58
Participants
Start Date
June 28, 2025
Primary Completion Date
September 5, 2027
Study Completion Date
December 28, 2027
hUC-MSCs treatment (low dose)
patients will receive conventional therapy plus low dose hUC-MSCs treatment,The dosage is 1E6 cells/kg.
hUC-MSCs treatment (medium dose)
patients will receive conventional therapy plus medium dose hUC-MSCs treatment,The dosage is 3E6 cells/kg.
hUC-MSCs treatment (high dose)
patients will receive conventional therapy plus high dose hUC-MSCs treatment,The dosage is 5E6 cells/kg.
Placebo
patients will receive conventional therapy plus Placebo
hUC-MSCs treatment (Double dose)
Double dosing is selected by the investigators and the sponsor based on the data from the single-dose part of the study. One superior dose is chosen for multiple dosing (tentatively set at 3E6 cells/kg, administered twice with an interval of 4 weeks; the actual dose, frequency and interval of multiple dosing can be adjusted according to the available data). During the trial, stable standard treatment is allowed.
RECRUITING
Shenzhen Beike Bio-Technology Co. Ltd., Shenzhen
Shenzhen Beike Bio-Technology Co., Ltd.
INDUSTRY