Status:
COMPLETED
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Roche Pharma AG
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte ...
Detailed Description
To assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique, attenuation of postt...
Eligibility Criteria
Inclusion
- Primary islet allotransplant
- Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team:
- Metabolic lability/instability;
- Reduced awareness of 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.
- Age 18 and older
- Able to give written informed consent
Exclusion
- Known hypersensitivity to rabbit proteins.
- Presence of history of panel-reactive anti-HLA antibodies (\>10%).
- Insufficient cardiovascular reserve.
- Creatinine clearance \<60 mL/min/m2.
- Portal hypertension, abnormal liver enzyme tests, or history of significant liver disease.
- History of malignancy within 5 years.
- Active peptic ulcer disease.
- Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
- Pregnancy or breast-feeding.
- Active infections.
- Serological evidence of infection with HIV, or HBsAg or HCVAb positive within the previous 12 months prior to transplantation.
- Negative screen for Epstein-Barr Virus (EBV) by an EBNA method
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening.
- Schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications.
- Ongoing substance abuse; drug or alcohol.
- Recent history of noncompliance.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00285233
Start Date
September 1 2000
End Date
March 1 2005
Last Update
August 2 2012
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455