Systemic Lupus Erythematosus (SLE) Clinical Trial
Official title:
A Single - Arm Open - Label Study to Evaluate the Safety, Tolerability and Short Term Efficacy of Extracorporeal Specific Immunoadsorption LupusorbTM Columns for the Treatment of Systemic Lupus Erythematosus (SLE) Patients
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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