FDA Authorizes Novel Stem Cell Trial for Parkinson’s
SUGAR LAND, Texas--(BUSINESS WIRE)-- Houston-area non-profit Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a Phase II double-blind placebo controlled clinical trial to assess the efficacy and safety of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells to improve activities of daily living and quality of life in subjects with Parkinson’s Disease.
The trial is the first globally to administer pure adipose-derived mesenchymal stem cells to Parkinson’s patients in such high quantities over repeat treatments. Twenty-four patients will be randomized to receive six intravenous infusions of 200 million stem cells each.
“This is our third FDA-authorized study for Parkinson’s,” elaborates HBSCRF Founder Donna Chang. “The first two were FDA-authorized expanded access, single-patient studies. From those, we gained an idea of what doses and periodicity of stem cell yielded dramatic results, and so were able to design this larger clinical trial very deliberately. This is exactly how clinical research works at its best – every patient provides greater understanding. We are hopeful this larger trial will confirm what we see in the expanded access studies and help get treatment to more people and families.”
HBSCRF’s first Parkinson’s patient has received more than 20 infusions to date, experiencing what the study’s primary investigating physician notes as “remarkable improvement” in activities of daily living. The patient no longer requires a 24-hour caretaker, and the neurologist overseeing their treatment states the patient “has no sign of disease.” HBSCRF’s second Parkinson’s patient receives their third dose of stem cells this week.
“Stem cells are the hope for degenerative conditions, but success is only possible with continued administration of healthy, fresh, viable cells,” continues Chang. “We have finally overcome the major hurdles of cell therapy. Now we must figure out how many doses it takes to deliver consistent results. We are just scratching the surface of potential for these cells.”
Participants can be male or female, between 18-75 years of age, and must have been diagnosed with mild-to-moderate Parkinson’s at least six months prior to commencement. There is no cost, but because this is an autologous study, patients must have their cells banked prior to entering the trial to be eligible.
To date, HBSCRF has obtained FDA authorization for 17 clinical studies in 10 disease areas, administering nearly 100 billion cells at zero charge to patients over the last year.
For more trial information, please call (346) 900-0340.
Source: Hope Biosciences Stem Cell Research Foundation