Clinical trial Recruiting at 2 sites Phase 1 Interventional

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.

More Rheumatoid Arthritis trials

Quick facts

PhasePhase 1
Study typeInterventional
SexAll
Enrollment20 (estimated)
SponsorThe Foundation for Orthopaedics and Regenerative Medicine
Academic / other
Locations2 sites (Naples, Florida and 1 other locations)
StatusRecruiting
StartedNovember 7, 2021
Main results expectedSeptember 2028
Study endsSeptember 2028
Registry record updatedOctober 20, 2026
Trial IDNCT05003934 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • GenAI-assisted RA bone erosion risk and DMARD choice

    This study tests whether GenAI-based decision support can help doctors assess rheumatoid arthritis bone erosion risk and pick DMARDs for newly diagnosed inpatients.

    Recruiting Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Beijing, Beijing Municipality · NCT07914907

  • Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

    This observational study tests how pain is experienced and measured in people with rheumatic diseases compared with healthy volunteers.

    Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07829497

  • Telitacicept for difficult-to-treat rheumatoid arthritis

    This study tests whether adding telitacicept to standard therapy helps adults with hard-to-treat rheumatoid arthritis see better control of their symptoms.

    Recruiting Phase 2 Peking University People's Hospital · Hefei, Anhui and 46 other locations · NCT07796516

  • PTC844 in people with active rheumatoid arthritis

    This study tests whether PTC844 is safe and how it behaves in the body compared with placebo for people with active rheumatoid arthritis.

    Recruiting at 6 sites Phase 2 PTC Therapeutics · Chandler, Arizona and 25 other locations · NCT07779616

  • First-in-human test of CND319 in healthy people and people with rheumatic diseases

    This early study tests whether CND319 is safe and tolerable and whether it shows any signs of activity in healthy adults and in people with rheumatoid arthritis or Sjogren's syndrome.

    Recruiting Phase 1 Candid Therapeutics · Melbourne, Victoria · NCT07712939

  • IV sarilumab for adults with rheumatoid arthritis

    This study tests IV sarilumab to see how it works and how safe it is for adults with moderately to severely active rheumatoid arthritis, with or without certain standard arthritis medicines.

    Recruiting at 12 sites Phase 1/2 Sanofi · Centennial, Colorado and 11 other locations · NCT07704580

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.