Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

June 28, 2025

Primary Completion Date

September 5, 2027

Study Completion Date

December 28, 2027

Conditions
Systemic Lupus Erythematosus (SLE)
Interventions
DRUG

hUC-MSCs treatment (low dose)

patients will receive conventional therapy plus low dose hUC-MSCs treatment,The dosage is 1E6 cells/kg.

BIOLOGICAL

hUC-MSCs treatment (medium dose)

patients will receive conventional therapy plus medium dose hUC-MSCs treatment,The dosage is 3E6 cells/kg.

BIOLOGICAL

hUC-MSCs treatment (high dose)

patients will receive conventional therapy plus high dose hUC-MSCs treatment,The dosage is 5E6 cells/kg.

DRUG

Placebo

patients will receive conventional therapy plus Placebo

BIOLOGICAL

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.

Trial Locations (1)

518000

RECRUITING

Shenzhen Beike Bio-Technology Co. Ltd., Shenzhen

All Listed Sponsors
lead

Shenzhen Beike Bio-Technology Co., Ltd.

INDUSTRY

NCT07041801 - Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells | Biotech Hunter | Biotech Hunter