NCT05147701

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

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Non-arteritic Ischemic Optic Neuropathy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Foundation for Orthopaedics and Regenerative Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Eye Diseases
• Retinitis Pigmentosa
• Diabetic Retinopathy
• Macular Degeneration
• Traumatic Optic Neuropathy
• Optic Atrophy

Interventions

Type	Name	Description
BIOLOGICAL	AlloRx	cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2021-12-07
• Last updated: 2025-04-17

Locations

2 sites across 2 countries: Antigua and Barbuda, Argentina

Regulatory

• FDA-regulated drug study