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

Inflammatory Bowel Diseases Clinical Trial

Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Inflammatory Bowel Disease

Clinical Trial 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

Clinical Trial Description

Studies have shown that stem cell treatment is safe and efficacious for the treatment of inflammatory bowel disease (IBD). Patients with IBD will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05003947
Study type Interventional
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact
Status Recruiting
Phase Phase 1
Start date June 11, 2022
Completion date October 2025
View Details
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