Type 1 Diabetes Mellitus
Conditions
Brief summary
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.
Interventions
COMBINATION_PRODUCTVC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device
Sponsors
ViaCyte
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and non-pregnant women of non-childbearing potential * Diagnosis of T1DM for a minimum of five (5) years * Stable diabetic treatment * Willingness to use a continuous glucose meter * Acceptable candidate for implantation
Exclusion criteria
* History of islet cell, kidney, and/or pancreas transplant. * Two (2) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of all adverse events reported for subjects | Thru the Month 4 Visit] |
Countries
Canada
Outcome results
None listed