SCIENCE REVOLUTIONIZING REGENERATIVE MEDICINE
With a broad range of scientific disciplines, the main focus of regenerative medicine is understanding the physiology of stem cells, knowing how cells grow and die and what happens in between, learning how differentiation works and understanding the important parts of extracellular matrix (ECM).
The FDA regulates tissue transplant products including stem cells and maintains rigorous industry standards to maximize patient safety. Cellular and tissue products are not classified as drugs by the FDA when they adhere to FDA-defined criteria; rather, they are classified as HCT/P 361 products. Though these products are FDA regulated, they are not FDA approved. Therefore, when seeking cellular and tissue products, it is extremely important to find a company that has a clear and public record of interaction with the FDA.
The FDA has acknowledged that stem cell products have the potential to treat many medical conditions and diseases and have strict regulatory restrictions in place. The FDA routinely reviews manufacturers’ processes and procedures for compliance. As part of the FDA review, investigators must show how each product will be manufactured so the FDA can confirm appropriate steps are being taken to help assure the product’s safety, purity, and efficacy.
While the mechanisms of cellular therapies that have shown great promise in delivering true and permanent healing are not fully known, much anecdotal evidence and many case studies are beginning to guide understanding of this complex but exciting opportunity to enhance lives. Because biologic grafts, cellular therapies, and tissue products are composed of vast numbers of molecules and complex structures, the mechanisms of the effects of properly applied regenerative treatments will take years to unravel.
Always putting safety first, FIOR Bioscience will continue to propel our understanding of mechanism and best practices in regenerative medicine. In the interim, because of our peerless safety record, we are excited to see the continued delivery of this benefit to physicians hoping to do more for their patients. FIOR Bioscience will continue to collect and analyze data as part of the effort to understand and maximize the potential of regenerative medicine.
FIOR Bioscience prepares tissue allografts and cellular products from postnatal birth sources (e.g. umbilical cord, placenta, cord blood). Mesenchymal stem cells (MSCs) are a key component of these tissues and have pluripotent capacity to differentiate into mesodermal and non-mesodermal cell lineages, including – but not limited to – osteocytes, adipocytes, chondrocytes, myocytes, cardiomyocytes, fibroblasts, myofibroblasts, epithelial cells, and neurons.
Stem cells harvested from tissues typically discarded at birth are a rich source of cells that are youthful and have been shown to be more therapeutically active. While once discarded as birth waste, physicians now have the opportunity to change lives in a way that was not possible a decade ago. It is important to clarify that these tissues are only associated with a healthy birth and would have otherwise been discarded. We are grateful to our donors for this incredible gift that has the potential to change so many lives and we wish their children the best in life!
FIOR Bioscience is proud of its 15-year spotless record with the FDA.
Through our meticulous processes developed over decades, we take numerous precautions to ensure that our products are safe, in their purest form and deliver reliable efficacy.