Infusion of stem cells from umbilical cords for treating inflammatory bowel disease
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease
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 |
| Enrollment | 15 (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 | NCT05003947 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 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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Crohn's disease or Ulcerative Colitis who are willing to provide informed consent.
Not a fit: Patients with active infections, cancers, or other significant health issues may not benefit from this study.
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 performed: Previous studies have indicated that stem cell treatments can be safe and effective for inflammatory bowel diseases, suggesting a promising avenue for this approach.
Eligibility criteria
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 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.