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The Purpose of This Study is to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula

NCT05677672 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-01-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas

Conditions

  • Complex Perianal Fistulas

Interventions

BIOLOGICAL

Human TH-SC01 Cell Injection

Single injection of 0.6×10\^7,1.2×10\^8, 1.8×10\^8 cells/kg

OTHER

Saline solution

saline solution will be given at the same quantity and following the same schedule

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2023-08-30
Completion
2023-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677672 on ClinicalTrials.gov