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

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

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Key information

Conditions

Eye Diseases Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Macular Degeneration Nervous System Diseases Optic Atrophy Optic Nerve Diseases Optic Nerve Injuries Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Trauma, Nervous System Traumatic Optic Neuropathy Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Surgical Associates Center, St John's, Antigua and Barbuda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AlloRx

Biological

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Primary outcomes

Safety (adverse events)

Time frame: Four year follow-up

Clinical monitoring of possible adverse events or complications

Sponsors and collaborators

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Dec 7, 2021
Registry last updated: Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed