Systemic Lupus Erythematosus (SLE)Phase 1/2NCT07041801
Treatment of Systemic Lupus Erythematosus With Human Umbilical Cord Mesenchymal Stem Cells
A Phase 1/2 study testing hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose) and hUC-MSCs treatment (high dose) in people with Systemic Lupus Erythematosus (SLE), run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose) and hUC-MSCs treatment (high dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2025to 28 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
- 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);
- 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 cannot join
- Those who are judged by the researchers to be likely to be allergic to the investigational drug or any component thereof;
- 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.);
- Those who have undergone major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplantation;
- 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;
- Those who currently have known or suspected malignant tumors;
- 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;
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- 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;
- 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;
- 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;
- 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);
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen Beike Bio-Technology Co. Ltd.
Shenzhen, Guangdong, 518000
HU, +86-0755-86309200, guotao@beike.cc
ZHAN GUO LI
About this study
Official title: 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
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.
Read the detailed description
Inclusion criteria:
- Fully understand the purpose, nature, methods of the trial, as well as possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
- Age 18-65 years old (inclusive of the boundaries, based on the date of signing the informed consent form), regardless of gender;
- The subjects (both 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;
- According to the diagnostic classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) in 2019, diagnosed with systemic lupus erythematosus (SLE);
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose), hUC-MSCs treatment (high dose), Placebo, hUC-MSCs treatment （Double dose）
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUC-MSCs treatment (low dose)Drug
patients will receive conventional therapy plus low dose hUC-MSCs treatment,The dosage is 1E6 cells/kg.
hUC-MSCs treatment (medium dose)Biological
Also called MSC-medium
patients will receive conventional therapy plus medium dose hUC-MSCs treatment,The dosage is 3E6 cells/kg.
hUC-MSCs treatment (high dose)Biological
Also called MSC-high
patients will receive conventional therapy plus high dose hUC-MSCs treatment,The dosage is 5E6 cells/kg.
PlaceboDrug
patients will receive conventional therapy plus Placebo
hUC-MSCs treatment （Double dose）Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSCs treatment (low dose) | Experimental | Conventional plus hUC-MSCs treatment (low dose) Receives: Drug: hUC-MSCs treatment (low dose) |
| hUC-MSCs treatment （medium dose） | Experimental | conventional therapy plus hUC-MSCs treatment （medium dose） Receives: Biological: hUC-MSCs treatment (medium dose) |
| hUC-MSCs treatment （high dose） | Experimental | conventional therapy plus hUC-MSCs treatment （high dose） Receives: Biological: hUC-MSCs treatment (high dose) |
| hUC-MSCs treatment （Double dose） | Experimental | conventional therapy plus hUC-MSCs treatment（Double dose） Receives: Biological: hUC-MSCs treatment （Double dose） |
| Placebo | Placebo comparator | conventional therapy plus Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.
Measured: day 1 to day 28
Secondary outcomes (1)
Efficacy Endpoint
The proportion of subjects whose SLEDAI-2000 score (a scale for assessing the disease activity of systemic lupus erythematosus) decreased by ≥ 4 points Total score ranging from 0 to 105.
Interpretation: Scores are categorized to indicate disease activity:
0: No activity 1-5: Mild activity 6-10: Moderate activity 11-19: High activity
≥20: Very high activity
Improvement is defined as a decrease in score.
Measured: The 24th week after administration of the test drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start28 Jun 2025 (estimated)
- Primary completion5 Sep 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041801
- Sponsor's protocol ID
- BK-SLE-I/01
- Status last verified
- Jun 2025
- First submitted
- 27 Apr 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07041801
- Acronym / sponsor ID
- BK-SLE-I/01
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shenzhen Beike Bio-Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2025 (estimated)
- Primary completion
- 5 Sep 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inclusion criteria:
- Fully understand the purpose, nature, methods of the trial, as well as possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
- Age 18-65 years old (inclusive of the boundaries, based on the date of signing the informed consent form), regardless of gender;
- The subjects (both 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;
- According to the diagnostic classification criteria of the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) in 2019, diagnosed with systemic lupus erythematosus (SLE);
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| hUC-MSCs treatment (low dose) | Experimental | Drug: hUC-MSCs treatment (low dose)Conventional plus hUC-MSCs treatment (low dose) |
| hUC-MSCs treatment （medium dose） | Experimental | Biological: hUC-MSCs treatment (medium dose)conventional therapy plus hUC-MSCs treatment （medium dose） |
| hUC-MSCs treatment （high dose） | Experimental | Biological: hUC-MSCs treatment (high dose)conventional therapy plus hUC-MSCs treatment （high dose） |
| hUC-MSCs treatment （Double dose） | Experimental | Biological: hUC-MSCs treatment （Double dose）conventional therapy plus hUC-MSCs treatment（Double dose） |
| Placebo | Placebo comparator | Drug: Placeboconventional therapy plus Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- 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;
- 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);
- 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;
Key exclusion criteria (11 listed)
- Those who are judged by the researchers to be likely to be allergic to the investigational drug or any component thereof;
- 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.);
- Those who have undergone major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplantation;
- 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;
- Those who currently have known or suspected malignant tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hUC-MSCs treatment (low dose)patients will receive conventional therapy plus low dose hUC-MSCs treatment,The dosage is 1E6 cells/kg. | Drug | hUC-MSCs treatment (low dose) |
| hUC-MSCs treatment (medium dose)Also: MSC-mediumpatients will receive conventional therapy plus medium dose hUC-MSCs treatment,The dosage is 3E6 cells/kg. | Biological | hUC-MSCs treatment （medium dose） |
| hUC-MSCs treatment (high dose)Also: MSC-highpatients will receive conventional therapy plus high dose hUC-MSCs treatment,The dosage is 5E6 cells/kg. | Biological | hUC-MSCs treatment （high dose） |
| Placebopatients will receive conventional therapy plus Placebo | Drug | Placebo |
| 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. | Biological | hUC-MSCs treatment （Double dose） |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: day 1 to day 28
Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.
1 secondary outcome
Efficacy Endpoint
Time frame: The 24th week after administration of the test drug.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hUC-MSCs treatment (low dose), hUC-MSCs treatment (medium dose) and hUC-MSCs treatment (high dose) in people with Systemic Lupus Erythematosus (SLE), run by Shenzhen Beike Bio-Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: day 1 to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.