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

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes

Intervention: Belatacept (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Peter G Stock, M.D., Ph.D., Principal Investigator, Affiliation: University of California, San Francisco
Andrew Posselt, M.D., Ph.D., Principal Investigator, Affiliation: University of California, San Francisco


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.

Clinical Details

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: lnsulin independence


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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

Locations and Contacts

University of California, San Francisco, San Francisco, California 94143, United States
Additional Information

Starting date: February 2004
Last updated: December 4, 2014

Page last updated: August 23, 2015

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