NCT06858254

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Apeiron Research Center · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Parkinson Disease (PD) and Parkinson-Plus Syndrome (PPS) are complex neurodegenerative diseases (NDDs) affecting more than 10 million people worldwide. The clinical application of stem cell therapy holds great promise in the treatment of NDDs by promoting regeneration and modulating immune responses with bone marrow aspirate, in particular, holding considerable potential in neural repair and recovery. However, current approaches often rely on university-based laboratories and invasive delivery approaches, raising patient safety, accessibility, and cost concerns. Additionally, NDDs present with distributive and heterogenous pathology, complicating treatment strategies. As pharmaceutical and biotech companies develop targeted stem cell therapies, most focus on localized brain structures rather than targeting PD/PPS systemically. Advancing consensus between scientific research and clinical application is critical for earlier detection in the prodromal phase, identifying epigenetic risk factors, and developing therapeutics that provide a broader, more effective treatment. The primary objective of this study is to measure outcomes using autologus bone marrow mesenchymal stem cells (BM-MSCs) on motor and non-motor function in persons with PD/PPS. The trial will include 60 participants (40 with PD, 20 with PPS) who will complete 7 scheduled encounters (4 in-person visits, 3 remote visits) that occur every 3 months in an alternating manner. There will be 4 treatment groups (2 PD, 2 PPS) who will be administered intranasal bone marrow aspirate and intravenous bone marrow aspirate in a crossover pattern at three of the four in-person visits (Day 0, 6 months and 12 months).

Conditions

• Atypical Parkinsonism
• Parkinson Disease (PD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2025-03-05
• Last updated: 2025-03-05

Regulatory

• FDA-regulated drug study