caused by adulterated and misbranded drugs. Those individuals and corporations that fail to conform with FDA standards are subject to civil enforcement actions.” (Source: justice.gov)
This is very interesting stuff unfolding for a company that purported to be developing highly effective treatments for Psoriasis in particular. If indeed the treatments have been as successful as the company claims, it will be interesting to get more details of the arguments against, being brought by DOJ attorneys.Just stay locked to Street Register for updates, and we’ll deliver important developments on USRM as they unfold. In the meantime, if you’ve yet to sign up for our 100% free newsletter, do so now! Just enter your active email address into the box below and submit!
Disclosure: No one at Street Register has been compensated in any way for the publishing of this article, nor do we hold any position in USRM stock, short or long.