NCT04506073

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease

A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 50 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to select the safest and most effective number of repeat doses of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the progression of Parkinson's disease (PD).

Detailed description

Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as disease modifying therapy for PD. The design includes three treatment arms with 45 patients.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Mesenchymal Stem Cells	1 dose is 10 X 10\^6 MSC/kg
DRUG	Placebo	Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).

Timeline

• Start date: 2020-11-09
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2020-08-10
• Last updated: 2024-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study