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Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501709
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : May 6, 2020
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Pancreatic islets are the part of the pancreas that produce insulin and help control the blood sugar. This study aims to improve islet transplantation as a treatment for Type 1 Diabetes by using a new combination of immunosuppressive drugs that have been successful in treating other autoimmune diseases and in preventing kidney transplant rejection.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Belatacept and Raptiva Phase 1 Phase 2

Detailed Description:
The primary objective of these studies is to assess the efficacy and safety of allogeneic pancreatic islet transplantation in the treatment of type I diabetes mellitus. A secondary study objective is to evaluate the efficacy of various immunosuppressive protocols and agents in preventing autoimmune destruction and rejection of allogeneic islet transplants. A tertiary objective is to determine the safety and efficacy of allogeneic pancreatic islet transplantation in patients who have received another organ transplant such as a kidney or liver.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus
Actual Study Start Date : February 2007
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Belatacept

Arm Intervention/treatment
Experimental: Treatment
Allogenic pancreatic islet transplant using belatacept and raptiva
Drug: Belatacept and Raptiva
immunosuppressant agent to prevent rejection in transplant recipients
Other Name: immunosuppressant

Primary Outcome Measures :
  1. lnsulin independence [ Time Frame: monthly ]
    improved glycemic control

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 Diabetes
  • Metabolic lability/instability characterized by hypoglycemia or ketoacidosis(>2 hospital admissions in the previous year), erratic glucose profiles(MAGE >120mg/dL), or disruption in lifestyle(danger to life, self or others). Reduced awareness of hypoglycemia or > 1 episode in the last 1.5 years of severe hypoglycemia.
  • Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with diabetes care team.
  • Progressive secondary complications as defined by

    • a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or
    • urinary albumin excretion rate >300mg/day but proteinuria <3g/day; or
    • symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)

Exclusion Criteria:

  • Patient weighs more than 80kg or body mass index BMI>28
  • Patient's insulin requirement is >55 Units/day.
  • Current use of immunosuppressive agents.
  • History of malignancy within 10 years (except for adequately treated basal or squamous cell CA of the skin).
  • Active peptic ulcer disease.
  • Severe unremitting diarrhea or other GI disorders potentially interfering with the ability to absorb oral medications.
  • Untreated proliferative retinopathy.
  • Pregnancy or breastfeeding.
  • Female subjects not post-menopausal or surgically sterile, or not using an acceptable method or contraception.
  • Active infections.
  • Major ongoing psychiatric illness.
  • Ongoing substance abuse, drug or alcohol; or recent history of noncompliance.
  • Portal hypertension or history of significant liver disease.
  • Lymphopenia (<1000/ul) or leukopenia (<3000 total leukocytes/ul) or an absolute CD4 count <500/ul.
  • Presence or history of panel-reactive anti-HLA antibody >20%.
  • Evidence of acute EBV infection (IgM>IgG) OR no serologic evidence of previous exposure to EBV (IgG>IgM).
  • Serologic evidence of infection with HIV or HbsAg or HCV Ab positive.
  • Creatinine clearance <60ml/min/m2.
  • Positive lymphocytoxic cross-match using donor lymphocytes and serum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501709

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Juvenile Diabetes Research Foundation
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Principal Investigator: Peter G Stock, M.D., Ph.D. University of California, San Francisco
Principal Investigator: Andrew Posselt, M.D., Ph.D. University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT00501709    
Other Study ID Numbers: 39-42C
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents