FDA warns another unapproved cell therapy firm - Bioprocess InsiderBioProcess International

The US FDA has slammed a self-described regenerative cellular therapy manufacturer for selling unapproved umbilical cord blood and umbilical cord products.

California-based Stemell describes itself as an “organization dedicated to leadership, education, service, research and manufacturing of regenerative cellular and cell-free products,” making products StemL UCB-Plus and StemL UCT-Plus, derived from human umbilical cord blood and umbilical cord, for allogeneic use.

However, in the latest example of a crackdown on unapproved stem cell therapies the firm has been at the receiving end of a US Food and Drug Administration (FDA) warning letter.

Image: iStock/Devonyu

“You specifically market your products to “[c]ombat inflammatory conditions such as arthritis” and more generally to “expedit[e] the healing process” and as an alternative to surgery. Stemell also encourages patients to consult with their doctors for more information about “the many additional potential uses” of your products,” the letter states.

Spelling mistakes aside, stem cell-based products with therapeutic intent are defined as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as such the firm is making therapeutic claims about unapproved drugs. To lawfully market these products, an approved biologics license application is needed.

Stemell has a message upon opening its website that states it “does not claim that therapy using StemL products cures or prevents any condition, disease or injury,” and “all statements and opinions provided are for educational and informational purposes only, and we do not diagnose or provide medical or legal advice.”

However, such disclaimers “do not alter the fact that your products are ‘drugs’ and ‘biological products’ within the meaning of the FD&C and PHS Acts, respectively,” the FDA writes.

Additionally, FDA found various deviations cGMP and cGTP during the inspection in March 2019, including failures in establishing and maintaining and documenting cell and tissue donors, failures to establish procedures to prevent microbial contamination, and failures to establish written procedures for production and process control.

FDA clampdown

The warning letter is the latest in the FDA’s push to clampdown on unapproved stem cell therapies and the clinics that make and market them.

Under the previous commissioner Scott Gottlieb, the Agency laid down a regenerative medicine framework aimed at spurring innovation and access to potentially transformative products, which included a push for more actions against rogue actors including warning letters, seizing products and legal action.

Despite initial concern, acting FDA commissioner Ned Sharpless has been no less relenting.

“We know that there are manufacturers and clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The FDA has consistently stated that this is not true,” Sharpless said in a statement relating to the Stemell letter.

“This company failed to take appropriate measures to protect patient safety. The FDA will be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.

“Those who are manufacturing or marketing unapproved, potentially unsafe products must understand that there’s a clear line between appropriate development of these products and those practices that sidestep important statutory and regulatory controls that are in place to protect patients.”