Infusion of stem cells from umbilical cords for treating rheumatoid arthritis
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion and Intra-Articular Injection for the Treatment of Rheumatoid Arthritis
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05003934 · Data updated 2026-11-12
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 |
| 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 | November 7, 2021 |
| Main results expected | September 2028 |
| Study ends | September 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05003934 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with rheumatoid arthritis who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancers, or other serious health 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 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.
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 gone: Previous studies have indicated that stem cell treatments can be safe and effective for rheumatoid arthritis, suggesting a promising avenue for this approach.
Who can join: the full rules
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 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.