FDA Flags US Stem Cell for Unapproved Use of Stem Cell Therapies

The US Food and Drug Administration issued a warning letter on Monday (August 28) to US Stem Cell (OTCMKTS:USRM) and Kristen Comella–the company’s chief science officer–for the marketing of and use of their stem cell products without a full review by the agency. 
During a recent inspection, the agency explained that in one of the company’s facilities in Florida, the FDA found evidence of the clinic processing body fat into a stromal vascular fraction. It would then administer this to patient’s spinal cords in order to treat conditions like Parkinson’s disease, amyotrophic lateral sclerosis, or ALS.
“The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use,” the agency stated.

FDA Commissioner Warns US Stem Cell of “exploiting consumers”

On the FDA’s statement, commissioner Scott Gottlieb said the organization is taking new steps to advance novel regulations on cell based medicine to meet the advancements of this regenerative practice.
“Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk,” he said.
Gottlieb continued, stating the agency will take a firm stance against companies that “prey on the medical promise of regenerative cell therapies,” in use with potentially risky treatments.
The FDA also warned US Stem Cell of breaches in the good manufacturing practice (CGMP) and current good tissue practice (CGTP) since December of 2015 and April of this year.
Comella replied to this alert by saying US Stem Cell is not required to follow these practices since it is not a drug manufacturer.
US Stem Cell posted a short video with Comella explaining the company’s response to the FDA’s letter.
In the video, Comella said the company’s priority is the health and safety of their patients and that they have been open with the FDA, claiming they have been letting them openly look at their facilities since 2014.
“It would be a mistake to limit these therapies from patients who desperately need them,” Comella said, adding that the company hasn’t suffered a breach of sterility on their facilities.
The FDA warned the company to correct these issues, otherwise it would face “regulatory action without further notice.” US Stem cell has 15 days to reply in writing to the FDA about any changes, a step Comella said they plan to do.

Investor Takeaway

Since the letter was issued on Monday, the company’s stock price has seen a 34.91 percent decline and to close at $0.02. After continuing its early decrease on its stock on Tuesday, the losses continued as the company dipped 7.41 percent over Tuesday’s trading period.
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Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.