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COMPLETED
NCT04928287
PHASE2

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

Sponsor: Hope Biosciences Research Foundation

View on ClinicalTrials.gov

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.

Official title: "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"

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2021-06-28

Completion Date

2023-02-06

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, United States