Back to resultsA Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
VC-02 Combination Product (aka PEC-Direct)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-group
Arm Description
Up to six (6) VC-02-20 implants
Outcomes
Primary Outcome Measures
Incidence of all adverse events reported for subjects
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03162926
Brief Title
A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Official Title
An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
February 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViaCyte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-group
Arm Type
Experimental
Arm Description
Up to six (6) VC-02-20 implants
Intervention Type
Combination Product
Intervention Name(s)
VC-02 Combination Product (aka PEC-Direct)
Intervention Description
PEC-01 cells loaded into a Delivery Device
Primary Outcome Measure Information:
Title
Incidence of all adverse events reported for subjects
Time Frame
Thru the Month 4 Visit]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
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