Status:
COMPLETED
Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression
Lead Sponsor:
Rodolfo Alejandro
Collaborating Sponsors:
National Institutes of Health (NIH)
Health Resources and Services Administration (HRSA)
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
SPECIFIC AIMS: 1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation; 2. To eliminate the incidence of hypoglycemia coma and unawa...
Detailed Description
This Phase II trial will have 3 groups: Group A will receive islets from 2 donors and will not receive infliximab. Group B will receive, in addition to Daclizumab, Sirolimus, and Tacrolimus, a dose of...
Eligibility Criteria
Inclusion
- Patients between 18 and 65 years of age
- Patients with type 1 diabetes mellitus for more than 5 years duration
- One or more of the following:
- Hypoglycemia unawareness - judged by history of blood sugars \<54 on glucometer without symptoms and/or hypoglycemic episodes requiring assistance from either family, glucagon administration or emergency services
- Poor diabetes control (HbA1c\>8% or \>2 visits/yr to hospital for treatment of ketoacidosis) despite intensive insulin therapy
- Progressive complications of type 1 diabetes mellitus
- Body Mass Index (BMI) ≤26
Exclusion
- c-peptide \> 0.3ng/ml basal or stimulated;
- untreated proliferative diabetic retinopathy;
- HbA1C \>12%;
- creatinine clearance \<60;
- serum creatinine consistently \>1.6 mg/dl;
- macroalbuminuria \>300mg albumin in 24 hours;
- presence of panel reactive antibodies (PRA) \>20%;
- previous/concurrent organ transplantation (except previous unsuccessful islet cell transplant;
- malignancy or previous malignancy (except non-melanomatous skin cancer);
- x-ray evidence of pulmonary infection;
- active infections;
- active peptic ulcer disease, gall stones, hemangioma, or portal hypertension
- serological evidence of HIV, HbsAg or HCV; serological evidence of active EBV (IgM\>IgG) or EBV negative serology;
- PPD conversion or positive PPD without historic completion of appropriate prophylactic treatment;
- abnormal liver function test;
- anemia (hemoglobin \<12.0);
- hyperlipidemia (fasting serum triglycerides \>200mg/dl and/or fasting serum cholesterol \>240 mg/dl and/or fasting LDL cholesterol \>140 mg/dl);
- BMI above 26;
- unstable cardiovascular status; prostate specific antigen (PSA) \>4;
- pregnancy or breastfeeding;
- sexually-active females who are not: a) post-menopausal, b) surgically sterile, or c) not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable);
- alcohol abuse, substance abuse or smoking within the previous 6 months; insulin requirement \>1u/kg/day and any condition or any circumstance that makes it unsafe to undergo an islet cell transplant.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2004
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00306098
Start Date
December 1 2000
End Date
July 4 2004
Last Update
November 4 2024
Active Locations (1)
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1
University of Miami, Diabetes Research Institute
Miami, Florida, United States, 33136