FDA OKs Second Trial to Test Effects of Stem-cell Infusions
The U.S. Food and Drug Administration (FDA) has approved a Phase 3 trial to test multiple infusions of fat-derived mesenchymal stem cells — ones obtained from healthy donors — in people with Parkinson’s disease.
The Hope Biosciences Stem Cell Research Foundation (HBSCRF), which received the authorization, already has a similar study underway that is examining the efficacy of such infusions using patients’ own fat-derived mesenchymal stem cells.
That Phase 2 study (NCT04928287) — which is ongoing at HBSCRF, in Sugar Land, Texas, and is currently enrolling participants — is testing in parallel a patient’s own (autologous) fat-derived mesenchymal stem cells compared with a placebo. Up to 24 patients will be able to enroll in this study; more information is available here.
In the new Phase 3 trial, up to 60 men and women, ages 45-80, will be recruited. Eligible participants will have been diagnosed in the previous two years with mild to moderate Parkinson’s disease. Those interested in learning more information about this trial can call 346-900-0340.
The new trial will test the safety and effectiveness of donor fat-derived mesenchymal stem cells, delivered as an intravenous (into-the-vein) infusion, in improving a patient’s ability to conduct daily activities and on quality of life.
Adipose-derived, meaning fat-derived, stem cells are advantageous for use because they can be acquired through a minimally invasive procedure called a lipectomy — a surgical procedure to remove body fat.
“We have to explore every facet of how adipose-derived mesenchymal stem cells act in this disease condition,” Donna Chang, HBSCRF’s founder, said in a press release.
The cells can be acquired from the patient — autologous — or from a donor, in which case it’s called allogeneic. While a patient’s own stem cells have clear advantages, such as a lower risk for rejection of the transplant, acquiring the necessary numbers for infusion is often a major limitation. Moreover, the cells need to be isolated , expanded in the lab, and frozen for future use, which can be a timely process.
“Our primary research focus has always been on autologous stem cells, but in COVID, for example, when we ran three simultaneous studies in prevention and treatment, we encountered a situation where people needed cells but did not have their stem cells banked,” Chang said.
Using donor-derived cells helps bypass some of these limitations as they’re more readily available.
“To serve those patients, we stepped into the world of allogeneic studies and discovered safety intact,” Chang said.
“We recognize that there is a population of patients who need help immediately and could benefit from the use of allogeneic cells,” she said. “We see it as our responsibility to explore the possibilities, and we are hopeful that these trials will yield valuable information individually and as a research set.”