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The Immune Tolerance Network's (ITN's) START research trial for new-onset type 1 diabetes has received the approval of its Data Safety and Monitoring Board to accept patients aged 12-18 years into the study. The decision was made after a review of safety data from the initial group of 10 adult subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with new-onset type 1 diabetes within the past 3 months. The START trial is being conducted under the direction of principal investigator Dr. Stephen Gitelman at the University of California, San Francisco and at 9 other research centers in the US

Results of the Immune Tolerance Network's (ITN's) study of a novel vaccine for treatment of new onset type 1 diabetes has been published in the Journal of Autoimmunity. Led by Joslin Diabetes Clinic's Tihamer Orban, the study determined that a vaccine comprised of insulin B-chain in incomplete Freund's adjuvant was generally safe and well-tolerated. Importantly, for up to two years following treatment, in peripheral blood from subjects receiving this vaccine, insulin-B-chain-specific CD4+ T cells could be detected, that showed phenotypic and functional characteristics of regulatory cells.

The Immune Tolerance Network (ITN) is seeking ‘Proposal Outlines’ for novel clinical trials designed to induce immune tolerance in psoriasis and other autoimmune skin disorders, including those mediated by autoantibodies such as pemphigus and pemphigoid.

Three abstracts from Immune Tolerance Network (ITN) studies are being presented at this year's American Transplant Congress in Boston, MA, held May 20-June 3, 2009.

The full cohort of 640 children has now been enrolled in the Immune Tolerance Network (ITN) LEAP study of peanut allergy. The study is being conducted under the direction of principal investigator Gideon Lack, MD at Evelina Children’s Hospital, part of Guys and St Thomas Hospital in London, UK. The study addresses a growing scientific and public health controversy as to whether children at risk of developing peanut allergy can best prevent the condition by regular consumption of peanut or by avoiding it altogether. Results of the long-term study are expected in 2013.

The Immune Tolerance Network (ITN) has completed enrolling the full cohort of 83 patients in its Autoimmunity-blocking Antibody for Tolerance in type 1 diabetes, or ‘AbATE’ trial.

The ITN protocol for the measurement of Fox-P3-expressing T regulatory (Treg) cells has been published in the March 2009 issue of the peer-reviewed journal Cytometry B: Clinical Cytometry.

Summary - The purpose of this EOI is to gather information from the scientific community about novel ideas for tolerogenic immunotherapeutic trials in type 1 diabetes (T1D) under the ITN-JDRF Partnership in Type 1 Diabetes Program. Expressions of interest should be submitted no later than April 13, 2009.

Doctors at Massachusetts General Hospital have enrolled the first of 15 planned patients in the ITN's expanded clinical trial of mixed chimerism, a technique designed to replace the need for long-term immunosuppression in kidney transplantation. The patient, who suffered from end-stage renal failure caused by Alport's Syndrome, received bone marrow and a kidney from the same living donor on January 27, 2009. Both donor and recipient are currently doing well. The current study is an expanded, follow-up study to a previous ITN-sponsored trial where 4 of 5 subjects were able to stop immunosuppression for up to 5 years, as reported in the New England Journal of Medicine in January 2008.

The Feinstein Institute in New York City has enrolled the first patient in the Immune Tolerance Network’s ACCESS clinical trial of abatacept and cyclophosphamide for lupus nephritis. The study is seeking to enroll 100 participants at clinical centers across the US and Mexico over the next three years.