Infusion of stem cells from umbilical cords for treating rheumatoid arthritis
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Rheumatoid Arthritis
This study is testing whether infusing stem cells from umbilical cords can help people with rheumatoid arthritis feel better and improve their symptoms.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT05003934 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of intravenous infusions of cultured allogeneic adult umbilical cord-derived mesenchymal stem cells in patients with rheumatoid arthritis (RA). Participants will receive a single infusion of 100 million stem cells and will be monitored for safety and effectiveness at various intervals over a period of up to four years. The study aims to assess the potential of this innovative treatment approach in improving outcomes for RA patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with rheumatoid arthritis who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for managing rheumatoid arthritis symptoms and improving patient quality of life.
How similar studies have performed: Previous studies have indicated that stem cell treatments can be safe and effective for rheumatoid arthritis, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis * 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 this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Center for Investigation in Tissue Engineering and Cellular Therapy — Buenos Aires, Argentina (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.