U.S. Stem Cell responded to the recently-announced Food and Drug Administration’s (FDA) comprehensive policy framework for the development and oversight of regenerative medicine products, including stem cell treatments.
The framework is described among four FDA guidance documents that build upon its existing, risk-based regulatory approach that further describes regulation of drugs, devices, and/or biological products. It also includes regulatory guidance for off-the-shelf products that, due to their construct, require complex, lengthy and expensive entries to market, since they can involve using modified, third-party stem cells, which can require intense FDA scrutiny. According to USRM, its in-clinic stem cell procedures should not be subject to the same regulatory process as off-the-shelf drug products.
Due to high ramp-up costs with off-the-shelf gene or cell therapy products, patients can face prices of $475,000 per treatment. USRM’s proprietary, in-clinic protocols, using the patient’s own tissues/cells, are not off-the-shelf gene or cell therapies. Treatments are safely performed in-clinic, instead of a hospital, by physicians who are USRM-trained and certified in autologous stem cell therapy practices — procedures that are well documented in scientific literature, with few reported complications, and costs $5,000-$12,000.
“As U.S. Stem Cell continues to offer products, education and in-clinic therapeutic services, we remain in communication with the FDA to determine how we best fit into the stem cell therapies regulatory model,” said U.S. Stem Cell, Inc. President & CEO Mike Tomas. “We are hopeful the FDA will work with us to define fair regulation for the public.”
According to the FDA, these guidelines are intended to balance the agency’s commitment to safety, with mechanisms to drive advances in regenerative medicine, for innovators to bring patients new, effective therapies, quickly and safely.