UCSF - Immune Tolerance Network
The ITN conducts clinical trials and tolerance assay studies in a number of disease areas:
· Islet Transplantation · Kidney & Liver Transplantation · Autoimmune Diseases · Allergy & Asthma
A New, Innovative Model for Clinical Tolerance Research
The Immune Tolerance Network is not simply a funding agency. In addition to providing subcontracted research funds, the ITN provides a number of key tools to help investigators get the most from their research, whether it is academic or industry-initiated, a clinical trial or an assay for tolerance: Assistance identifying potential collaborators and clinical sites; an in house “CRO-style” Clinical Trials Group for trial planning, development, monitoring and analysis; Access to cutting-edge biological assays and equipment; Scientific and administrative support; Assistance in procuring vital agents & equipment. In addition, ITN investigators have access to the expertise of some of the field’s most prominent figures.
Every clinical trial supported by the Immune Tolerance Network is augmented by a series of mechanistic studies designed to uncover the basic biological features of clinical tolerance. The ITN works with investigators to choose an ideal set of assays that will provide direct feedback for subsequent trial development. The ITN operates a number of Core Facilities providing investigators with cutting-edge technologies designed to increase our understanding of tolerance.
Research supported by the ITN comes from a year-round, open call for proposals from tolerance researchers around the world. Our highly interactive peer-review process ensures all applicants are given thorough and fair consideration. Once funded, the ITN provides an interactive platform for developing ideas into high-impact clinical and tolerance assay research. The ITN’s Clinical Trials Group offers a wealth of scientific, technical and administrative support, including trial development and regulatory assistance, as well as monitoring staff and experts and tools for data analysis. The ITN’s Tolerance Assay Group assists investigators with the development, data acquisition and analysis for mechanistic and marker studies associated with every trial.
Specific Research Areas:
ISLET TRANSPLANTATION - The ITN investigates novel strategies aimed at creating and maintaining long-term tolerance to transplanted islet cells. The goal of the program is the restoration of normal insulin production in Type I diabetes patients, without the need for long-term immunosuppressive therapy. A key issue in this regard is finding ways to alleviate both the alloimmune response and the ongoing autoimmune response in these affected individuals.
SOLID ORGAN TRANSPLANTATION - Clinical trials in liver and renal transplantation are closely related to those performed in islet transplant recipients. In addition, the Network aims to test potential tolerance induction strategies against the backdrop of maintenance immunosuppression that does not include calcineurin inhibitors. Combination drug therapies, including the use of hematopoietic stem cell chimerization, are a key focus of the ITN.
AUTOIMMUNE DISEASES - The ITN conducts clinical trials and mechanistic studies aimed at alleviating the autoimmune responses which characterize these diseases. The main disease entities studied include: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Multiple Sclerosis, and Type I diabetes, however the ITN is keenly interested in clinical studies of other diseases.
ALLERGY/ASTHMA – Studies in allergy and asthma aim to ameliorate allergen-specific Th2-driven processes and replace these processes with allergen-specific, protective immune responses. Among the diseases falling under the research mandate of the Asthma and Allergic Diseases Subgroup are allergic rhinitis (seasonal and perennial), and allergic asthma.
TOLERANCE ASSAYS & CORE FACILITIES- In each of the disease areas, the Network Tolerance Assay Group (TAG) supports clinical trials by i) examining the mechanism(s) that create and maintain the tolerant state and ii) developing of set of assays that will function as a roadmap to guide clinicians in their attempt to create and monitor immune tolerance in individual patients. The TAG oversees several Core assay facilities and the standardization of assay protocols performed at local clinical centers.