Comparing two types of stem cell injections for spinal cord injury treatment
Official title: Safety of Cultured Allogeneic Adult Umbilical-cord or Placental Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05018793 · Data updated 2026-11-12
This study is testing which type of stem cell injection works better for helping people with spinal cord injuries recover.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05018793 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with spinal cord injury 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 intrathecal injections of cultured autologous adult adipose-derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord-derived mesenchymal stem cells for treating spinal cord injuries. Patients diagnosed with spinal cord injury will receive a single injection of either type of stem cell and will be monitored for safety and efficacy over a period of up to 48 months. The study aims to provide insights into the potential benefits of these stem cell treatments for improving patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with spinal cord injuries.
How similar studies have gone: Other studies have shown promise in using stem cell treatments for spinal cord injuries, suggesting potential for success in 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 * Anticoagulation medicine use * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Previous organ transplant * Hypersensitivity to sulfur * Continued drug abuse * Pre-menopausal women not using contraception
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.