Safety Study of Intravenous Infusion of Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Treating Inflammatory Bowel Diseases

What this Trial Is About

This trial investigates the safety and effectiveness of a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for patients with inflammatory bowel disease IBD, including Crohns disease and Ulcerative Colitis. It is a Phase 1 interventional study sponsored by The Foundation for Orthopaedics and Regenerative Medicine. The study also includes patients with more severe disease who may receive an autologous T Cell vaccine made from their own T cells. Participants will receive a single infusion containing 100 million stem cells. Patients with severe IBD requiring chemotherapy drugs like methotrexate may be treated with an autologous T Cell vaccine created from their own cells collected by apheresis. The study does not involve a placebo or masking. Participants will be evaluated before treatment and then at 1, 6, 12, 24, 36, and 48 months after treatment to monitor safety and effectiveness. Safety will be assessed by tracking adverse events over four years. Effectiveness will be evaluated using the Short Inflammatory Bowel Disease Questionnaire SIBDQ during the same follow-up period. The total participation lasts up to four years with regular assessments.

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IBD