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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":"SUNRISE, FL / ACCESSWIRE / November 21, 2017 / U.S. Stem Cell, Inc. (OTCQB: USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, today responded to the recently announced Food and Drug Administration's comprehensive policy framework for the development and oversight of regenerative medicine products, including stem cell treatments.The framework is described in a suite of four guidance documents that build upon the FDA's existing, risk-based regulatory approach, in order to more clearly describe what products are regulated as drugs, devices, and/or biological products. Two of the documents were issued as drafts, and the other two were issued as final.This new framework also includes more regulatory guidance for off-the-shelf products that, due to their construct, require more complex, lengthy and expensive entries to market. This is partially because they can involve using third-party stem cells that have been modified, including genetically, which can require more intense scrutiny by the FDA. USRM believes that it's in-clinic stem cell procedures should not be subject to the same regulatory process as off-the-shelf drug products.Likewise, due to the high ramp-up costs with an off-the-shelf gene or cell therapy product, patients can be up against prices of $475,000 per treatment. USRMs proprietary in-clinic protocols using the patients own tissues/cells are not off-the-shelf gene or cell therapies and can be safely performed in-clinic instead of a hospital, by physicians that are USRM-trained and certified in autologous stem cell therapy practices - procedures that have been and continue to be well documented in the scientific literature with very few complications reported. The costs to patients typically range from $5,000-$12,000.\"As U.S. Stem Cell continues to offer products, education and in-clinic therapeutic services, we are continuing our ongoing communication with the FDA in order to determine more specifically how we best fit into the regulatory model for stem cell therapies,\" said Mike Tomas, President & CEO of U.S. Stem Cell, Inc. \"Our goal is to provide patients in need with regenerative medicine using the cells inside their own body, and we are hopeful that the FDA is willing to continue to work with us to help define fair regulation ...