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

Launched by SHENZHEN BEIKE BIO-TECHNOLOGY CO., LTD. · Jun 19, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment for people with moderate to severe systemic lupus erythematosus (SLE), which is an autoimmune disease where the body’s immune system attacks its own tissues. The treatment uses special stem cells taken from donated umbilical cords to see if they are safe and helpful in controlling the disease. This is an early-phase study, meaning the main goal is to find out if the treatment is safe for patients and to gather initial information on how well it might work.

People who may join the study are adults between 18 and 65 years old who have been diagnosed with SLE based on specific medical tests. They need to understand the study and agree to participate voluntarily. Participants must also agree not to try to have children during the study and for a year after, to avoid any risks to a pregnancy. The study is open to all genders, but some people won’t be able to join, such as those with certain infections, recent major surgeries, other serious health problems, or a history of organ transplants. If you take part, you can expect close monitoring by the medical team to watch for any side effects and to see how your disease responds to this new stem cell treatment.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Fully understand the purpose, nature, methods of the trial and possible adverse reactions, voluntarily become a subject, and sign the informed consent form.
• • 2. Age 18-65 years old (inclusive of the boundary values, based on the time of signing the informed consent form), no gender restrictions;
• • 3. The subjects (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)/American College of Rheumatology (ACR) in 2019, diagnosed with systemic lupus erythematosus (SLE);
• • 5. Meet one of the following conditions: the antinuclear antibody (ANA) is positive at 1:80 during screening or the anti-dsDNA antibody is positive during screening or the anti-Sm antibody is positive during screening;
• Exclusion Criteria:
• • 1. Those who are judged by the researchers to be likely to be allergic to the investigational drug or any component thereof;
• • 2. Those who have had central nervous system diseases within 8 weeks before administration (including but not limited to epilepsy, mental illness, interstitial encephalopathy syndrome, stroke, encephalitis, central nervous system vasculitis, etc.);
• • 3. Those who have undergone major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplantation;
• • 4. Those who have any major diseases/diseases or unstable clinical conditions (such as liver, kidney, hematological, endocrine, pulmonary, immune, mental, etc.) or active infections/infectious diseases with evidence, and according to the researchers' clinical judgment, if the subjects participate in the study, it will significantly increase the risks for the subjects;
• • 5. Those who currently have known or suspected malignant tumors;
• • 6. Those who have severe pulmonary arterial hypertension (\>70 mmHg, 1 mmHg = 0.133 kPa), or mild to moderate pulmonary arterial hypertension patients with severe cardiopulmonary insufficiency;
• • 7. Those who have antiphospholipid syndrome (APS), or have a history of catastrophic antiphospholipid syndrome (CAPS), or although not diagnosed as APS, but are evaluated by the researchers as having an increased risk of thrombosis;
• • 8. Those who have herpes zoster infection within 90 days before administration, or any infection that requires hospitalization treatment or intravenous or intramuscular injection of antibiotics within 60 days before administration;
• • 9. Those who have undergone major surgical operations within 28 days before administration, or those who are expected to undergo major surgical operations during the trial;
• • 10. Subjects who have positive serological tests for viral hepatitis during the screening period, positive human immunodeficiency virus antibody (HIV-Ab), positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV-Ab), or positive Treponema pallidum antibody (TP-Ab);
• • 11. Other situations that the researchers consider may affect the subjects' willingness to provide informed consent or follow the trial protocol, or situations where the subjects' participation in the trial may affect the trial results or their own safety.