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Clinical Trial Summary

The purpose of this study is to asses the efficacy and Safety of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Complex Perianal Fistula in Perianal Crohn's Disease.


Clinical Trial Description

Crohn´s disease (CD) can affect any part of the digestive system and symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting and diarrhea. CD also causes bowel wall ulcers, strictures and fistulas (abnormal passages from the intestines to another organ or the skin). There is an unmet need for effective medical therapy in CD patients with perianal fistulas, not responding to the conventional strategies, including biological therapies. The current study is designed to assess the safety and efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem cells from healthy donors for the treatment of perianal fistulas in patients presenting CD. Primary objective: To assess the safety (incidence of treatment emergent adverse-events) of TH-SC01 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04939337
Study type Interventional
Source Jinling Hospital, China
Contact
Status Enrolling by invitation
Phase Phase 1
Start date November 12, 2020
Completion date August 2024

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