Using stem cells from umbilical cords to treat spinal cord injuries
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05152290 · Data updated 2026-11-12
This study is testing if stem cells from umbilical cords can safely help people with spinal cord injuries recover and improve over time.
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 | July 6, 2022 |
| Main results expected | January 2028 |
| Study ends | January 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05152290 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with spinal cord injuries who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancers, or other significant 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) for treating spinal cord injuries (SCI). Participants will receive either intravenous or intrathecal delivery of 100 million UC-MSCs. The study will evaluate patients' safety and efficacy at multiple time points, including one month before treatment and at 1, 6, 12, 24, 36, and 48 months post-treatment. The aim is to gather data on the potential benefits of this stem cell therapy for SCI patients.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from spinal cord injuries.
How similar studies have gone: Previous studies have indicated that stem cell treatments can be safe and effective for spinal cord injuries, suggesting a promising avenue for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Spinal Cord Injury * 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 * Anticoagulation medicine use
Where it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
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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.