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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Phase I/II Clinical Study on the Safety, Efficacy, Pharmacodynamics and Immunogenicity of Human Umbilical Cord Mesenchymal Stem Cell Injection (hUCMSCs) in the Treatment of Patients With Moderate to Severe Systemic Lupus Erythematosus

Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells (NCT07041801) is a Phase 1 / Phase 2 interventional studying Systemic Lupus Erythematosus (SLE), sponsored by Shenzhen Beike Bio-Technology Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Systemic Lupus Erythematosus (SLE), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 58 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Systemic Lupus Erythematosus (SLE) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Fully understand the purpose, nature, methods of the trial and possible adverse reactions, voluntarily become a subject, and sign the willing to sign a consent form form. 2. Age 18-65 years old (inclusive of the boundary values, based on the time of signing the willing to sign a consent form 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; Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

hUC-MSCs treatment (low dose)

patients will receive conventional therapy plus low dose hUC-MSCs treatment,The dosage is 1E6 cells/kg.

BIOLOGICAL

hUC-MSCs treatment (medium dose)

patients will receive conventional therapy plus medium dose hUC-MSCs treatment,The dosage is 3E6 cells/kg.

BIOLOGICAL

hUC-MSCs treatment (high dose)

patients will receive conventional therapy plus high dose hUC-MSCs treatment,The dosage is 5E6 cells/kg.

DRUG

Placebo

patients will receive conventional therapy plus Placebo

BIOLOGICAL

hUC-MSCs treatment (Double dose)

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shenzhen Beike Bio-Technology Co. Ltd.
Shenzhen, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07041801), the sponsor (Shenzhen Beike Bio-Technology Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07041801 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07041801?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07041801?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07041801. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07041801. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.