The US Food and Drug Administration (FDA) planned to speed up the process to regulate Stem Cell Therapy so that it would be both safe and effective for patients. Months ago, the FDA led a crack down on stem cell clinics, however it announced later on that it will support innovation in Stem Cell treatment, according to CNN.
FDA announced that there needs to be a balance between safety and innovation when it comes to the possibilities of using stem cells in medicine. This evaluation was based on a paper written by Dr. Scott Gottlieb, the FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
FDA’s aim is to adjust its traditional tools used for regulation of Stem Cell Therapy so that it could meet modern challenges and opportunities created by innovative products used as stem cell Regenerative Medicine Treatment. Gottlieb and Marks also remarked that despite the widespread application of stem cells as Regenerative Medicine, the clinical benefits still have not yet been clearly proven.
Paul Knoepfler, professor of cell biology and human anatomy at the University of California, Davis School of Medicine, who wrote a blog post about the paper said to CNN, “The FDA seems to be saying they want to find a sweet spot of stem cell oversight where they encourage innovation by good citizens and yet also carefully regulate this sphere as well as encouraging those interested in transplanting stem cells into patients to work with the FDA.”
Proving Effectiveness of Stem Cell Treatment Through Multipotent Stromal Cells
FDA have acknowledged the many benefits of Stem Cell Therapy. Currently, Stem Cell technology has the ability to regenerate all types of complex tissue which gives the potential for stem cells the ability to treat diseases. Stem cell therapies can treat illnesses infecting the blood, including acute myeloid leukemia and HIV infections. One of the ways Stem Cell Treatment is used is through Regenerative Treatment which involves the process of destroying the diseased immune system and transplanting healthy hematopoietic stem cells, instead. Hematopoietic cells play a role in replenishing the lost immune cells without restoring the disease. Besides treating illnesses, stem cells also has the ability to repair visual impairment or slow down the aging process.
Despite research that Stem Cell Therapy could help treat diseases, there are limited ways to prove its effectiveness. Currently, stem cell- based products are tested by the FDA using a small number of cell surface markers and by measuring cell product activity.
One of the ways FDA is trying to create a high standard in Stem Cell therapy is through studying multipotent stromal cells. FDA’s Multipotent Stromal Cell Consortium, a team of scientists studying these cells are hoping that it could help in standardizing and developing stem cell therapy practices. Multipotent stromal cells differentiate into a variety of cell types and could contribute to tissue repair or help replace, restore or regenerate other parts of the body.
Steven Bauer, chief of the cellular and tissues therapy branch in the Center for Biologics Evaluation and Research, gave a presentation that focused on how multipotent stromal cells can ensure predictability in its result in therapies. He concluded that using the information from the studies of the cells could help generate standards of Stem Cell Therapy that could help further develop regenerative medicine and products.