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.
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);
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
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.
Shenzhen Beike Bio-Technology Co. Ltd.
Shenzhen, Guangdong, China
RECRUITINGIncidence of Treatment-Emergent Adverse Events
Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.
Time frame: day 1 to day 28
Efficacy Endpoint
The proportion of subjects whose SLEDAI-2000 score (a scale for assessing the disease activity of systemic lupus erythematosus) decreased by ≥ 4 points Total score ranging from 0 to 105. Interpretation: Scores are categorized to indicate disease activity: 0: No activity 1-5: Mild activity 6-10: Moderate activity 11-19: High activity ≥20: Very high activity Improvement is defined as a decrease in score.
Time frame: The 24th week after administration of the test drug.
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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.