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NOT YET RECRUITING
NCT06858254
PHASE1/PHASE2

Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism

Sponsor: Apeiron Research Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.

Official title: Standard Optimization of Autologous Stem Cells by Intranasal and Intravenous Administration to Treat Parkinson's Disease and Atypical Parkinsonism

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-04-01

Completion Date

2028-04

Last Updated

2025-03-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous mesenchymal stem cells

1. Participant's blood is drawn at the start of each visit. 2. Bone marrow aspirate is drawn from the posterior aspect of the pelvis and is subsequently harvested and processed. 3. The following procedures are administered in a crossover design (Day 0 and 6 months): * Intranasal bone marrow aspirate administration (INA BMAC) OR Sham INA * Intravenous bone marrow aspirate administration (IV BMA) OR Sham IVA 4. At 12 months, all participants receive IV BMA + INA BMAC