A Study of TH-SC01 for Treating Complex Perianal Fistula in Perianal Crohn's Disease.
NCT04939337 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2021-06-25
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.
Conditions
Interventions
- 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)
Sponsors & Collaborators
-
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Jinling Hospital, China
lead OTHER
Principal Investigators
-
Wei Juan, doctor · Jinling Hospital, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-12
- Primary Completion
- 2024-01-31
- Completion
- 2024-08-31
Countries
- China
Study Locations
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