San Juan Capistrano, California - The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., 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.”

As highlighted in 2017 with the release of the FDA’s comprehensive regenerative medicine policy framework, including the FDA’s final guidance (Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use), the FDA intends to apply a risk-based approach to compliance and enforcement of cell-based regenerative medicine products, taking into account how products are being administered as well as the diseases and conditions for which they are intended to be used. The agency noted that it intends to exercise enforcement discretion for certain products until November 2020 with respect to FDA’s investigational new drug application and premarket approval requirements when the use of the product does not raise reported safety concerns or potential significant safety concerns. However, the FDA does not intend to exercise such enforcement discretion for those products that pose a potential significant safety concern to patients. As reflected by this warning letter, the other letters issued today, and other correspondence issued recently, the FDA will take appropriate steps to protect the public health.

The FDA offers opportunities for engagement between potential manufacturers and the agency, such as through the INTERACT program, to facilitate product development. It also encourages the use of its expedited programs whenever applicable, in addition to the collaborative development of products as the former FDA Commissioner and Center for Biologics Evaluation and Research director discussed in a New England Journal of MedicineExternal Link Disclaimer perspective. In addition, the FDA recently announced a temporary program called the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), which is intended to assist manufacturers of human cells, tissues, and cellular and tissue-based products (including stem cells) to obtain a rapid, preliminary, informal, non-binding assessment from the agency regarding how their specific products are regulated.

The FDA requested a response from Stemell, within 15 working days of the letter’s issuance, that details how the deviations noted in the warning letter will be corrected. Deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.

Health care professionals and consumers should report any adverse events related to treatments with the Stemell products or other stem cell treatments to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178. The FDA monitors these reports and takes appropriate action necessary to ensure the safety of medical products in the marketplace.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.