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

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: NCT03163511
Recruitment Status : Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : July 15, 2022
Sponsor:
Collaborators:
California Institute for Regenerative Medicine (CIRM)
Horizon 2020 - European Commission
Information provided by (Responsible Party):
ViaCyte

Study Description
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Brief Summary:
VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus With Hypoglycemia Combination Product: VC-02 Combination Product Phase 1 Phase 2

Detailed Description:
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: There are two Cohorts in this study design. Cohort 1 enrolls up to 15 subjects total. After Cohort 1 enrollment is completed, Cohort 2 enrollment then occurs with up to an additional 60 subjects.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to two (2) VC-02-300 implants
 Combination Product: VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Other Name: PEC-Direct
Experimental: Cohort 2
VC-02 Combination Product; Up to twelve units implanted of which up to ten (10) are VC-02-300 implants and the rest are VC-02-20 implants.
 Combination Product: VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Other Name: PEC-Direct


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

  2. Change in C-peptide for Cohort 2 subjects [ Time Frame: Baseline to the Month 6 Visit ]
    Change in C-peptide from baseline.


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

Inclusion Criteria:

  • Men and non-pregnant women
  • Diagnosis of T1DM for a minimum of five (5) years
  • Hypoglycemia unawareness or significant glycemic lability
  • 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.
  • Six (6) 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
  • Detectable stimulated serum C-peptide during screening period assessment.
Contacts and Locations
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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): NCT03163511


Locations
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United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
UCLA-UCI Alpha Stem Cell Clinic
Irvine, California, United States, 92697
UC Davis - Alpha Stem Cell Clinic
Sacramento, California, United States, 95817
University of California San Diego
San Diego, California, United States, 92121
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43203
Belgium
University Hospital Brussels
Brussel, Belgium
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
ViaCyte
California Institute for Regenerative Medicine (CIRM)
Horizon 2020 - European Commission
Investigators
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Study Director: Richard Wang Vice President Clinical Operations
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT03163511    
Other Study ID Numbers: VC02-101
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases