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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > 18 years and < 70 years.
- Diagnosis of Systemic Lupus Erythematosus (SLE) according to the ACR criteria with
positive antinuclear antibodies.
- Subjects with sustained disease activity defined by a SELENA- SLEDAI SLE activity
index = 6 at baseline,
- Inefficacy or adverse effects necessitating discontinuation of first and second line
therapies of SLE including:
a. Prednisone orally = 6 mg / day (or equivalent) for at least 28 days. b. At least
one or more of the following immunosuppressive therapies for 3 months in total: i-
Cyclophosphamide, iv bolus =500 mg / month for 3 months minimum ii- Mycophenolate
mofetil, orally or equivalent at a dose> 2000 mg / day for at least 90 days iii-
Azathioprine orally at a dose> 2 mg / kg / day for at least 90 days; iv- Methotrexate
orally or parenterally, at doses > 20mg / week for at least 90 days; v- Leflunomide
orally, at a dose of> 10-mg / day for at least 90 days; vi- Rituximab (anti-CD20)
intravenous bolus 375 mg / m2, once a week for four weeks or total dose of 1 g twice a
day for two weeks vii- Cyclosporine orally, at a dose of 2.5-5 mg / kg / day, for at
least 90 days; viii- Belimumab intravenously at monthly bolus of 10 mg / kg infusion),
for at least 3 months.
- Patient who received treatment of SLE at stable doses for a minimum of 30 days prior
to eligibility, including one of the following treatments: prednisone (or equivalent)
alone or combined with antimalarial treatment, an anti-inflammatory steroidal and / or
an immunosuppressant.
- Negative pregnancy test for women of childbearing age.
- For men and women : Using effective contraceptive methods during treatment and within
3 months after the end of treatment for men with her partner of childbearing age
- Signed Informed Consent.
- Affiliation to social security.
Exclusion Criteria:
1- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
- Presence of:
1. Renal failure: calculated creatinine clearance of <30 ml / min
2. Cardiac failure: clinical signs of congestive heart failure; left ventricular
ejection fraction <40% on echocardiography; uncontrolled ventricular arrhythmia;
3. Hepatitis defined by abnormal levels of transaminases (AST, ALT> 2 x normal) not
related to disease activity.
4. Respiratory disease: mean PAP> 50 mmHg (echocardiography), respiratory failure
defined by a resting blood pressure of oxygen at PaO 2 < 70 mmHg and / or PaCO2 >
50 mmHg without oxygen
- Severe psychiatric disorders, including severe psychosis related to SLE, which would
prevent to give informed consent or to undergo the procedure.
- Active neoplasia or concomitant myelodysplasia, except for basal cell carcinoma or
squamous cell carcinoma or in situ cervix carcinoma.
- Bone marrow failure defined by neutropenia <0.5.109/L, thrombocytopenia <30. 109 / L,
anemia < 8 g / dL, lymphopenia CD4 + <200 x 106 / L caused by another disease than
SLE.
- Acute or chronic uncontrolled infection: HIV 1/2, HTLV-1/2, Hepatitis B (HBsAg surface
antigen), Hepatitis C with positive PCR
- Patient having received belimumab within 2 months of belimumab within 2 months of
Baseline, or having received rituximab or other B cell depleting biologic therapy
within 6 months of Baseline
- Current substance abuse or recent (within 60 days) history of substance abuse
- Patient in periods of exclusion from the national roster of researchers
- Patient with Linguistic or psychological incapacity to sign informed consent
- Patient already included in another study at the same time.
- Poor patient compliance.
- Patient under legal protection.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Secondary Outcome(s)
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comorbidities Month 12
[Time Frame: 12 months]
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Proportion of subjects with Clinical Response Month 9
[Time Frame: 9 months]
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Steroids Month 12
[Time Frame: 12 months]
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Steroids Month 9
[Time Frame: 9 months]
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Toxicity of allogeneic MSC injection according to CTCAE Month 3
[Time Frame: 3 months]
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Toxicity of allogeneic MSC injection according to CTCAE Month 6
[Time Frame: 6 months]
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Disease activity measured by SELENA-SLEDAI Month 6
[Time Frame: 6 months]
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Disease activity measured by the BILAG index Month 3
[Time Frame: 3 months]
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Proportion of subjects with Clinical Response Month 6
[Time Frame: 6 months]
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Quality of life Month SF-36 Month 12
[Time Frame: 12 months]
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Disease activity measured by SELENA-SLEDAI Month 12
[Time Frame: 12 months]
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Disease activity measured by the BILAG index Month 6
[Time Frame: 6 months]
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Toxicity of allogeneic MSC injection according to CTCAE Month 1
[Time Frame: 1 month]
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Toxicity of allogeneic MSC injection according to CTCAE Month 12
[Time Frame: 12 months]
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Quality of life Month SF-36 Month 6
[Time Frame: 6 months]
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SRI Month 9
[Time Frame: 9 months]
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comorbidities Month 3
[Time Frame: 3 months]
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Disease activity measured by SELENA-SLEDAI Month 9
[Time Frame: 9 months]
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Quality of life EQ-5D Month 12
[Time Frame: 12 months]
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Steroids Month 3
[Time Frame: 3 months]
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comorbidities Month 9
[Time Frame: 9 months]
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Disease activity measured by SELENA-SLEDAI Month 3
[Time Frame: 3 months]
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comorbidities Month 6
[Time Frame: 6 months]
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Disease activity measured by the BILAG index Month 12
[Time Frame: 12 months]
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Quality of life EQ-5D Month 6
[Time Frame: 6 months]
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Quality of life Month SF-36 Month 9
[Time Frame: 9 months]
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Disease activity measured by the BILAG index Month 9
[Time Frame: 9 months]
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Proportion of subjects with Clinical Response Month 3
[Time Frame: 3 months]
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Quality of life Month SF-36 Month 3
[Time Frame: 3 months]
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SRI Month 3
[Time Frame: 3 months]
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Steroids Month 6
[Time Frame: 6 months]
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Proportion of subjects with Clinical Response Month 12
[Time Frame: 12 months]
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Quality of life EQ-5D Month 3
[Time Frame: 3 months]
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SRI Month 12
[Time Frame: 12 months]
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SRI Month 6
[Time Frame: 6 months]
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Quality of life EQ-5D Month 9
[Time Frame: 9 months]
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