SUNRISE, Fla.--(BUSINESS WIRE)--U.S. Stem Cell, Inc. (OTC: USRM), a leader in 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 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.
“This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine,” said FDA Commissioner Scott Gottlieb, MD, in the guidelines.
“With the emerging field of stem cell therapy being dynamic and complex, the FDA is taking great consideration to ensure a comprehensive framework that simultaneously increases access to these innovations and ensures public safety,” added USRM Chief Science Officer Dr. Kristin Comella. “As we expand our business and pioneer this holistic approach, we are confident our position in emerging science will be reflected in the FDA’s regulatory decisions.”
USRM and its clinical affiliates have demonstrated a strong safety profile with in-clinic physician medical procedures, which are aligned with the risk-based approach the FDA intends to enforce. Supporting the belief that patients have a right to utilize their body’s cells to promote natural healing, USRM demonstrates the safety of these therapies in a recent publication within a peer-reviewed journal. The study describes the use of stromal vascular fraction (SVF) in the clinic for degenerative diseases in orthopedics, neurological and systemic conditions in 676 patients.
Additionally, USRM has spent more than $100 million over two decades on preclinical (animal) and clinical (human) trials using its MyoCell™ product; the published trials show culture-expanded autologous stem cells, directly injected into the heart, can provide benefit to congestive heart failure patients. USRM is actively seeking strategic partners to pursue commercialization of MyoCell™ and finalize Regenerative Medicine Advance Therapy (RMAT) designation, based on the draft guidelines published.
About U.S. Stem Cell, Inc.
U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function.
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The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.
