Comparing two types of stem cell injections for spinal cord injury treatment
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for the Treatment of Spinal Cord Injury
PHASE1 · The Foundation for Orthopaedics and Regenerative Medicine · NCT05018793
This study is testing which type of stem cell injection works better for helping people with spinal cord injuries recover.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine (other) |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT05018793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with spinal cord injury 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 study could lead to improved treatment options for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using stem cell treatments for spinal cord injuries, suggesting potential for success in 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 * 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 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.
Conditions: Spinal Cord Injuries, spinal cord injury, SCI, stem cell treatment