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STEM-PARK: MSCs and Exosomes in Parkinsonism
NCT07471230Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Nov 2028
- Countries
- 1
- Sponsor
- Biocells Medical
- Modality
- Lipid-based Nanoparticles, Stem Cell Therapies
- Conditions
- parkinsonism
01
Overview
Phase 2, randomised, double-blind trial of neuroinduced mesenchymal stem cells and mesenchymal stem cell exosomes in parkinsonism (3 arms), sponsored by Biocells Medical. Primary endpoint: Non-Motor Symptom Scale at 48 weeks. Planned start Nov 2026; status: not yet recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Neuroinduced Mesenchymal Stem Cells
200,000,000 cells via intrathecal injection
Mesenchymal Stem Cell Derived Exosomes
1x10^11 particles via intravenous infusion
Placebo
Saline via intravenous infusion
03
Who it enrols
Patients aged 40-80 with a clinical diagnosis of Parkinsonism (Hoehn and Yahr stage II-III) on stable pharmacological treatment for at least 3 months.
04
Endpoints
Primary
Non-Motor Symptom Scale
Secondary
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
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