Type 1 Diabetes Mellitus Clinical Trial
Official title:
Efalizumab (Raptiva) Combined With Sirolimus in Type 1 Diabetic Islet Allograft Recipients
The primary objective of this protocol is to test the safety and efficacy of a treatment
regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed
by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the
destruction and rejection of islet transplants in type 1 diabetic recipients.
Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market
in April of 2009. Previously transplanted subjects have been transitioned to alternative
immunosuppressives and no new subjects will be transplanted under this protocol.
The purpose of this study is to improve the applicability of islet transplantation for
treatment of type 1 diabetes utilizing a novel immunosuppressive regimen centered on the use
of adhesion molecule blockade with an anti-LFA-1 antibody (efalizumab). The
lymphocyte-function associated antigen-1 (LFA-1) adhesion molecule is expressed on multiple
cellular populations including T cells, B cells, and NK cells and is important in
facilitating cell migration and homing. In addition, interaction of LFA-1 with its ligand
ICAM-1 on antigen presenting cells provides a powerful costimulatory signal for T cell
activation.
Animal models using anti-LFA-1 antibodies have shown impressive prolongation of vascularized
and cellular allograft survival. These potent immunosuppressive properties have also been
documented in several clinical trials with efalizumab, a humanized IgG1 monoclonal antibody
directed against LFA-1. The drug was found to be safe, well tolerated, and efficacious in
treating moderate to severe psoriasis.
More recently, a multicenter trial employing efalizumab in conjunction with prednisone,
sirolimus and cyclosporine maintenance immunosuppression in recipients of kidney allografts
showed an acceptable safety profile when used at a dose of 0.5mg/kg/week and excellent
rejection-free graft survival over the first 6 months after transplant.
This study represents the first clinical trial that applies adhesion molecule blockade with
efalizumab to prevent the immune response against pancreatic islets in the setting of type 1
diabetes mellitus, with the long-term goal of immunosuppression withdrawal.
Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market
in April of 2009. Previously transplanted subjects have been transitioned to alternative
immunosuppressives and no new subjects will be transplanted under this protocol.
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