NCT06056427

Intermediate Size Expanded Access Protocol Using Autologous HB-adMSCs for the Treatment of Parkinson's Disease

An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Autologous HB-adMSCs for the Treatment of Patients With Parkinson's Disease

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Hope Biosciences Research Foundation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• First posted: 2023-09-28
• Last updated: 2025-09-29