NCT07041801

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

Phase I/II Clinical Study on the Safety, Efficacy, Pharmacodynamics and Immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection (hUCMSCs) in the Treatment of Patients With Moderate to Severe Systemic Lupus Erythematosus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Shenzhen Beike Bio-Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Inclusion criteria: 1. Fully understand the purpose, nature, methods of the trial, as well as possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form. 2. Age 18-65 years old (inclusive of the boundaries, based on the date of signing the informed consent form), regardless of gender; 3. The subjects (both male and female) must agree not to have a reproductive plan during the trial period and after the injection administration for at least 12 months, and voluntarily take effective contraceptive measures with their partners (see Appendix 1), and have no plans for sperm donation or egg donation; 4. According to the diagnostic classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) in 2019, diagnosed with systemic lupus erythematosus (SLE);

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-28
• Primary completion: 2027-09-05
• Completion: 2027-12-28
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: China