Randomized Clinical Trial in Parkinson's Disease Patients Using Pluripotent Adipose Stem Cells (PASCs)
NCT06141317 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-12-01
Summary
The purpose of this study is to assess the safety and efficacy of allogenic pluripotent stem cells isolated from adipose tissue (PASCs) in patients with Parkinson's Disease.
Conditions
- Parkinson Disease
Interventions
- BIOLOGICAL
-
PASC transplantation (25 million PASCs/patient)
3 doses of 25 million PASCs implantation via peripheral vein (Day 0, 3 months, 6 months)
- BIOLOGICAL
-
Control
0.9% saline solution via peripheral vein (Day 0, 3 months, 6 months)
Sponsors & Collaborators
-
Universidad de Costa Rica
collaborator OTHER -
University of California, Los Angeles
collaborator OTHER -
ClusterXStem-Costa Rica
lead OTHER
Principal Investigators
-
Freddy Henriquez, M.D. · Hospital Clínica Católica
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-23
- Primary Completion
- 2024-09-01
- Completion
- 2024-11-01
Countries
- Costa Rica
Study Locations
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