The FDA have issued a warning to a US based company for improper use of umbilical tissue in unapproved stem cell therapy.
The U.S. Food and Drug Administration (FDA) have issued a warning to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices and environmental monitoring, creating potential significant safety concerns that put patients at risk. Stemell’s unapproved products derived from umbilical cord blood and umbilical cord are StemL UCB-Plus and StemL UCT-Plus.
“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,” said Acting FDA Commissioner Ned Sharpless, M.D. “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.”
The FDA’s recent inspection of the Stemell facility in March revealed that the company was manufacturing products derived from human umbilical cord blood and umbilical cord for use in recipients unrelated to the donors of the products. Because these Stemell products are not intended for homologous use only (i.e., to perform the same basic function or functions in the recipient as in the donor) and fail to meet other criteria set forth in applicable FDA regulations, they are regulated as both drugs and biological products. To lawfully market these products, an approved biologics license application is needed. While in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. However, no such licenses or INDs exist for these Stemell products.
During the inspection, the FDA documented evidence of significant deviations from CGTP and CGMP requirements in the manufacture of Stemell’s products, including deficient donor eligibility practices, unvalidated manufacturing processes, deficient environmental monitoring and inadequate aseptic processes. These deviations pose a risk that the products may be contaminated with viruses or microorganisms or have other serious product quality defects.
“The FDA remains highly committed to facilitating the development and availability of safe and effective cellular therapy products. However, we will not hesitate to take appropriate action to protect people from being harmed by products with potential significant safety concerns,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to the warning letter issued today, we sent another 20 letters to manufacturers and health care providers across the country who may be offering unapproved stem cell products, reiterating the FDA’s compliance and enforcement policy. We remain very concerned that countless clinics across the country continue to market violative stem cell products to patients that have not been appropriately evaluated for safety or efficacy.”