Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00315588

Run by

Rodolfo Alejandro

People needed

7

Starts

2000-12-01

Expected to finish

2014-05-01

Last updated by the study team

2017-04-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Diabetes Research Institute — Miami, Florida, United States

Full record on ClinicalTrials.gov

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