Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease

Phase 1

Recruiting

• Conditions: Parkinson Disease
• Interventions: Biological: AlloRx; Biological: AlloEx

• Registration Number: NCT05152394
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary

This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease

Detailed Description

This patient funded trial aims to study the safety and efficacy of intranasal installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Parkinson's Disease. Patients will receive a dose of 4 CCs of AlloEx, approximately 800 billion exosomes, between both nasal cavities. A second equivalent dose will be administered on the subsequent day. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-09
• Study Start: 2024-08-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of Parkinson's Disease
• Understanding and willingness to sign a written informed consent document

Exclusion Criteria

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur
• Anticoagulation medicine use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group (AlloRx)	AlloRx	Single intravenous infusion of 100 million cells
Treatment Group (AlloEx)	AlloEx	Intranasal instillations of 4 CCs of AlloEx, approximately 800 billion exosomes. Treatments on back-to-back days, totaling 2 doses.

Primary Outcome Measures

Name	Time	Method
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Trial Locations

Locations (1)

Medical Surgical Associates Center; 🇦🇬 St. John's, Antigua and Barbuda