Status:
COMPLETED
Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Lead Sponsor:
Rodolfo Alejandro
Collaborating Sponsors:
National Institutes of Health (NIH)
Health Resources and Services Administration (HRSA)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to reverse hyperglycemia and insulin dependency, by islet cell transplantation, in patients with type 1 diabetes mellitus who have a stable kidney allograft.
Detailed Description
1. To reverse hyperglycemia and insulin dependency by islet cell transplantation, in patients with Type 1 Diabetes Mellitus who have a stable kidney allograft; 2. To eliminate the incidence of hypogly...
Eligibility Criteria
Inclusion
- Patients between 18 and 60 years of age.
- Patients with type 1 diabetes mellitus.
- Patients with a renal transplant that is more than 6 months old.
- Patients with stable renal graft function for the preceding 6 months, i.e. no episodes of rejection and changes in serum creatinine no more than 0.5 mg/dl from baseline.
- Patients who are taking tacrolimus, sirolimus +/- steroids for maintenance immunosuppression for at least 6 months and are tolerating levels satisfactory for islet transplantation without severe complications.
- Patients with a body mass index (BMI) of less than or equal to 26.
Exclusion
- Stimulated or basal C-peptide \> 0.3 ng/ml.
- Patients with unstable renal function - serum creatinine greater than 0.5 mg/dl above baseline.
- Patients with proteinuria (albuminuria \> 300 mg in 24 hours +/- protein) of new onset since kidney transplantation. If proteinuria or albuminuria is thought to originate from the native kidney(s) this will not be an exclusion criterion.
- Patients with corrected creatinine clearance of less than 40.
- Patients weighing more than 80 kg.
- Patients with a body mass index (BMI) of greater than 26.
- Insulin requirement \> 1.0 U/kg/d.
- Anemia (hemoglobin: males \< 11.0 g/dl; females \< 10.0 g/dl).
- Abnormal liver function tests (consistently \> 1.5 x normal range).
- Unstable diabetic retinopathy.
- Evidence of acute or chronic active Epstein-Barr virus (EBV) infection (IgM ≥ IgG). Patients will be eligible if serological testing becomes consistent with previous exposure (i.e. IgG \> IgM).
- Patients with history of malignancy or current malignancy other than non-melanomatous skin cancer, or finding of any lesions or symptoms during screening that are suspicious for malignancy, until properly investigated and ruled out.
- Patients with elevation of prostate-specific antigen \> 4 unless malignancy has been excluded.
- Patients with unstable cardiovascular status.
- Patients with active infections until adequately treated, unless treatment is not judged as necessary by the investigators (including, but not limited to, mild skin and nail fungal infections).
- Patients with serological evidence of infection with HIV, human t cell lymphotropic virus 1 (HTLV 1), HTLV 2, or hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable).
- Patients with history and/or serological evidence of hepatitis C (those patients with hepatitis C, already transplanted in this protocol will continue in this trial).
- Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided).
- Patients with active peptic ulcer disease, gallstones, hepatic hemangioma, or portal hypertension.
- Patients who are pregnant or breastfeeding, or who intend to procreate.
- Patients who are sexually active females who are not:
- post-menopausal,
- surgically sterile, or
- using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices combined with spermicidal gel are acceptable; condoms used alone are not acceptable).
- Active alcohol or substance abuse; smoking in the last 6 months.
- Patients with evidence of sensitization, i.e. panel reactive antibody (PRA) testing greater than 20%.
- Lack of updated immunizations per current Centers for Disease Control (CDC) guidelines, as well as immunization against hepatitis B, pneumococcus, and influenza (during season), unless medically contraindicated.
- Patients with psychogenic factors, which are judged at psychological evaluation, which make it unsafe to undergo islet transplantation, or which preclude therapeutic compliance.
- Patients with any condition or any circumstance that would make it unsafe to undergo an islet transplant.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00315588
Start Date
December 1 2000
End Date
May 1 2014
Last Update
April 12 2017
Active Locations (1)
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1
Diabetes Research Institute
Miami, Florida, United States, 33136