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EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective control in EBV infection and altered both B and T immune responses to this virus The main objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE
Systemic lupus is a disabling disease of the young woman, whose treatment is based on the long-term corticosteroid, anti-malarials and immunosuppressants synthesis. This support is not without potential side effects. EBV is a herpes causes infectious mononucleosis virus, usually encounter in childhood or adolescence, and that our natural immunity cell (CD8 T cells) controls all our lives, not eliminate.
Increasingly scientific studies show that there are patients with systemic lupus (and multiple sclerosis), a failure of self-control of the EBV virus, by T lymphocytes (CD8). This uncontrolled virus then stimulate the B lymphocytes, which produce antibodies, toxic in lupus. The laboratory isolate T cells specific for EBV (EBV-CTL) of a patient, and stimulate in culture to strengthen them. They can be then re-injected by a single intravenous infusion (autotransfusion), and were used to control the virus in certain diseases where EBV has a demonstrated role post-transplant lymphoproliferative disorder, chronic fatigue syndrome EBV-induced.
Our therapeutic approach is completely innovative, as based on the principle of cell therapy, thus not using new drugs, and based on the restoration of the patient's immune system, specific EBV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous EBV specific CTL infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous EBV specific CTL infusion | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| description of adverse events according CTC toxicity criteria . | Tolerance will be assessed by clinical and laboratory examinations to each Visit according to CTC toxicity criteria. | month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Lupus Erythematosus clinical activity | Composite Response of SLE Index (Systemic Lupus Erythematosus Responder Index: Systemic Lupus Erythematosus Disease Activity Index + British Isles Lupus Assessment Group + Physician Global Assessment) | day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Hamidou, PU PH | Nantes University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes - Dermatologie | Nantes | France | ||||
| CHU de Nantes - Médecine interne |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Quality of Life, The Short Form (36) Health Survey |
The Short Form (36) Health Survey |
| day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
| Lupus Quality of Life | Lupus Quality of Life questionnaire | day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
| Systemic Lupus Erythematosus biological activity (1) | biological parameter measurement biomarkers C3 | day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
| Systemic Lupus Erythematosus biological activity (2) | biological parameter measurement biomarkers C4 | day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
| Systemic Lupus Erythematosus biological activity (3) | biological parameter measurement biomarkers anti-dsDNA antibodies | day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
| Systemic Lupus Erythematosus biological activity (4) | biological parameter EBV blood load | day 0, day 10, week 4, month 3, month 6, month 9 and month 12 |
| Nantes |
| France |
| Hopital La pitié Salpétriere | Paris | France |