Intermediate Size Expanded Access Protocol Using Autologous HB-adMSCs for the Treatment of Parkinson's Disease
NCT06056427 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-09-29
Summary
This expanded access protocol is part of IND 027396 to evaluate efficacy and safety of multiple intravenous administrations of autologous HB-adMSCs for the treatment of Parkinson's disease for up to 11 patients who passed pre-screening, completed screening, and were not randomized into the treatment group for the HBPD03 clinical study protocol entitled, "A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of autologous HB-adMSCs vs Placebo for the Treatment of Patients with Parkinson's Disease" under IND 027396.
Conditions
- Parkinson Disease
Interventions
- BIOLOGICAL
-
HB- adMSCs (Hope Biosciences adipose derived mesenchymal stem cells)
Participants will receive autologous HB-adMSCs through intravenous infusion only, with a treatment duration of 18 weeks, infusion rate 4-5mL/min and total volume of 250 mL Sodium chloride 0.9%. Each participant will receive a total of 6 doses of HB-adMSCs with a dosing regimen of approximately 2 weeks between infusion 1 and infusion 2, and 4 weeks between the remaining infusions.
Sponsors & Collaborators
-
Hope Biosciences Research Foundation
lead INDUSTRY
Principal Investigators
-
Djamchid Lotfi, MD · Hope Biosciences Research Foundation
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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