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Systemic Lupus Erythematosus (SLE) is a chronic, autoimmune, inflammatory disease primarily affecting women of childbearing age, and associated with severe morbidity and mortality of its victims. The existing therapy, however, is not specific and its inevitable side effects may themselves be fatal. Therefore, it is a widely recognized need for, and it would be highly advantageous to have a safe, specific rapidly effective and well-defined treatment of SLE, devoid of the disadvantages.
We have shown that VRT101 a peptide present in the extracellular laminin is a target for pathogenic lupus autoantibodies. Using this peptide we have developed the LupusorbTM - an immune-adsorption column which specifically binds pathogenic antibodies from monoclonal cultures as well as from patients' plasma. The investigational product named LupusorbTM Column is a sterile medical device for single use and can be classified into category IIb (synthetic ligands, peptides) according to Annex IX of the European Medical Device Directive 42/93/EEC.
The proposed study, a pilot non-randomized open label study, will test the safety, Tolerability and short term efficacy of a single immunoadsorption procedure in SLE patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single arm open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LupusorbTM | Device | Single treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment- Patient's physical examination, vital signs (HR, BP, RR, Rhythm status), lab tests- hematology, CBC & blood biochemistry, Serology panel, anti VRT101 levels, liver and kidney function, urinalysis and SLE serological markers. | Within 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessment- SLE severity, CBC with differential, ESR, CRP, Blood biochemistry: Serum albumin, Serum Igs, Serology panel: ANA, direct Coomb's; C3, C4, anti-DNA and Serum anti-VRT 101 level and SF 36 Health questionnaire. | within 2 month |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study if ANY of the following conditions are present:
Patient has Severe proliferative lupus nephritis:
Patient Begin immunosuppressive therapy recently:
Patient suffers an active or chronic infection.
If female, reports pregnancy, breast-feeding (or inadequate birth control)
Confounding medical illness that in the judgment of investigators would pose.
Added risk for study participants such as:
Participation in another clinical trial within 2 months prior to start of this study.
Subject unwilling or unable to comply with the requirements of the protocol.
Any condition that the investigator feels would interfere with trial participation and evaluation of the results.
Subject unwilling and unable to provide inform consent.
Subjects receiving ACE inhibitors treatment 7 days prior to plasmapheresis procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Ein- Kerem | Jerusalem | 91120 | Israel |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2009 | |
| Reset | Feb 10, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2009 | Feb 10, 2009 |
| 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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