Research & Development
Hope Biosciences Stem Cell Research Foundation wins FDA's approval for simultaneous stem cell trials for Parkinson's Disease
22 June 2021 -

Non-profit research company Hope Biosciences Stem Cell Research Foundation (HBSCRF) reported on Monday the receipt of Food and Drug Administration (FDA) authorisation for a free Phase II clinical trial of stem cells in subjects with Parkinson's Disease.

The US FDA has approved the company's Phase II free clinical trial to assess the efficacy and safety of multiple intravenous infusions of allogeneic adipose-derived mesenchymal stem cells in improving daily living and quality of life in patients with Parkinson's Disease.

This 60-patient trial is the second FDA clinical trial authorisation in Parkinson's for the company, which already has a 24-patient double-blind placebo trial underway utilizing autologous adipose-derived mesenchymal stem cells. Participants can be male or female, between 45-80 years of age and must have been diagnosed with mild-to-moderate Parkinson's at least two years prior to commencement.

In conjunction with the approval, the company said it will become the first research organization in the US to conduct simultaneous trials examining effects of administering the patient's own cells (autologous) and donor cells (allogeneic) for Parkinson's Disease.

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