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

PHASE1RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

September 21, 2022

Primary Completion Date

January 21, 2024

Study Completion Date

January 21, 2026

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."

Trial Locations (1)

210000

RECRUITING

Jinling Hospital, China, Nanjing

All Listed Sponsors
collaborator

Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

INDUSTRY

lead

Jinling Hospital, China

OTHER