Actively Recruiting
Phase 1 Study of Intranasal Allogeneic Umbilical Cord Mesenchymal Stem Cell Exosomes to Treat Parkinsons Disease
Led by The Foundation for Orthopaedics and Regenerative Medicine · Updated on 2025-04-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of using cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes delivered through the nose to treat Parkinsons Disease. This patient-funded Phase 1 trial focuses on understanding how these biological exosomes may impact patients with this condition over a four-year period. Participants will receive two doses of the investigational treatment called AlloEx, each consisting of 4 CCs containing approximately 800 billion exosomes, administered intranasally on consecutive days. This treatment group represents the experimental intervention being studied. Participants will be assessed before treatment and then followed up at 1, 6, 12, 24, 36, and 48 months after treatment. Safety will be monitored through adverse event tracking, and efficacy evaluations will also be conducted throughout the study. This long-term follow-up aims to provide comprehensive information about the treatments impact over four years.
CONDITIONS
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease
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