NCT05003934 Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA
| NCT ID | NCT05003934 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-11-07 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2021-11-07 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis
Eligibility 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
Contact & Investigator
Chadwick Prodromos, MD
PRINCIPAL INVESTIGATOR
The Foundation for Orthopaedics and Regenerative Medicine
Frequently Asked Questions
Who can join the NCT05003934 clinical trial?
This trial is open to participants of all sexes, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05003934 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05003934 currently recruiting?
Yes, NCT05003934 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Foundation for Orthopaedics and Regenerative Medicine to inquire about joining.
Where is the NCT05003934 trial being conducted?
This trial is being conducted at St John's, Antigua and Barbuda, Buenos Aires, Argentina.
Who is sponsoring the NCT05003934 clinical trial?
NCT05003934 is sponsored by The Foundation for Orthopaedics and Regenerative Medicine. The principal investigator is Chadwick Prodromos, MD at The Foundation for Orthopaedics and Regenerative Medicine. The trial plans to enroll 20 participants.
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