The U.S. Food and Drug Administration (FDA) announced its approval of Hope Biosciences Stem Cell Research Foundation’s (HBSCRF) Phase II double blind placebo controlled Parkinson’s clinical trial. The clinical trial will test the efficacy and safety of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells, the first of its kind to administer high doses over several treatments. A randomized portion of the twenty four patients participating in the trial will receive six intravenous infusions, each comprised of 200 million stem cells. HBSCRF Founder, Donna Chang, states, “This is our third FDA-authorized study for Parkinson’s. 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.”
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