Regenerative Medicine witnessed a giant leap towards the future when the U.S. Food and Drug Administration (FDA) has finally granted Mayo Clinic the permission to use its platform for the production of automated stem cells in large quantities, after more than four years of evaluation. The manufacturing site, which is located in Jacksonville, Florida, can produce as much as billions of stem cells in a short period of time. These stem cells will be obtained from a healthy donor, as well as manufactured according to the clinical standard.
Stem Cells, which are the basic building blocks of the human body, have the ability to regenerate and replicate to become any specialised type of cells. They are known to have the potential to promote tissue repair and healing of several tissues, including bone, heart, and brain.
With the exponential increase of the quantities of stem cells, this initiative by FDA will pave ways for significant medical advancement. First, it could rise as the solution for cells insufficiency. The current Stem Cell production has long been a time-consuming and a labor-intensive process, in which researchers must carefully cultivate hundreds of flasks only to produce enough stem cells for a few patients. The surplus of the supplies now means Stem Cell treatment for a wide-range of conditions is made available for patients even on a short notice.
Moreover, the large quantities of stem cells can also facilitate further clinical studies. “Although Mayo Clinic has been poised to scale up regenerative clinical trials, to date we did not have the capacity to support them. With this new technology, we can now develop phase II trials enrolling larger numbers of patients to fully test the efficacy of cell-based therapies,” said Dr. Abba Zubair, M.D., Ph.D., a medical director of Transfusion Medicine and the Human Cell Therapy Laboratory on the Florida campus.
Mayo Clinic will proceed with Stem Cell trials on various complicated medical conditions, adding valuable knowledge to the field. As resources grow with further research and clinical trials underway, Regenerative Medicine’s potential to treat several currently untreatable diseases is no longer in the distant future.
H/T: Mayo Clinic News Network