Using stem cells from umbilical cords to treat non-arteritic ischemic optic neuropathy
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for the Treatment of Non-arteritic Ischemic Optic Neuropathy
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05147701 · Data updated 2026-11-12
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 |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2022 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05147701 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with non-arteritic ischemic optic neuropathy who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancers, or other serious medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies using stem cells for eye diseases have shown promise, indicating potential for success.
Who can join: the full rules
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 it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Study coordinator: Chadwick Prodromos, MD
- Email: care@thepsci.com
- Phone: 847-699-6810
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.