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
Shenzhen Beike Bio-Technology Co., Ltd.
58 participants
Jun 28, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
patients will receive conventional therapy plus low dose hUC-MSCs treatment,The dosage is 1E6 cells/kg.
patients will receive conventional therapy plus medium dose hUC-MSCs treatment,The dosage is 3E6 cells/kg.
patients will receive conventional therapy plus high dose hUC-MSCs treatment,The dosage is 5E6 cells/kg.
patients will receive conventional therapy plus Placebo
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07041801