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

NCT07041801 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-06-27

No results posted yet for this study

Summary

This study will investigate the safety and efficacy of allogeneic umbilical cord-derived stem cell therapy in treating patients with moderate to severe systemic lupus erythematosus.

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.

Sponsors & Collaborators

  • Shenzhen Beike Bio-Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-28
Primary Completion
2027-09-05
Completion
2027-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07041801 on ClinicalTrials.gov