Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillations for Stroke

Phase 1

Recruiting

• Conditions: Stroke
• Interventions: Biological: AlloRx; Biological: AlloEx

• Registration Number: NCT05158101
• 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 Stroke

Detailed Description

This patient funded trial aims to study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Stroke. Patients will receive intranasal instillations between both nasal cavities of UC-MSC exosomes. The total dose will be 4 CC of AlloEx, approximately 800 billion exosomes, for each day. Patients will receive instillations on back-to-back days totaling 2 doses. 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.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-15
• Study Start: 2022-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Diagnosis of Stroke
• 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

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 between both nasal cavaties, which is approximately 800 billion exosomes in total. Second dose of 4 CCs to be receive the following day.

Primary Outcome Measures

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

Trial Locations

Locations (2)

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

Center for Investigation in Tissue Engineering and Cellular Therapy; 🇦🇷 Buenos Aires, Argentina