A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
NCT ID: NCT03162926
Last Updated: 2018-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2017-07-05
2018-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single-group
Up to six (6) VC-02-20 implants
VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device
Interventions
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VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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ViaCyte
INDUSTRY
Responsible Party
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Locations
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University of Alberta
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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VC02-102
Identifier Type: -
Identifier Source: org_study_id
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