Recently, the U.S. Food and Drug Administration (FDA) cleared the way for a new method of stem cell production at Mayo Clinic in Jacksonville, Florida. It's an automated system that is capable of producing billions of stem cells in a short amount of time.
It took more than four years to develop the process, and this advanced method will increase the production of clinical grade stem cells that will establish the Florida campus among the first automated stem cell manufacturing sites in the U.S.
Guojun Bu, Ph.D., associate director of the Mayo Clinic Center for Regenerative Medicine in Florida, recently explained how this new allowance clears the way for Mayo Clinic to accelerate production of stem cells for clinic trials in an interview on Mayo Clinic Radio.
“With this new technology, we now can develop not just Phase I but also Phase II trials enrolling larger numbers of patients to fully test the efficacy of cell-based therapies,” says Dr. Bu.
Areas that Mayo Clinic researchers will advance the investigation of stem cell therapies include: lung transplant rejection, chronic obstructive pulmonary disease (COPD), inflammatory bowel disease, and graft-versus-host disease, a complication of transplants.
“We know that stem cells can help the body to heal and help to reduce the suffering of many patients, especially complex conditions that we have little current medical treatment,” says Dr. Bu. “With this automated system we can produce billions of cells and not only be able to treat patients but treat multiple patients at the same time.”
Dr. Bu goes on to explain that there are two types of stem cells — stem cells that come from the patient themselves (autologous) and stem cells that are manufactured or developed (allogeneic). Allogeneic stem cells — used in the manufacturing process — come from young, healthy donors, and once they are manufactured using the accelerated production, they can be given it to a different patient.
Learn more about stem cells and the widespread implications of this new manufacturing technology in Dr. Bu’s interview (beginning at the 29.47 mark of the podcast).
This interview originally aired on Mayo Clinic Radio March 17, 2018.