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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

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.

Clinical Details

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

Primary outcome: lnsulin independence

Eligibility

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

Criteria:

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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