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

NCT ID: NCT00501709

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2016-12-31

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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Allogenic pancreatic islet transplant using belatacept and raptiva

Group Type: EXPERIMENTAL

Belatacept and Raptiva

Intervention Type: DRUG

immunosuppressant agent to prevent rejection in transplant recipients

Interventions

Belatacept and Raptiva

immunosuppressant agent to prevent rejection in transplant recipients

Intervention Type: DRUG

Other Intervention Names

immunosuppressant

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter G Stock, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Andrew Posselt, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

39-42C

Identifier Type: -

Identifier Source: org_study_id