The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant. The primary objectives of the study are: \- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works The Secondary objective of the study is: * To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab. All patients will receive Etanercept to promote engraftment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Islet after kidney transplant in patients with type I diabetes.
Given as induction for islet cell transplant
Massachusetts General Hospital
Boston, Massachusetts, United States
Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.
Time frame: 1 year after the subject's first islet transplant
Number of Participants With a Decrease in HbA1c
Subjects will have a decrease in HbA1c of at least \>1%
Time frame: 1 year after subject's first islet transplant
Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine
Proteinuria and serum creatinine will be stable or decreased as compared to pre-transplant values
Time frame: 1 year after subjects initial islet transplant
An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction
Time frame: 1 year after the subject's first islet transplant
Impact on Vision
Improvement of frequency of interventions and from changes in reported visual acuity with optical refraction and severity of diabetic retinopathy
Time frame: 1 year after the subject's first islet transplant
Absence of Negative Renal Impact Measures
Loss of allograft survivial (return to dialysis, retransplant, death) and Renal allograft function meausred by SCr
Time frame: 1 year after the subject's first islet transplant
Improvement of Metabolic Control
Whether there is an improvement in metabolic control in IAK will be evaluated based on improvement in 1. basal c-peptide levels, 2. MMTT, 3. insulin requirements, and 4. c-peptide to glucose, creatinine ratio (CPGCR).
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Time frame: 1 year after the subject's first islet transplant
Number of Participants With a Decrease of Severe Hypoglycemic Events
Subjects will have a decrease in severe hypoglycemic events
Time frame: 1 year after subject's first transplant
Reduction of Insulin Requriements
Evidence of partial success will be considered for subjects who have a reduction in insulin requirements but who are not insulin independent. This will be assessed by comparing the pre-transplant insulin requirement expressed as insulin units per kg per day with the requirement preceding subsequent islet transplants and the insulin requirements at 6 months and 1, 2, and 3 years after the first and last transplant.
Time frame: 1 year after the subject's first islet transplant