Safety and Efficacy Study of hAESCs Therapy for aGVHD

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2025

Conditions
GVHD,Acute
Interventions
DRUG

Human Amniotic Epithelial Stem Cell Injection

"The dose escalation is carried out according to the 3+3 ascending principle, and a total of 3 dose levels are set:~1. Dose Level 1: 1×106 cells/kg;~2. Dose Level 2: 2×106 cells/kg;~3. Dose Level 3: 3×106 cells/kg; Note: In this study, if the maximum tolerated dose (MTD) is not explored at dose level 3 (3×106 cells/kg), it will be discussed by the Safety Review Committee (SRC) to decide whether to proceed with further dose escalation or expansion to 6 patients."

All Listed Sponsors
lead

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY