Status:
ACTIVE_NOT_RECRUITING
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
Lead Sponsor:
CellTrans Inc.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparat...
Detailed Description
This study is a Phase 3 single center, uncontrolled trial in which 1-3 allogeneic pancreatic islet transplants are performed for each study subject. Follow-up evaluations after transplant continue for...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts:
- At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level \<50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
- Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of \<54 mg/dL (3 mmol/l) as reported by the subject
Exclusion
- Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months)
- Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication
- History of non-adherence to prescribed regimens
- Active infection including hepatitis C, hepatitis B, HIV
- TB by history, current infection, or under treatment for suspected TB
- History of malignancies except squamous or basal skin cancer
- Family history of MEN2 or MCT
- Stroke within the past 6 months
- BMI \>27 kg/m2
- C-peptide response to glucagon stimulation, any C-peptide \>0.3 ng/mL
- Inability to provide informed consent
- Age less than 18 or greater than 75 years
- Creatinine clearance \<80 mL/min/1.73 m2 by 24-hour urine collection
- Serum creatinine consistently \>1.5 mg/dL
- Macroalbuminuria \>300 mg/24h
- Baseline Hb \<12 gm/dL in women, \<13 gm/dL in men
- Baseline liver function tests outside normal range
- Untreated proliferative retinopathy
- Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast feeding
- Previous transplant or PRA reactivity \>80%
- Insulin requirement \>0.7 IU/kg/day
- HbA1c \>12%
- Hyperlipidemia (fasting cholesterol \>130 mg/dL or fasting triglycerides \>200 mg/dL
- Medical condition requiring chronic use of steroids
- Use of Coumadin or other antiplatelet or anticoagulant therapy, or PT-INR \>1.5
- Factor V deficiency
- Smoking tobacco
- Addison's disease
- Allergy to radiographic contrast material
- Symptomatic cholecystolithiasis
- Acute or chronic pancreatitis
- Symptomatic peptic ulcer disease
- Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with medication absorption
- Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment
- Use of any study medication within 4 weeks of enrollment
- Received live attenuated vaccine(s) within 2 months of enrollment
- Any medical condition that, in the opinion of the investigator, might interfere with safe participation
Key Trial Info
Start Date :
September 5 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00679042
Start Date
September 5 2007
End Date
June 14 2026
Last Update
October 22 2024
Active Locations (1)
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1
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States, 60612