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A Study of TH-SC01 in the Treatment of Radiation-induced Rectal Injury

NCT05939778 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-07-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of allogeneic umbilical cord mesenchymal stem cells in the treatment of radiation-induced rectal injury.

Conditions

  • Rectal Injury

Interventions

BIOLOGICAL

TH-SC01(Umbilical cord mesenchymal stem cells)

"5+7" principle: 1\. In medium and high dose groups, 5 subjects were included in each dose group in the first step, and the first 3 subjects had good safety The investigator evaluated safety and efficacy data and could enroll a fourth and fifth subject. 1. If the number of successful participants in these 5 subjects is less than 2, the study in this dose group will be ended due to drug ineffectiveness, and the researcher will evaluate the safety and enter the next dose group. 2. If the number of successful participants in these 5 cases is greater than or equal to 2, then proceed to the second step. 2\. 7 subjects were included in the second step.

Sponsors & Collaborators

  • Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Jinling Hospital, China

    lead OTHER

Principal Investigators

  • Fangyu Wang · Director of gastroenterology Department, Jinling Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-01-21
Completion
2026-01-21

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 NCT05939778 on ClinicalTrials.gov