A Safety and Tolerability Study of VC-02™ Combination Pro... | NCT03162926

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

NCT03162926

Sponsor

ViaCyte

Status

Completed

Last Update Posted

Oct 18, 2018Actual

Enrollment

3Actual

Phase

Phase 1

Conditions

Type 1 Diabetes Mellitus

Interventions

VC-02 Combination Product (aka PEC-Direct)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2017Actual

Primary Completion Date

Feb 15, 2018Actual

Completion Date

Feb 15, 2018Actual

First Submitted Date

May 19, 2017

First Submission Date that Met QC Criteria

May 19, 2017

First Posted Date

May 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2018

Last Update Posted Date

Oct 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single-group	Experimental	Up to six (6) VC-02-20 implants	Combination Product: VC-02 Combination Product (aka PEC-Direct)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VC-02 Combination Product (aka PEC-Direct)	Combination Product	PEC-01 cells loaded into a Delivery Device	Single-group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of all adverse events reported for subjects		Thru the Month 4 Visit]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta		Canada

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided