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Funded Clinical Studies

NIAID supports a range of clinical studies in transplantation, including those that promote immune tolerance, test new drug therapies or combinations, reduce the need for anti-rejection drugs, and develop new ways of testing for transplant rejection. These studies include tests on human samples (blood, urine, and tissue biopsies) that will increase our knowledge of how the immune system responds to a transplant, and how we can manipulate the immune system to improve the outcome of transplantation.

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Clinical Trials in Organ Transplantation (CTOT)

CTOT is a consortium of transplant centers in the United States and Canada that develops and conducts interventional trials and observational clinical studies in organ transplantation, along with coordinated laboratory studies that are designed to show how the treatment altered the immune system response or to explain the clinical observations. The goals of this program are to enhance understanding of the role of the immune system in organ transplantation and rejection, and to apply that understanding to improving transplant success.

Learn more by visiting the CTOT website.

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Clinical Trials in Organ Transplantation in Children (CTOTC)

The CTOTC program focuses on the specific challenges associated with all of pediatric organ transplantation. This program is a continuation of NIAID's first pediatric transplantation clinical trial consortium, the Cooperative Clinical Trials in Pediatric Transplantation program, which studied pediatric kidney transplantation. Currently the consortium is conducting multicenter clinical studies in kidney, heart and lung transplantation at sites in the United States and Canada to

  • Examine how ┬áinfections affect the immune system's response to a transplanted organ in children
  • Test new treatment methods for the prevention of transplant rejection in high risk infants and children
  • Test the safety of reducing the dose or number of anti-rejection drugs that children must take after a transplant
  • Understand why some children and teenagers stop taking their anti-rejection drugs

Support for CTOTC also is provided by the National Heart, Lung, and Blood Institute (NHLBI).
Learn more by visiting the CTOTC website.

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Clinical Islet Transplantation Consortium (CITC)

The purpose of this consortium is to study the production and transplantation of pancreatic islets, the insulin-producing cells of the pancreas, for the treatment of type 1 diabetes. CITC is a network of clinical centers in the United States, Canada, and Scandinavia that are conducting eight clinical trials in pancreatic islet transplantation. CITC centers share clinical and islet manufacturing protocols, data, and results with each other, as well as the broader scientific community.

Two of the studies conducted by this consortium are designed to serve as the basis for a Biologic License Application for Human Pancreatic Islets.

This program is co-sponsored with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and is funded by the Special Statutory Funding Program for Type I Diabetes Research.

Learn more by visiting the CITC website.

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Hematopoietic Stem Cell Transplantation for Treatment of Autoimmune Diseases

NIAID supports two trials to evaluate stem cell transplantation as a treatment for multiple sclerosis, an autoimmune disease that affects the brain and spinal cord, and scleroderma, an autoimmune disease that involves the hardening of the skin and connective tissues of the body. These complex trials, which began in 2006, also include studies to understand the underlying mechanisms of these diseases and treatments.

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Immune Tolerance Network (ITN)

The ITN is an international consortium of over 80 investigators in the United States, Canada, Europe, and Australia dedicated to the clinical evaluation of novel, tolerance-inducing therapies in autoimmune diseases, asthma and allergic diseases, and transplantation. The goal of these therapies is to "reeducate" the immune system to eliminate injurious immune responses, including transplant rejection and graft-versus-host disease, while preserving protective immunity against infection. To understand the underlying mechanisms of action of the candidate therapies and to monitor tolerance, the ITN has established state-of-the art core laboratory facilities to conduct integrated mechanistic studies and to develop and evaluate markers and assays to measure the induction, maintenance, and loss of tolerance in humans.

Current ITN transplantation research focuses on tolerance induction strategies after liver or kidney transplantation, and autologous stem cell transplantation for treating autoimmune disease.

ITN investigators also are developing a centralized ITN Registry of Tolerant Kidney Transplant Recipients. By identifying people who do not reject their transplant even though they are no longer taking immunosuppressive medications, investigators aim to discover what, if any, biological markers define natural tolerance.

The ITN is supported by NIAID, NIDDK, and the Juvenile Diabetes Research Foundation International.

Learn more about the Immune Tolerance Network.

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Renal and Lung Living Donors Evaluation Study (RELIVE)

The purpose of the RELIVE study is to survey and report on the outcome of those who chose to donate a kidney or lobe of a lung as a living organ donor. Established by NIAID in 2006, with additional support from NHLBI and Health Resources and Services Administration (HRSA), RELIVE is no longer enrolling participants, but will be collecting data until 2012. As results become available, they will be shared with the public. Visit the RELIVE Study Results Web site for updates.

Study goals include understanding the health risks of donating a kidney or lobe of a lung; evaluating donors' quality of life after organ donation; and using the study observations to educate potential organ donors.

Learn more by visiting the RELIVE website.

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Solid OrganTransplantation in HIV (HIV-TR)

NIAID funded a multicenter, prospective cohort study to evaluate the safety and effectiveness of kidney or liver transplantation in people with well-controlled HIV infection. These individuals were followed for 5 years after transplant to determine the impact of immunosuppression, HIV infection, and highly active antiretroviral therapy (HAART) on recipient and transplant survival.

Learn more by visiting the HIV-TR website.

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Last Updated March 06, 2009