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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• AlloRx — BIOLOGICAL
  cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Study Details

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

Key Dates

First listed

Dec 7, 2021

Start date

Feb 1, 2022

Status verified

Apr 2025

Primary completion

Jan 31, 2026

Completion

Jan 31, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group (AlloRx)
  intravenous and sub-tenon delivery (total dose of 100 million cells)

Primary Outcome Measure

Safety (adverse events) [ Time Frame: Four year follow-up ]

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