Status:
TERMINATED
Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes Mellitus
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of ef...
Detailed Description
The purpose of this study is to improve the applicability of islet transplantation for treatment of type 1 diabetes utilizing a novel immunosuppressive regimen centered on the use of adhesion molecule...
Eligibility Criteria
Inclusion
- Primary islet allotransplant
- Type I diabetes mellitus for a minimum of 5 years
- One of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
- Metabolic lability/instability characterized by hypoglycemia or ketoacidosis (\>2 hospital admissions in the previous year), erratic glucose profiles (MAGE\>120 mg/dL), or disruption in lifestyle of 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 the diabetes care team)
- Progressive secondary complications as defined by (i) a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) urinary albumin excretion rate \>300 mg/day but proteinuria \<3g/day; or (iii) 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)
- Age 18 to 65 years of age.
Exclusion
- Current use of immunosuppressive agents
- Lymphopenia (\<1000/µL) or leukopenia (\<3000 total leukocytes/µL)
- Presence of panel-reactive anti-HLA antibody \>20%
- Positive lymphocytotoxic cross-match using donor lymphocytes and serum
- Evidence of acute EBV infection (IgM\>IgG) OR negative screen for EBV by IgG determination
- Calculated or measured GFR \< 60 ml/min/m2
- Portal hypertension or history of significant liver disease
- 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 of contraception
- Active infections
- Serologic evidence of infection with HIV, or HbsAg or HCV Ab positive
- Major ongoing psychiatric illness
- Ongoing substance abuse, drug or alcohol; or recent history of noncompliance
- Any condition that in the opinion of the Principle Investigator would not allow for safe participation in the study
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00672204
Start Date
November 1 2007
End Date
August 1 2012
Last Update
October 25 2017
Active Locations (1)
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1
Universtiy of Minnesota
Minneapolis, Minnesota, United States, 55455