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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03162926
Recruitment Status : Active, not recruiting
First Posted : May 22, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
ViaCyte

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Combination Product: VC-02 Combination Product (aka PEC-Direct) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single-group
Up to six (6) VC-02-20 implants
Combination Product: VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device



Primary Outcome Measures :
  1. Incidence of all adverse events reported for subjects [ Time Frame: Thru the Month 4 Visit] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162926


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
ViaCyte

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT03162926     History of Changes
Other Study ID Numbers: VC02-102
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases