Lupus NephritisPhase 2NCT03580291
Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN)
A Phase 2 study testing Mesenchymal stem cells and Mycophenolate Mofetil in people with Lupus Nephritis, run by Lingyun Sun at 1 site in China.
Trial summary
Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE).The investigators have investigated the usefulness, and confirmed the efficacy and safety of mesenchymal stem cells (MSC) treatment of LN in animal models, in vitro experiments… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Mesenchymal stem cells and Mycophenolate Mofetil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Jun 2021
- Phase
- Phase 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who met the American college of Rheumatology (ACR, 1997) classification criteria for SLE;
- Ages: 18-60 years old (including);
- Presence of class III, IV, V, III+V or IV+V LN as determined by renal biopsy within 12 weeks of randomization(2003 ISN/RPS LN classification criteria);
- Morning proteinuria /creatinine ratio >1.0 or 24 hours Proteinuria >1.0g, with or without microscopic hematuria(>5 red blood cells/high-power field);
- Women of childbearing age agreed to adopt effective contraception measures during the trial period;
- Urine pregnancy tests were negative in women of childbearing age;
- Subject signed the informed consent form voluntarily and complied with the requirements of the research program.
Who cannot join
- Received MMF, CTX, other potent immunosuppressive agents (including cyclosporine, tacrolimus, Tripterygium wilfordii and leflunomide) or biologics (Rituximab or others) within the past 12 weeks.
- Previous failure to respond to MMF.
- Known intolerance to MMF.
- Renal biopsy showing ≥50% glomerulus sclerosis.
- Renal biopsy showing capillary loops necrosis, microthrombus formation in capillary loops, or cellular crescent in ≥50% of glomeruli.
- Patients diagnosed with other autoimmune diseases apart from SLE: dermatomyositis/polymyositis, mixed connective tissue disease, scleroderma, rheumatoid arthritis, etc. However, participants with secondary Sjogren's syndrome are allowed to take part in the study.
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- Patients suffering from severe liver or kidney dysfunction (total bilirubin more than 14mg/L, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal lab value; creatinine clearance rate (Ccr) < 30ml/min or serum creatinine (Scr) ≥265.2umol/L).
- Patients with hematological abnormalities (white blood cell <3000/uL, hemoglobin <8g/dL, and/or platelets <50000/uL).
- Patients diagnosed with severe or uncontrolled cardiovascular, neurological, pulmonary (including obstructive pulmonary disease and interstitial lung disease), hepatic, endocrine (including uncontrolled diabetes mellitus), and gastrointestinal disorders.
- Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis, atypical mycobacterial infection, granulomatous disease showed by chest X-ray, hepatitis B, hepatitis C, HIV infection and herpes zoster, whereas not including onychomycosis). Any infection requiring hospitalization within 4 weeks prior to enrollment or intravenous antimicrobial treatment within 2 weeks prior to randomization.
- History of malignancy, including solid tumor and hematologic malignancies (except basal cell carcinoma which has been excised or successfully treated).
- Women who are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Lingyun Sun, M.D., +86(25)83106666 ext. 61421
About this study
Official title: A Randomized, Double-Blind, Parallel-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Patients With Lupus Nephritis
Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE).The investigators have investigated the usefulness, and confirmed the efficacy and safety of mesenchymal stem cells (MSC) treatment of LN in animal models, in vitro experiments and phase I clinical trial. In this study, a randomized, placebo-controlled, parallel group, non-inferiority, prospective, multicenter clinical trial is performed to investigate the efficacy and safety of MSC transplantation in the treatment of LN compared to mycophenolate mofetil (MMF).
Read the detailed description
Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE). Type III, type IV and type V LN are severe clinical entities with poor prognosis, and its treatment remains challenging. Currently, type III, type IV, type V, type III plus V and type IV plus V LN are treated mainly according to the guidelines developed by KDIGO and the European Association for Anti-Rheumatism and European League Against Rheumatism/European Renal Association-European Dialysis and Transplant Association (EULAR/ERAEDTA). The main therapeutic regimens recommended by these guidelines include glucocorticoid combined with immunosuppressants such as cyclophosphamide (CTX), mycophenolate mofetil (MMF), etc. These medications can significantly induce disease remission and improve the long-term survival. However, some patients do not adequately response to the treatment of the combination of steroids and immunosuppressants, and the disease activity cannot be well-controlled. The high prevalence of steroids and immunosuppressants related adverse effects, such as steroid-related diabetes, bone necrosis, hypertension, peptic ulcer, CTX-related bone marrow and gonadal suppression, MMF-related infection risk and so on, have been found in long-term follow-up study. In addition, to date, there is insufficient data to support the use of new biologics, such as rituximab and abatacept in the induction therapy in patients with LN.
Mesenchymal stem cells (MSCs) can be obtained from several tissues and possess multiple differentiation potencies and immunomodulatory effects. The investigators have investigated the usefulness, and confirmed the efficacy and safety of MSC treatment of LN in animal models, in vitro experiments and phase I clinical trial. The studies also for the first time found that the MSC abnormalities are involved in the onset and development of lupus both in the lupus mice model and in SLE patients. The investigators found that the efficacy of allogeneic (xenogeneic) MSC transplantation is superior to autologous MSC transplantation in LN mice model. Thus, in current opinion, SLE is not only a hematopoietic stem cell disease, but also a mesenchymal stem cell disease. The investigators treated the refractory LN patients with allogenic MSC treatment, the outcomes revealed that the total response rate was 60%, the mortality rate of 2 to 5 years decreased from 35% - 45% to 6%. These results strongly support the use of allogenic MSC transplantation in the refractory LN patients. The mechanisms of MSC treatment include correcting the immune unbalance, inducing immune tolerance, tissue repair and the improvement of organ function. Allogeneic MSC transplantation for the treatment of SLE and other refractory autoimmune diseases have shown significant efficacy and excellent safety. However, these studies have limitations due to the lack of large-scale, multi-center, randomized, controlled, prospective study to further confirm the efficacy of allogeneic MSC transplantation, as well as the guideline for MSC treatment in SLE needs to be developed. Therefore, a randomized, placebo-controlled, parallel group, non-inferiority, prospective, multicenter clinical trial is urgent needed to promote the application of MSC transplantation in SLE treatment, to bring the benefit of the patients with SLE.
- Conditions
- Lupus Nephritis
- Being tested
- Mesenchymal stem cells, Mycophenolate Mofetil, Placebo of Mesenchymal stem cells, Placebo of Mycophenolate Mofetil
- Keywords
- Lupus Nephritis, Mesenchymal stem cell
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsOther
The group receive pulse infusion of MSCs once of 2 x 10^6/kg body weight
This group receive oral MMF of 2.0 g / d.
Placebo of Mesenchymal stem cellsOther
The group receive placebo of Mesenchymal stem cells.
Placebo of Mycophenolate MofetilDrug
The group receive placebo of oral mycophenolate mofetil.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | The group receive pulse infusion of MSCs and placebo of oral Mycophenolate Mofetil (MMF). The cells of 2 x 10^6/kg body weight are suspended in 100ml saline and infused intravenously.
1. Dexamethasone of 10mg is intravenously injected before 30 minutes of cells infusion.
2. A sterile blood transfusion device is used during the venous transfusion, and it is washed with saline before infusion. Take a slow infusion of about 20 drops per minute in the first 15 minutes. Increase to about 60 drops per minute if the patient had no complaints of discomfort. Receives: Other: Mesenchymal stem cells; Drug: Placebo of Mycophenolate Mofetil |
| Mycophenolate Mofetil | Active comparator | The group receive placebo of MSCs and oral Mycophenolate Mofetil of 2.0g/d. . Receives: Drug: Mycophenolate Mofetil; Other: Placebo of Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total remission rate
Complete remission rate (CR) and partial remission rate (PR)
Measured: weeks 24
Secondary outcomes (17)
The time for subjects of the two groups to achieve PR and CR
Measured: Baseline to weeks 24
Levels of 24-hour urinary protein
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Ratio of Urinary Protein / Creatinine
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of serum albumin
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of serum creatinine
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
The estimated glomerular filtration rate ( eGFR )
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of Complement component 3 (C3)
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of Complement component 4 (C4)
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
The antinuclear antibody (ANA) levels
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
The anti-double stranded DNA antibody (dsDNA) levels
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Patient Health Assessment Questionnaire (HAQ) score
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Physician Global Assessment (PhGA) score
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
The (Systemic lupus Erythematosis Disease Activity index) SLEDAI score
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
The (British Isles lupus assessment group ) BILAG score
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
The SLE reaction index
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24
Total remission rate
Complete remission rate (CR) and partial remission rate (PR)
Measured: weeks 12
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Baseline to weeks 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingyun Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingyun Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580291
- Sponsor's protocol ID
- 2017001
- Status last verified
- Jul 2018
- First submitted
- 12 Jan 2018
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Patients With Lupus Nephritis
- ClinicalTrials.gov ID
- NCT03580291
- Acronym / sponsor ID
- 2017001
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, Mesenchymal stem cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Lingyun SunUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 9 Jul 2018 (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.
Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE).The investigators have investigated the usefulness, and confirmed the efficacy and safety of mesenchymal stem cells (MSC) treatment of LN in animal models, in vitro experiments and phase I clinical trial. In this study, a randomized, placebo-controlled, parallel group, non-inferiority, prospective, multicenter clinical trial is performed to investigate the efficacy and safety of MSC transplantation in the treatment of LN compared to mycophenolate mofetil (MMF).
Detailed description
Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE). Type III, type IV and type V LN are severe clinical entities with poor prognosis, and its treatment remains challenging. Currently, type III, type IV, type V, type III plus V and type IV plus V LN are treated mainly according to the guidelines developed by KDIGO and the European Association for Anti-Rheumatism and European League Against Rheumatism/European Renal Association-European Dialysis and Transplant Association (EULAR/ERAEDTA). The main therapeutic regimens recommended by these guidelines include glucocorticoid combined with immunosuppressants such as cyclophosphamide (CTX), mycophenolate mofetil (MMF), etc. These medications can significantly induce disease remission and improve the long-term survival. However, some patients do not adequately response to the treatment of the combination of steroids and immunosuppressants, and the disease activity cannot be well-controlled. The high prevalence of steroids and immunosuppressants related adverse effects, such as steroid-related diabetes, bone necrosis, hypertension, peptic ulcer, CTX-related bone marrow and gonadal suppression, MMF-related infection risk and so on, have been found in long-term follow-up study. In addition, to date, there is insufficient data to support the use of new biologics, such as rituximab and abatacept in the induction therapy in patients with LN.
