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Keep this study
Lead
ViaCyte
With
California Institute for Regenerative Medicine (CIRM)
Horizon 2020 - European Commission
Vertex Pharmaceuticals Incorporated
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men and non-pregnant women
Diagnosis of T1DM for a minimum of five (5) years
Hypoglycemia unawareness or significant glycemic lability
Stable diabetic treatment
Willingness to use a continuous glucose meter
Acceptable candidate for implantation
You may not be if
History of islet cell, kidney, and/or pancreas transplant.
Six (6) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
Uncontrolled or untreated thyroid disease or adrenal insufficiency
Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
Non-compliance with current anti-diabetic regimen
Detectable stimulated serum C-peptide during screening period assessment.
Clareo Health | A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
