Actively Recruiting
Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells
Led by Shenzhen Beike Bio-Technology Co., Ltd. · Updated on 2025-06-27
58
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the purpose, nature, methods of the trial and possible adverse reactions, voluntarily become a subject, and sign the informed consent form.
- Age 18-65 years old (inclusive of the boundary values, based on the time of signing the informed consent form), no gender restrictions.
- Agree not to have a reproductive plan during the trial period and for at least 12 months after injection, and voluntarily take effective contraceptive measures with partners.
- Have no plans for sperm donation or egg donation during the trial and 12 months after.
- Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR criteria.
- Meet at least one of the following positive antibody conditions during screening: antinuclear antibody (ANA) at 1:80, anti-dsDNA antibody, or anti-Sm antibody positive.
You will not qualify if you...
- Likely to be allergic to the investigational drug or any component.
- History of central nervous system diseases within 8 weeks before administration (e.g., epilepsy, mental illness, stroke, encephalitis).
- Prior major organ transplantation or hematopoietic stem cell/marrow transplantation.
- Any major or unstable diseases or active infections that increase risk as judged by researchers.
- Known or suspected malignant tumors.
- Severe pulmonary arterial hypertension (>70 mmHg) or mild to moderate with severe cardiopulmonary insufficiency.
- Antiphospholipid syndrome (APS) or history of catastrophic APS or increased thrombosis risk.
- Herpes zoster infection within 90 days or infections requiring hospitalization or intravenous/intramuscular antibiotics within 60 days.
- Major surgical operations within 28 days before administration or planned during the trial.
- Positive serological tests for viral hepatitis, HIV, hepatitis B or C, or syphilis during screening.
- Any condition that may affect informed consent, protocol adherence, trial results, or participant safety as judged by researchers.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shenzhen Beike Bio-Technology Co. Ltd.
Shenzhen, Guangdong, China, 518000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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