NCT05003947 Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD
| NCT ID | NCT05003947 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2022-06-11 |
| Primary Completion | 2025-10 |
Trial Parameters
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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 inflammatory bowel disease
Eligibility 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