NCT04928287

Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)

"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"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hope Biosciences Research Foundation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple HB-adMSCs vs Placebo for the treatment of Parkinson's disease. The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration. This clinical trial will be open to enroll 24 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
BIOLOGICAL	HB-adMSCs	HB-adMSCs will be administered intravenously to study participants who qualify.
OTHER	Placebo	Placebo will be administered intravenously to study participants who qualify.

Timeline

• Start date: 2021-06-28
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2021-06-16
• Last updated: 2026-04-15
• Results posted: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study