FDA approves Second Trial for Parkinson’s
The FDA approved a Phase 3 clinical trial for Hope Biosciences Stem Cell Research Foundation (HBSCRF) to test multiple infusions of fat-derived mesenchymal stem cells in patients with Parkinson’s. They are running a similar trial at the moment testing the efficacy of patients’ own fat-derived mesenchymal stem cells. It is identified as NCT04928287.
The study will recruit as many 60 men and women, ages 45-80, who have been diagnosed with mild to moderate Parkinson’s disease. Potential volunteers that want to participate in the study can call 346-900-0340.
Researchers will examine the the safety and effectiveness of donor fat-derived mesenchymal stem cells. Lipectomy is the minimally invasive procedure where body fat is removed to acquire stem cells.
“We have to explore every facet of how adipose-derived mesenchymal stem cells act in this disease condition,” Donna Chang, HBSCRF’s founder, said.
Clinicians can obtain the cells from the patient, autologous, or from a donor, allogeneic. Although there are advantages to using a patient’s stem cells. It is necessary to isolate, and prepare their cells in the lab prior to clinical use. It means more time is taken from clinicians and patients.
Physicians can see advantages in using regenerative medicine from donor’s cells, including safety, consistency, comfort for patients, and other considerations.
“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.
“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.”
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