Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for NAION

Phase 1

Recruiting

• Conditions: Eye Diseases; Retinitis Pigmentosa; Diabetic Retinopathy; Macular Degeneration; Traumatic Optic Neuropathy; Optic Atrophy
• Interventions: Biological: AlloRx

• Registration Number: NCT05147701
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of non-arteritic ischemic optic neuropathy

Detailed Description

This patient funded trial aims to study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of non-arteritic ischemic optic neuropathy. The total dose will be 100 million cells. 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: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-07
• Study Start: 2022-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

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

Inclusion Criteria

• Diagnosis of NAION (non-arteritic ischemic optic neuropathy)
• 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	intravenous and sub-tenon delivery (total dose of 100 million cells)

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)

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

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