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About
The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.
Enrollment
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Inclusion criteria
Patients must have type I diabetes mellitus, documented by undetectable C-peptide. Patients must have been diabetic for at least five years, and be aged 18 - 58 years.
Patients must be on an intensive regimen of glucose monitoring and exogenous insulin injection (defined as greater than or equal to three checks and injections per day). This regimen must be prescribed and supervised by the patient's diabetologist.
Despite intensive therapy, patients must have at least one of the following:
Patients must be able to give informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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