Status:
WITHDRAWN
Clinical Islet Transplantation Using the Edmonton Protocol
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
London Health Sciences Centre
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of this study is to perform a series of islet transplants using the Edmonton protocol. Patients with Type I Diabetes and glycemic lability, severe hypoglycemia or hypoglycemic unawareness ...
Detailed Description
The purpose of this study is to document the outcomes of islet transplant at our centre while replicating the Edmonton protocol. The Edmonton protocol, as described above, is currently the standard cl...
Eligibility Criteria
Inclusion
- age 18-65 years
- type 1 diabetes for at least 5 years
- at least 1 of the following: a) frequent, severe hypoglycaemia b) hypoglycemic unawareness\* c) glycemic lability despite an optimal insulin regimen\*, and failure of intensive insulin therapy as judged by independent endocrinologist
Exclusion
- obesity (BMI \>28
- insulin requirements \> 0.7 U/kg/day
- history of cancer (except basal or squamous skin cancer)
- unstable, severe, or non-correctable cardiac disease
- previous organ transplant
- evidence of sensitization (PRA\>20%)
- renal dysfunction (macroalbuminuria, renal dialysis)
- untreated proliferative retinopathy
- active infection, including hep C, hep B, HIV, TB
- current cigarette smoking (6 months abstinence required) or substance abuse
- indication for steroid medications (exception steroid inhalers, topical steroids)
- indication for anticoagulation (exception aspirin)
- pregnancy or desire for future pregnancy; breast-feeding
- major psychiatric illness
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00309231
End Date
January 1 2008
Last Update
March 15 2017
Active Locations (1)
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1
London Health Sciences Centre University Campus
London, Ontario, Canada, N6A 4L6