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

NCT04928287 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-15

Study results available
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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

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.

Sponsors & Collaborators

  • Hope Biosciences Research Foundation

    lead INDUSTRY

Principal Investigators

  • Djamchid Lotfi, MD · Hope Biosciences Stem Cell Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-28
Primary Completion
2023-02-06
Completion
2023-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928287 on ClinicalTrials.gov