Mesenchymal stem cells (MSCs) can be obtained from several tissues and possess multiple differentiation potencies and immunomodulatory effects. The investigators have investigated the usefulness, and confirmed the efficacy and safety of MSC treatment of LN in animal models, in vitro experiments and phase I clinical trial. The studies also for the first time found that the MSC abnormalities are involved in the onset and development of lupus both in the lupus mice model and in SLE patients. The investigators found that the efficacy of allogeneic (xenogeneic) MSC transplantation is superior to autologous MSC transplantation in LN mice model. Thus, in current opinion, SLE is not only a hematopoietic stem cell disease, but also a mesenchymal stem cell disease. The investigators treated the refractory LN patients with allogenic MSC treatment, the outcomes revealed that the total response rate was 60%, the mortality rate of 2 to 5 years decreased from 35% - 45% to 6%. These results strongly support the use of allogenic MSC transplantation in the refractory LN patients. The mechanisms of MSC treatment include correcting the immune unbalance, inducing immune tolerance, tissue repair and the improvement of organ function. Allogeneic MSC transplantation for the treatment of SLE and other refractory autoimmune diseases have shown significant efficacy and excellent safety. However, these studies have limitations due to the lack of large-scale, multi-center, randomized, controlled, prospective study to further confirm the efficacy of allogeneic MSC transplantation, as well as the guideline for MSC treatment in SLE needs to be developed. Therefore, a randomized, placebo-controlled, parallel group, non-inferiority, prospective, multicenter clinical trial is urgent needed to promote the application of MSC transplantation in SLE treatment, to bring the benefit of the patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells | Experimental | Other: Mesenchymal stem cells, Drug: Placebo of Mycophenolate MofetilThe group receive pulse infusion of MSCs and placebo of oral Mycophenolate Mofetil (MMF). The cells of 2 x 10^6/kg body weight are suspended in 100ml saline and infused intravenously. 1. Dexamethasone of 10mg is intravenously injected before 30 minutes of cells infusion. 2. A sterile blood transfusion device is used during the venous transfusion, and it is washed with saline before infusion. Take a slow infusion of about 20 drops per minute in the first 15 minutes. Increase to about 60 drops per minute if the patient had no complaints of discomfort. |
| Mycophenolate Mofetil | Active comparator | Drug: Mycophenolate Mofetil, Other: Placebo of Mesenchymal stem cellsThe group receive placebo of MSCs and oral Mycophenolate Mofetil of 2.0g/d. . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who met the American college of Rheumatology (ACR, 1997) classification criteria for SLE;
- Ages: 18-60 years old (including);
- Presence of class III, IV, V, III+V or IV+V LN as determined by renal biopsy within 12 weeks of randomization(2003 ISN/RPS LN classification criteria);
- Morning proteinuria /creatinine ratio >1.0 or 24 hours Proteinuria >1.0g, with or without microscopic hematuria(>5 red blood cells/high-power field);
- Women of childbearing age agreed to adopt effective contraception measures during the trial period;
Key exclusion criteria (12 listed)
- Received MMF, CTX, other potent immunosuppressive agents (including cyclosporine, tacrolimus, Tripterygium wilfordii and leflunomide) or biologics (Rituximab or others) within the past 12 weeks.
- Previous failure to respond to MMF.
- Known intolerance to MMF.
- Renal biopsy showing ≥50% glomerulus sclerosis.
- Renal biopsy showing capillary loops necrosis, microthrombus formation in capillary loops, or cellular crescent in ≥50% of glomeruli.
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 |
|---|---|---|
| Mesenchymal stem cellsThe group receive pulse infusion of MSCs once of 2 x 10^6/kg body weight | Other | Mesenchymal stem cells |
| Mycophenolate MofetilThis group receive oral MMF of 2.0 g / d. | Drug | Mycophenolate Mofetil |
| Placebo of Mesenchymal stem cellsThe group receive placebo of Mesenchymal stem cells. | Other | Mycophenolate Mofetil |
| Placebo of Mycophenolate MofetilThe group receive placebo of oral mycophenolate mofetil. | Drug | Mesenchymal stem cells |
Primary outcome
Total remission rate
Time frame: weeks 24
Complete remission rate (CR) and partial remission rate (PR)
17 secondary outcomes
The time for subjects of the two groups to achieve PR and CR
Time frame: Baseline to weeks 24
Levels of 24-hour urinary protein
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Ratio of Urinary Protein / Creatinine
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of serum albumin
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of serum creatinine
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
The estimated glomerular filtration rate ( eGFR )
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of Complement component 3 (C3)
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Levels of Complement component 4 (C4)
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
The antinuclear antibody (ANA) levels
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
The anti-double stranded DNA antibody (dsDNA) levels
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Patient Health Assessment Questionnaire (HAQ) score
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Physician Global Assessment (PhGA) score
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
The (Systemic lupus Erythematosis Disease Activity index) SLEDAI score
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
The (British Isles lupus assessment group ) BILAG score
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
The SLE reaction index
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24
Total remission rate
Time frame: weeks 12
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Baseline to weeks 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal stem cells and Mycophenolate Mofetil in people with Lupus Nephritis, run by Lingyun Sun 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 12 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 10 Jul 2018. 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 phase mean?
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 Lingyun Sun, Ph.D M.D. (+86(025)83106666 ext. 61421, lingyunsun@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total remission rate (time frame: weeks 24). 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 10 Jul 2018.