Infusion of stem cells from umbilical cords for treating inflammatory bowel disease
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Crohn's Disease or Ulcerative Colitis
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05003947 · Data updated 2026-11-12
This study is testing if infusing stem cells from umbilical cords can help people with severe inflammatory bowel disease feel better and improve their treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | June 11, 2022 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05003947 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Crohn's disease or Ulcerative Colitis who are willing to provide informed consent.
✕Probably not a fit
Patients with active infections, cancers, or other significant health issues 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 inflammatory bowel disease (IBD). Participants will receive a single infusion of 100 million stem cells and will be monitored for safety and efficacy at various intervals over a period of up to four years. The study aims to provide insights into the potential benefits of stem cell therapy for IBD, particularly for those with severe disease requiring additional treatments.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from inflammatory bowel diseases.
How similar studies have gone: Previous studies have indicated that stem cell treatments can be safe and effective for inflammatory bowel diseases, suggesting a promising avenue for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Crohn's disease or Ulcerative Colitis * 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.