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

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ClinicalTrials.gov Identifier: NCT00315588
Recruitment Status : Completed
First Posted : April 18, 2006
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Islet Transplantation Phase 2

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 hypoglycemic coma and unawareness by islet cell transplantation;
  3. To assess long-term function of successful islet cell transplants;
  4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells.
  5. To assess the effect of exenatide to improve islet graft function and survival in subjects that demonstrate partial graft loss and have returned to using exogenous insulin.
  6. To assess the ability of exenatide to improve islet survival at time of islet transplantation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation
Study Start Date : December 2000
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Islet Transplantation
Islet Transplantation in subjects with a previous kidney transplant.
Drug: Islet Transplantation
Islet Transplantation in subjects with a previous kidney transplant.
Other Name: islet

Outcome Measures

Primary Outcome Measures :
  1. Insulin Independence. [ Time Frame: 1 year ]
    Number of Participants who Achieved Insulin Independence at 1 Year

Secondary Outcome Measures :
  1. Stimulated C-peptide Greater Than 0.5 ng/ml [ Time Frame: 1 year ]
    Partial graft function, as evidenced by basal C-peptide greater than 0.5 ng/ml

  2. Reduction of Insulin Requirements [ Time Frame: 1year ]
    Reduction in insulin requirements in those patients who do not achieve insulin independence

  3. Reduction in Severe Hypoglycemia, Improvement in Hypoglycemia Awareness [ Time Frame: 1 years ]
    Elimination or reduction in the incidence of hypoglycemic coma or unawareness

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients between 18 and 60 years of age.
  2. Patients with type 1 diabetes mellitus.
  3. Patients with a renal transplant that is more than 6 months old.
  4. 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.
  5. 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.
  6. Patients with a body mass index (BMI) of less than or equal to 26.

Exclusion Criteria:

  1. Stimulated or basal C-peptide > 0.3 ng/ml.
  2. Patients with unstable renal function - serum creatinine greater than 0.5 mg/dl above baseline.
  3. 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.
  4. Patients with corrected creatinine clearance of less than 40.
  5. Patients weighing more than 80 kg.
  6. Patients with a body mass index (BMI) of greater than 26.
  7. Insulin requirement > 1.0 U/kg/d.
  8. Anemia (hemoglobin: males < 11.0 g/dl; females < 10.0 g/dl).
  9. Abnormal liver function tests (consistently > 1.5 x normal range).
  10. Unstable diabetic retinopathy.
  11. 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).
  12. 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.
  13. Patients with elevation of prostate-specific antigen > 4 unless malignancy has been excluded.
  14. Patients with unstable cardiovascular status.
  15. 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).
  16. 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).
  17. 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).
  18. Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided).
  19. Patients with active peptic ulcer disease, gallstones, hepatic hemangioma, or portal hypertension.
  20. Patients who are pregnant or breastfeeding, or who intend to procreate.
  21. 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).
  22. Active alcohol or substance abuse; smoking in the last 6 months.
  23. Patients with evidence of sensitization, i.e. panel reactive antibody (PRA) testing greater than 20%.
  24. 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.
  25. Patients with psychogenic factors, which are judged at psychological evaluation, which make it unsafe to undergo islet transplantation, or which preclude therapeutic compliance.
  26. Patients with any condition or any circumstance that would make it unsafe to undergo an islet transplant.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315588

United States, Florida
Diabetes Research Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
Rodolfo Alejandro
National Institutes of Health (NIH)
Health Resources and Services Administration (HRSA)
Diabetes Research Institute Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Rodolfo Alejandro, M.D. University of Miami
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rodolfo Alejandro, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT00315588     History of Changes
Other Study ID Numbers: 2000/0329
5R01DK055347 ( U.S. NIH Grant/Contract )
5R01DK025802 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2006    Key Record Dates
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rodolfo Alejandro, University of Miami:
Islet Transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases