NCT04939337

A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.

Study to Assess the Safety and Efficacy of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells(TH-SC01), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	TH-SC01	Allogeneic Umbilical Cord-derived Mesenchymal Stem cells perilesional injection. Human TH-SC01 cell injection (human umbilical cord mesenchymal stem cells for injection, 5 million cells / ml, 6.0-10.0ml / bottle)

Timeline

• Start date: 2020-11-12
• Primary completion: 2024-01-01
• Completion: 2024-08-01
• First posted: 2021-06-25
• Last updated: 2021-06-25

Locations

1 site across 1 country: China