Refractory Systemic Lupus ErythematosusPhase 1/2NCT00698191
Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)
A Phase 1/2 study testing Allogeneic MSC (AlloMSC) in people with Refractory Systemic Lupus Erythematosus, run by Nanjing Medical University at 1 site in China.
Trial summary
This study will explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of cells with capability to restore a normal immune system that will no longer attack the body. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Refractory Systemic Lupus Erythematosus
- What is being tested?
- Allogeneic MSC (AlloMSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
- Lupus nephritis with 24h urine protein≥1g;
- Refractory disease as determined by failure of the following regimens:
- Trial of corticosteroids (oral prednisone more than 20 mg/day);
- Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as MMF 2 g / day, for three months;
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
- Willing to use contraception throughout the study and for 12 mos following treatment.
Who cannot join
- Abnormal liver function (ALT higher than 3 times the normal value);
- End-stage renal failure;
- Severe heart and pulmonary failure, or other important organs damage;
- Undercontrolled infections
- Pregnant or breast feeding women, male or female who intended to recent pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Nanjing University Medical College Affiliated Drum Tower Hospital
Nanjing, Jiangsu, 210008
Sun Lingyun, MD, +86 25 83105219, lingyunsun2001@yahoo.com.cn
About this study
Official title: Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus
This study will explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of cells with capability to restore a normal immune system that will no longer attack the body.
The stated hypothesis is that the SLE condition is caused by an abnormal immune system that can be restored by replenishing the body with a new population of progenitor cells.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell (AlloMSC) transplantation in patients with refractory SLE. Patients with Lupus nephritis and refractory to corticosteroid or cyclophosphamide trials will be enrolled in this trial. The treatment intervention includes a 24 hour pretreatment with cyclophosphamide followed by AlloMSC transplantation. Patients will be admitted to the in-patient service for the 3-5 days for the transplant treatment and will be followed up in the outpatient clinic. All baseline lupus serology, renal function panels will be obtained at pre-treatment admission. Post-transplantation follow-up visits will be at monthly intervals for lupus serology and renal function tests, and every 3 months for analysis of T regulatory population. The transplanted patients will be evaluated by an integrated team of rheumatologists, hematologists and bone marrow transplant specialists every month for the entire duration of the trial (2 years) and every 6-12 months thereafter.
- Conditions
- Refractory Systemic Lupus Erythematosus
- Being tested
- Allogeneic MSC (AlloMSC)
- Keywords
- Lupus Erythematosus,Systemic, Lupus Nephritis, Mesenchymal Stem Cells, Transplantation
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic MSC (AlloMSC)Biological
Intervention:
Cyclophosphamide will be administered intravenously at at total dose of 0.8-1.8g 24 hours before transplantation.
Allogeneic bone marrow derived mesenchymal stem cells (matched family donors)will be infused intravenously at 106 cells/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Allogeneic MSC (AlloMSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Measured: Monthly
Lupus serology (ANA, dsDNA, C3, C4)
Measured: Monthly
Renal function (GFR, BUN, urinalysis)
Measured: Monthly
Secondary outcomes (1)
Percentage of systemic T regulatory population
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Refractory Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Investigators
- Lingyun Sun, M.D., Study director, Nanjing University Medical College Affiliated Drum Tower Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698191
- Sponsor's protocol ID
- NSFC30772014
- Status last verified
- Jun 2008
- First submitted
- 13 Jun 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang B, Sun L, Hao S, Li X, Xu Y, Hou Y. Estrogen modulates bone marrow-derived DCs in SLE murine model-(NZB x NZW) F1 female mice. Immunol Invest. 2008;37(3):227-43. doi: 10.1080/08820130801973328.
PubMed 18389442Jiang B, Sun L, Hao S, Li X, Hou Y. Estrogen distinctively modulates spleen DC from (NZB x NZW) F1 female mice in various disease development stages. Cell Immunol. 2007 Aug;248(2):95-102. doi: 10.1016/j.cellimm.2007.10.004. Epub 2007 Dec 3.
PubMed 18061155Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8. doi: 10.1177/0961203306075793.
PubMed 17402368Zheng Y, Liu S, Zeng L, Luo Y, Jin Z, Yang D, Shi Y, Li J, Wang H, Feng X, Wang D, Sun L. Allogeneic umbilical cord-derived mesenchymal stromal cells for treatment of refractory lupus nephritis: a real-world study. Stem Cell Res Ther. 2026 Apr 18;17(1):201. doi: 10.1186/s13287-026-05021-5.
PubMed 42001190Liang J, Zhang H, Kong W, Deng W, Wang D, Feng X, Zhao C, Hua B, Wang H, Sun L. Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study. Stem Cell Res Ther. 2018 Nov 14;9(1):312. doi: 10.1186/s13287-018-1053-4.
