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NCT03162926 Clinical Trial

A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:
An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03162926
Other study ID # VC02-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 5, 2017
Est. completion date February 15, 2018

Study information
Verified date October 2018
Source ViaCyte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date February 15, 2018
Est. primary completion date February 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device

Locations
Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)
Lead Sponsor Collaborator
ViaCyte

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of all adverse events reported for subjects Thru the Month 4 Visit]
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