Mayo’s Regenerative Medicine Plans Get Boost with Transport Safety Finding
Following the landmark announcement last month that federal regulators have approved Mayo Clinic’s bid to automate the production of stem cells in Jacksonville, Florida, a new study has shown they can be safely transported across long distances without losing their effectiveness.
That finding means many of the billions of stem cells to be produced in Florida could be safely frozen and shipped to Mayo’s Rochester clinic to carry out large-scale clinical studies there as researchers seek to boost the applications of regenerative medicine into their next level.
The Mayo Clinic Center for Regenerative Medicine made international news in January when it announced the U.S. Food and Drug Administration had approved its bid to launch a revolutionary, bioreactor-based automation platform capable of producing several billion bone marrow-derived mesenchymal (adult) stem cells in a matter of days.
In particular, the Jacksonville-based platform will enhance the production of stem cells obtained from a healthy donor, as opposed to stem cells taken from, and returned to, the same patient.
Stem cell production has long been a labor-intensive process in which researchers cultivate hundreds of tissue-culture flasks over the course of months to produce enough cells for a few patients. The problem is the cells are needed on a much larger scale to support Phase II clinical studies testing the effectiveness of stem cell therapies in against a wide range of diseases and conditions.
One of those first applications will likely be to battle a condition that strikes the recipients of lung transplants: bronchiolitis obliterans syndrome, or BOS, in which inflammation and scarring occurs in the smallest airways of the transplanted organ. This causes significant discomfort and shortness of breath and can ultimately lead to the need for a re-transplant, or even be fatal.
Researchers have found that an infusion of stem cells can be used to mobilize the immune system and reduce inflammation. In fact, the results of a Mayo-backed Phase I study published earlier this month showed it is safe to use bone marrow-derived adult stem cells – in this case, all coming from a single, healthy donor – against BOS.
The results pave the way for a larger-scale Phase II study, which would seek to enroll many more patients. But along with safety finding, the study led by Mayo pulmonologist Dr. Cesar Keller also determined that shipping the Wisconsin-manufactured stem cells to Jacksonville for use in the study did not compromise their sterility or viability.
“Our results showed that indeed the logistics of preparing, transporting, and infusing cells was feasible and safe,” Keller said in a blog entry posted by the Center for Regenerative Medicine.
This finding, in effect, opens the door for the large-scale transportation of stem cells produced using the new automation platform in Florida to Mayo’s other facilities in Rochester and Scottsdale, Arizona, thus establishing them as major hubs for what is likely to be many large-scale regenerate medicine clinical studies to come in the future.