NCT07041801 Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells
| NCT ID | NCT07041801 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Beike Bio-Technology Co., Ltd. |
| Condition | Systemic Lupus Erythematosus (SLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2025-06-28 |
| Primary Completion | 2027-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 58 participants in total. It began in 2025-06-28 with a primary completion date of 2027-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT07041801 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erythematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07041801 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07041801 currently recruiting?
Yes, NCT07041801 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shenzhen Beike Bio-Technology Co., Ltd. to inquire about joining.
Where is the NCT07041801 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07041801 clinical trial?
NCT07041801 is sponsored by Shenzhen Beike Bio-Technology Co., Ltd.. The trial plans to enroll 58 participants.
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