Status:
ACTIVE_NOT_RECRUITING
A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Lead Sponsor:
Northwestern University
Conditions:
Type 1 Diabetes
Severe Hypoglycemic Unawareness
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Detailed Description
(T1D) Type 1 diabetes afflicts nearly 2 million people in the United States, most of them children or young adults. Untreated, it is a fatal disease. Exogenous insulin, administered by multiple inject...
Eligibility Criteria
Inclusion
- 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
- Or, previous islet cell transplant recipients who have returned to partial or full insulin usage and are taking maintenance immunosuppression medications.
- 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
- Macroalbuminuria \>300 mg/g creatinine
- 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)
- Negative Epstein-Barr Virus (EBV) by IgG
- Any history of malignancy except resected squamous or basal cell carcinoma
- Alcohol or substance abuse
- Baseline Hb below the lower limit of normal
- International normalized ratio \>1.5 and long term anticoagulant therapy
- Clinically significant coronary artery disease
- Elevated liver function tests \>1.5 times upper limit of normal
- Symptomatic cholecystolithiasis
- Gastrointestinal disorders interfering with ability to absorb oral medications
- Uncontrolled hyperlipidemia (LDL cholesterol \>130 mg/dL and/or triglycerides \>200 mg/dL)
- Chronic corticosteroid use
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01897688
Start Date
June 1 2012
End Date
March 1 2027
Last Update
March 19 2024
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611