Using stem cells from umbilical cords to treat non-arteritic ischemic optic neuropathy
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Non-arteritic Ischemic Optic Neuropathy
This study is testing if using stem cells from umbilical cords can help people with non-arteritic ischemic optic neuropathy improve their vision and overall eye health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT05147701 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) delivered intravenously and via sub-tenon injection for patients with non-arteritic ischemic optic neuropathy (NAION). Participants will receive a total dose of 100 million cells and will be monitored for safety and efficacy at various intervals over a period of 48 months. For patients with more severe conditions, an additional treatment using their own activated lymphocytes will be provided. The study aims to gather comprehensive data on the potential benefits of stem cell therapy for this eye condition.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with non-arteritic ischemic optic neuropathy who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from non-arteritic ischemic optic neuropathy.
How similar studies have performed: While this approach is innovative, similar studies using stem cells for eye diseases have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Center for Investigation in Tissue Engineering and Cellular Therapy — Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.