Status:
TERMINATED
Islet Transplantation for Type 1 Diabetes Mellitus
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time, associated with an increased risk of severe...
Eligibility Criteria
Inclusion
- Duration of diabetes: 5 years or more
- Type 1 diabetes with C-peptide \< 200 pmol/L and a simultaneous plasma glucose between 60 and 250 mg/dl
- Complex insulin program supervised by an endocrinologist for at least 6 months
- Hypoglycemic unawareness diagnosed using Clarke Awareness Questionnaire
- Body weight \< 70 kg
- Body Mass Index \< 30 kg/m\^2
- Insulin requirement \< 40 units/day by multiple daily injections or \< 30 units /day by external insulin pump or \< 0.6 unit/kg/day with a HbA1c \< 7.0 % ( Normal \< 6 %)
- No overt cardiovascular disease
- No laser treatment for retinopathy
- Retinopathy diagnosed by ophthalmologist to be stable and requiring no further evaluation for at least one year
- Women of child bearing age will have a negative pregnancy test at screening and time of trial initiation
- Women enrolled in the trial should be willing to practice birth control while on immunosuppression
- No psychologic issues that would interfere with adherence to safe clinical practice
- Blood type (ABO) compatibility
- No evidence of chronic liver disease (aspartate aminotransferase (AST) \< 2.5 times normal, alanine aminotransferase (ALT) \< 2.5 times normal, international normalized ratio (INR) \< 1.4, No evidence of fatty liver on abdominal ultrasound.
Exclusion
- Ongoing infection
- Ongoing alcohol or drug abuse
- Clinical portal hypertension
- Gall stones
- Liver hemangioma on ultrasound interfering with islet infusion
- Lack of updated immunization
- Unstable cardiovascular status as defined by:
- Myocardial infarction/acute coronary syndrome in last year
- Significant coronary atherosclerosis on angiography
- Active ischemia at evaluation
- Pre-trial low-density lipoprotein (LDL) cholesterol \> 100 and triglycerides \> 200 mg/dl with or without lipid lowering therapy
- Active peptic ulcer disease
- Previous organ transplantation except islet transplantation
- Negative serology for Epstein-Barr Virus (EBV) or ongoing acute EBV infection
- Previous malignancy unless
- 5 years ago
- basal cell cancer
- squamous cell cancer
- Requiring steroid therapy for any reason
- Positive Purified Protein Derivative (PPD - Tuberculosis Skin Test)
- Serological evidence of HIV, Hepatitis C or Hepatitis B
- Chronic anemia
- Single Antigen B (SAB) normalized value \>1500
- Renal disease
- Iothalamate clearance \< 70 cc/min
- 24 hour urine protein \> 500 mg/24 hours
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00437398
Start Date
July 1 2006
End Date
January 1 2012
Last Update
April 25 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905