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

Inclusion Criteria:

1. Fully understand the purpose, nature, methods of the trial and possible adversereactions, 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 signingthe informed consent form), no gender restrictions;

3. The subjects (male and female) must agree not to have a reproductive plan during thetrial period and after the injection administration for at least 12 months, andvoluntarily 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 AgainstRheumatism (EULAR)/American College of Rheumatology (ACR) in 2019, diagnosed withsystemic 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 theanti-Sm antibody is positive during screening;

Exclusion Criteria:

1. Those who are judged by the researchers to be likely to be allergic to theinvestigational drug or any component thereof;

2. Those who have had central nervous system diseases within 8 weeks beforeadministration (including but not limited to epilepsy, mental illness, interstitialencephalopathy 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 asliver, kidney, hematological, endocrine, pulmonary, immune, mental, etc.) or activeinfections/infectious diseases with evidence, and according to the researchers'clinical judgment, if the subjects participate in the study, it will significantlyincrease 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 = 0.133kPa), or mild to moderate pulmonary arterial hypertension patients with severecardiopulmonary insufficiency;

7. Those who have antiphospholipid syndrome (APS), or have a history of catastrophicantiphospholipid syndrome (CAPS), or although not diagnosed as APS, but areevaluated by the researchers as having an increased risk of thrombosis;

8. Those who have herpes zoster infection within 90 days before administration, or anyinfection that requires hospitalization treatment or intravenous or intramuscularinjection of antibiotics within 60 days before administration;

9. Those who have undergone major surgical operations within 28 days beforeadministration, or those who are expected to undergo major surgical operationsduring the trial;

10. Subjects who have positive serological tests for viral hepatitis during thescreening period, positive human immunodeficiency virus antibody (HIV-Ab), positivehepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV-Ab), orpositive Treponema pallidum antibody (TP-Ab);

11. Other situations that the researchers consider may affect the subjects' willingnessto provide informed consent or follow the trial protocol, or situations where thesubjects' participation in the trial may affect the trial results or their ownsafety.