PubMed 30428931
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00698191
- Acronym / sponsor ID
- NSFC30772014
- Conditions
- Refractory Systemic Lupus Erythematosus
- Keywords
- Lupus Erythematosus,Systemic, Lupus Nephritis, Mesenchymal Stem Cells, Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Mar 2007
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 17 Jun 2008 (estimated)
- 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 explore a new approach to treat patients with a medical condition known as systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new population of cells with capability to restore a normal immune system that will no longer attack the body.
The stated hypothesis is that the SLE condition is caused by an abnormal immune system that can be restored by replenishing the body with a new population of progenitor cells.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell (AlloMSC) transplantation in patients with refractory SLE. Patients with Lupus nephritis and refractory to corticosteroid or cyclophosphamide trials will be enrolled in this trial. The treatment intervention includes a 24 hour pretreatment with cyclophosphamide followed by AlloMSC transplantation. Patients will be admitted to the in-patient service for the 3-5 days for the transplant treatment and will be followed up in the outpatient clinic. All baseline lupus serology, renal function panels will be obtained at pre-treatment admission. Post-transplantation follow-up visits will be at monthly intervals for lupus serology and renal function tests, and every 3 months for analysis of T regulatory population. The transplanted patients will be evaluated by an integrated team of rheumatologists, hematologists and bone marrow transplant specialists every month for the entire duration of the trial (2 years) and every 6-12 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Allogeneic MSC (AlloMSC) |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
- Lupus nephritis with 24h urine protein≥1g;
- Refractory disease as determined by failure of the following regimens:
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
- Willing to use contraception throughout the study and for 12 mos following treatment.
Key exclusion criteria (5 listed)
- Abnormal liver function (ALT higher than 3 times the normal value);
- End-stage renal failure;
- Severe heart and pulmonary failure, or other important organs damage;
- Undercontrolled infections
- Pregnant or breast feeding women, male or female who intended to recent pregnancy.
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 |
|---|---|---|
| Allogeneic MSC (AlloMSC)Intervention: Cyclophosphamide will be administered intravenously at at total dose of 0.8-1.8g 24 hours before transplantation. Allogeneic bone marrow derived mesenchymal stem cells (matched family donors)will be infused intravenously at 106 cells/kg body weight | Biological | 1 |
Primary outcome
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time frame: Monthly
Lupus serology (ANA, dsDNA, C3, C4)
Time frame: Monthly
Renal function (GFR, BUN, urinalysis)
Time frame: Monthly
1 secondary outcome
Percentage of systemic T regulatory population
Time frame: Every 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
- Background: PubMed 18389442Jiang B, Sun L, Hao S, Li X, Xu Y, Hou Y. Estrogen modulates bone marrow-derived DCs in SLE murine model-(NZB x NZW) F1 female mice. Immunol Invest. 2008;37(3):227-43. doi: 10.1080/08820130801973328.
- Background: PubMed 18061155Jiang B, Sun L, Hao S, Li X, Hou Y. Estrogen distinctively modulates spleen DC from (NZB x NZW) F1 female mice in various disease development stages. Cell Immunol. 2007 Aug;248(2):95-102. doi: 10.1016/j.cellimm.2007.10.004. Epub 2007 Dec 3.
- Background: PubMed 17402368Sun LY, Zhang HY, Feng XB, Hou YY, Lu LW, Fan LM. Abnormality of bone marrow-derived mesenchymal stem cells in patients with systemic lupus erythematosus. Lupus. 2007;16(2):121-8. doi: 10.1177/0961203306075793.
- Derived from this study: PubMed 42001190Zheng Y, Liu S, Zeng L, Luo Y, Jin Z, Yang D, Shi Y, Li J, Wang H, Feng X, Wang D, Sun L. Allogeneic umbilical cord-derived mesenchymal stromal cells for treatment of refractory lupus nephritis: a real-world study. Stem Cell Res Ther. 2026 Apr 18;17(1):201. doi: 10.1186/s13287-026-05021-5.
- Derived from this study: PubMed 30428931Liang J, Zhang H, Kong W, Deng W, Wang D, Feng X, Zhao C, Hua B, Wang H, Sun L. Safety analysis in patients with autoimmune disease receiving allogeneic mesenchymal stem cells infusion: a long-term retrospective study. Stem Cell Res Ther. 2018 Nov 14;9(1):312. doi: 10.1186/s13287-018-1053-4.
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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. This study is not recruiting at the moment.
Lingyun Sun, M.D. study director
Nanjing University Medical College Affiliated Drum Tower Hospital
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 Allogeneic MSC (AlloMSC) in people with Refractory Systemic Lupus Erythematosus, run by Nanjing Medical University 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jun 2008. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Lingyun, MD (+86 25 83105219, lingyunsun2001@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) (time frame: Monthly). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00698191, which also lists 5 linked publications.
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 17 Jun 2008.