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Clinical Trials

Building on clinical trial and laboratory research insights from the past decade, the ITN has focused and deliberate strategies to achieving tolerance in each disease area. The research supported by the ITN has unlocked new therapeutic approaches and discovered new biomarkers that promise to change the way physicians treat patients. Explore ITN clinical trials below by using a search term or by sorting the specific trial categories. If you have questions or want more information about ITN clinical trials, contact us.

Completed

Monitoring of CMV-specific T-cells following tolerance induction protocols: A safety approach

Principal Investigator:
Florian Kern, Institut für Medizinische Immunologie, Berlin, Germany
This study seeks to optimize and standardize an existing assay which allows the T-cell response directed against in transplant recipients who undergo immune tolerance induction. This study employs a rapid laboratory test that would enable the transplant physicians to look at the patient's immune response to this model virus.
Learn more: Study Summary

Follow-up of individual T cell mobilization through TCR integration

Principal Investigator:
Jean Paul Soullilou, Institute de Transplantation, Nantes, France
This trial investigates the landscape of blood T lymphocytes in patients with active forms of multiple sclerosis. The goal of the study is to demonstrate T cell receptor (TCR) patterns that are specific for disease activity at the patient level and then to use this “TCR signature” to follow regulation of auto reactive T cells, particularly during tolerance induction.
Learn more: Study Summary

Proleukin® and Rapamune® in Type 1 Diabetes Mellitus (IL2-RAPA)

Principal Investigator:
Carla Greenbaum, Benaroya Research Institute, Seattle, WA
This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes.
Learn more: Study Summary Clinicaltrials.gov

Treatment of Psoriatic Arthritis with hOKT3γ(Ala-Ala): Psoriatic Arthritis Research Trial (PART)

Principal Investigator:
Marcus Clark, University of Chicago, Chicago, IL
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.
Learn more: Study Summary Clinicaltrials.gov

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE)

Principal Investigator:
John H. Stone, Johns Hopkins University, Baltimore, MD
Ulrich Specks, Mayo Clinic, Rochester, MN
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating adults with WG and MPA.
Learn more: Study Summary Clinicaltrials.gov

Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis (STAYCIS)

Principal Investigator:
Scott Zamvil, University of California, San Francisco, CA
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients.
Learn more: Study Summary Clinicaltrials.gov

A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

Principal Investigator:
Samia Khoury, Brigham & Women's Hospital, Boston, MA
Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS.
Learn more: Study Summary Clinicaltrials.gov

Study of Antithymocyte Globulin for Treatment of New-onset T1DM (START)

Principal Investigator:
Stephen Gitelman, University of California, San Francisco, CA
Thymoglobulin is an antibody preparation that is commonly used to treat and prevent organ transplant rejection. The START trial aims to determine whether Thymoglobulin treatment can halt the progression of newly diagnosed type 1 diabetes when given within 3 months of diagnosis. This study is for people aged 12-35 years old.
Learn more: Study Summary Clinicaltrials.gov Study Website

Autoantigen Vaccination in Human Type 1 Newly Diagnosed Diabetes Mellitus

Principal Investigator:
Tihamer Orban, Joslin Diabetes Center, Boston, MA
In addition to regulating blood sugar, insulin may have the ability to protect cells in the pancreas from attack by the immune system. This study will evaluate whether an insulin-based vaccine can protect cells from autoimmune destruction.
Learn more: Study Summary Clinicaltrials.gov

Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE)

Principal Investigator:
Kevan Herold, Yale University, New Haven, CT
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) can halt the progression of type 1 diabetes in patients diagnosed within the past 60 days.
Learn more: Study Summary Clinicaltrials.gov

Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients (WISP-R)

Principal Investigator:
Sandy Feng, University of California San Francisco, San Francisco, CA
Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.
Learn more: Study Summary Clinicaltrials.gov

Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (A-WISH)

Principal Investigator:
Abraham Shaked, University of Pennsylvania, Philidelphia, PA
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes and cancer. This study is investigating whether liver transplant recipients can slowly be taken off these drugs under medical supervision.
Learn more: Study Summary Clinicaltrials.gov

Immune System Suppression with Alemtuzumab and Tacrolimus in Liver Transplantation Patients (TILT)

Principal Investigator:
J. Richard Thistlethwaite, University of Chicago, Chicago, IL
This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.
Learn more: Study Summary Clinicaltrials.gov

Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance

Principal Investigator:
George W. Burke, University of Miami, Miami, FL
Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.
Learn more: Study Summary Clinicaltrials.gov

Belatacept to Prevent Organ Rejection in Kidney Transplant Patients

Principal Investigator:
Flavio Vincenti, University of California, San Francisco, CA
Christian Larsen, MD, Emory University, Atlanta, GA
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had kidney transplants. This study will determine whether a combination of anti-rejection drugs, including belatacept, can prevent the rejection of a first-time, non-HLA identical kidney transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant.
Learn more: Study Summary Clinicaltrials.gov

Campath-1H/Tacrolimus/Sirolimus Withdrawal in Renal Transplantation

Principal Investigator:
Stuart Knechtle, University of Wisconsin, Madison, WI
The purpose of this study is to test the safety and effectiveness of using alemtuzumab in combination with two other drugs, sirolimus and tacrolimus, to prevent organ rejection after kidney transplantation. This study will also test whether this combination of medications will allow patients to eventually stop taking antirejection medications entirely.
Learn more: Study Summary Clinicaltrials.gov

Mixed Chimerism and Renal Allograft with Non-Myeloablative Conditioning in Patients with ESRD Due to Multiple Myeloma

Principal Investigator:
Megan Sykes, Massachusetts General Hospital, Boston, MA
The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.
Learn more: Study Summary Clinicaltrials.gov

Mixed Chimerism I: Renal Allograft Tolerance Through Mixed Chimerism

Principal Investigator:
David H. Sachs, Massachusetts General Hospital, Boston, MA
A. Benedict Cosimi, Massachusetts General Hospital, Boston, MA
This study examines the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant recipient. An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the body's immune system.
Learn more: Study Summary Clinicaltrials.gov

Multicenter Trial of Islet Transplantation in Type 1 Diabetic Patients Using the Edmonton Protocol

Principal Investigator:
James Shapiro, University of Alberta, Edmonton, Alberta, Canada
This was a multicenter clinical trial of the Edmonton protocol for islet transplantation.
Learn more: Study Summary

Promoting Tolerance to Peanut in High-Risk Children (LEAP)

Principal Investigator:
Gideon Lack, Evelina Children's Hospital, London, United Kingdom
Infants who suffer from eczema or egg allergy have a 1 in 5 chance of developing peanut allergy by age 5. This study is evaluating whether consuming or avoiding peanut early in life can reduce the risk of peanut allergy in these high risk children.
Learn more: Study Summary Clinicaltrials.gov Study Website

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