Using stem cells from umbilical cords to treat spinal cord injuries
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury
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 |
| 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 | NCT05152290 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) 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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with spinal cord injuries who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other significant medical conditions may not benefit from this study.
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 performed: Previous studies have indicated that stem cell treatments can be safe and effective for spinal cord injuries, suggesting a promising avenue for this approach.
Eligibility criteria
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 this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Athens Beverly Hills Medical Group — Glyfada, Athens, Greece (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.