![]() For example, amniotic fluids contain collagen, extracellular matrix proteins, and growth factors which may promote the regenerative healing of tissue. To be clear, even in the absence of living stem cells, amniotic fluid and membrane products may still be helpful in the cell regenerative process. Therefore, any medical companies (or their marketing representatives) representing that their amniotic products contain living stem cells would be subject to FDA enforcement. If any living stem cells remain, the amniotic product would be classified as a drug and would not be marketable until clinical trials are conducted. The problem is that although stem cells have been found in fresh amniotic fluids and membranes, the processing of these products effectively sterilizes the stem cells that may have been present. This is especially troubling in the case of amniotic fluid and membrane products. In fact, since December 2019, the agency has issued more that 350 letters to manufacturers, clinics and health care providers cautioning them about offering unapproved regenerative medicine products. ![]() The FDA has expressly noted that some regenerative stem cell products have been illegally marketed, are not effective, and in cases may pose significant patient safety issues. In the absence of such a license, the selling and marketing of amniotic fluid products may be problematic. As such, they would require an approved Biologics License Application prior to marketing. Based on the November 2017 guidance, the FDA determined that amniotic fluid falls under Section 351 of the Public Health Service (PHS) Act. In November 2017, the FDA first issued guidance covering the development and oversight of regenerative medicine products. Food and Drug Administration (FDA) is responsible for regulating regenerative medicine products (such as stem cell products). ![]() Today, the number of companies researching, and marketing stem cell treatment applications is ever-expanding. While stem cell therapies are currently all the rage, it is worth noting that they were first used in 1958 by George Mathe, a French Oncologist, who performed stem cell transplants of bone marrow grafts to treat six nuclear scientists who had been accidentally exposed to radiation. Stem cells are highly specialized human cells that have the potential to develop into many different cell types, ranging from muscle cells to brain cells. Stem Cell Therapies Using Amniotic Fluid / Amniotic Membrane Tissue Products:ĭespite all the hype surrounding their potential clinical applications, stem cells truly are amazing. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |