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