Status:
COMPLETED
Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
National Institutes of Health (NIH)
Conditions:
Type 1 Diabetes Mellitus
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were transplanted under this p...
Detailed Description
This is a Phase I/II study designed to assess the safety and efficacy of sequential islet allotransplantation for the reestablishment of stable glycemic control in type 1 diabetic recipients. A total ...
Eligibility Criteria
Inclusion
- Primary islet allotransplant
- Patients with type 1 diabetes mellitus under intensive insulin management
- Age 18 or older
- Ability to give written informed consent
Exclusion
- Age less than 18 years.
- BMI \>26 kg/m2.
- Insulin requirement of \> 50 IU per day.
- Positive C-peptide response to intravenous arginine stimulation.
- Untreated proliferative retinopathy.
- Creatinine clearance \< 60 ml/min/1.73 m2 for females and 70 ml/min/1.73 m2 for males.
- Serum creatinine \>1.3 mg/dl for females, \>1.5 mg/dl for males.
- Previous pancreas or islet transplant.
- Presence of history of panel-reactive anti-HLA antibodies \>10%.
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures.
- Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB).
- Negative screen for Epstein-Barr Virus (EBV).
- Invasive aspergillus infection within year prior to study entry.
- History of malignancy.
- Active alcohol or substance abuse
- History of non-adherence to prescribed regimens.
- Psychiatric disorder making the subject not a suitable candidate for transplantation.
- Inability to provide informed consent.
- Baseline Hgb \< 11.7 g/dl in females, or \< 13 g/dl in males; lymphopenia (\<1,000/microL), or leukopenia (\<3,000 total leukocytes/microL), or an absolute CD4+ count \<500/microL., or platelets \<150,000/microL
- History of coagulopathy or medical condition requiring long-term anticoagulant therapy after transplantation or patient with INR \>1.5.
- Severe co-existing cardiac disease.
- Baseline liver function tests outside of normal range or history of significant liver disease.
- Active peptic ulcer disease.
- Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
- Presence of severe allergy requiring acute or chronic treatment, or hypersensitivity to drugs similar to RAD (e.g., macrolides).
- Known hypersensitivity to rabbit proteins.
- Hyperlipidemia (fasting LDL cholesterol \> 130 mg/dl, treated or untreated; and/or fasting triglycerides \> 200 mg/dl).
- Addison's disease.
- Under treatment requiring chronic use of systemic steroids.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00286624
Start Date
March 1 2003
End Date
August 1 2006
Last Update
May 8 2008
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455