A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients (NCT01897688) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
United States40 participantsStarted 2012-06
Plain-language summary
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female patients age 18-65 years of age at consent
✓. Ability to provide written informed consent
✓. Mentally stable and able to comply with the procedures of the study protocol
✓. Patients with T1D and insulin-dependent for at least 5 years fulfilling the following criteria:
✓. Absent stimulated c-peptide (\<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption
✓. Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
✓. At least one episode of severe hypoglycemia in the past 12 months
✓. A Clarke score of 4 or more defining reduced awareness of hypoglycemia
Exclusion criteria
✕. Body mass index (BMI) \> 30
✕. Insulin requirement of \> 1.0 IU/kg/day
✕. HbA1c \> 10%
✕. Calculated glomerular filtration rate (GFR) \< 80mL/min for transplant-naïve patients (using subjects serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration equation CKD-EPI) or 50mL/min for previously transplanted patients currently on immunosuppression
What they're measuring
1
To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes.
Timeframe: Two years after the final islet transplant.
✕. Panel reactive anti-HLA antibodies\> 50% by flow cytometry
✕. For female subjects: positive pregnancy test, breast feeding or unwillingness to use effective contraceptive measures for the duration of the study.
✕. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB)