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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

Primary Purpose

Type 1 Diabetes Mellitus With Hypoglycemia

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VC-02 Combination Product
Sponsored by
ViaCyte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus With Hypoglycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope National Medical Center
  • UCLA-UCI Alpha Stem Cell Clinic
  • UC Davis - Alpha Stem Cell Clinic
  • University of California San Diego
  • Johns Hopkins University
  • University of Minnesota
  • Ohio State University
  • University Hospital Brussels
  • University of Alberta
  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to two (2) VC-02-300 implants

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.

Outcomes

Primary Outcome Measures

Incidence of all adverse events reported for Cohort 1 subjects
AEs through four months.
Change in C-peptide for Cohort 2 subjects
Change in C-peptide from baseline.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2017
Last Updated
May 24, 2023
Sponsor
ViaCyte
Collaborators
California Institute for Regenerative Medicine (CIRM), Horizon 2020 - European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03163511
Brief Title
A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViaCyte
Collaborators
California Institute for Regenerative Medicine (CIRM), Horizon 2020 - European Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus With Hypoglycemia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to two (2) VC-02-300 implants
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
VC-02 Combination Product
Other Intervention Name(s)
PEC-Direct
Intervention Description
PEC-01 cells loaded into a Delivery Device
Primary Outcome Measure Information:
Title
Incidence of all adverse events reported for Cohort 1 subjects
Description
AEs through four months.
Time Frame
Thru the Month 4 Visit
Title
Change in C-peptide for Cohort 2 subjects
Description
Change in C-peptide from baseline.
Time Frame
Baseline to the Month 6 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manasi Jaiman, MD, MPH
Organizational Affiliation
Chief Medical Officer, ViaCyte
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
UCLA-UCI Alpha Stem Cell Clinic
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
UC Davis - Alpha Stem Cell Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
University Hospital Brussels
City
Brussel
Country
Belgium
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35028608
Citation
Shapiro AMJ, Thompson D, Donner TW, Bellin MD, Hsueh W, Pettus J, Wilensky J, Daniels M, Wang RM, Brandon EP, Jaiman MS, Kroon EJ, D'Amour KA, Foyt HL. Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device. Cell Rep Med. 2021 Dec 2;2(12):100466. doi: 10.1016/j.xcrm.2021.100466. eCollection 2021 Dec 21.
Results Reference
derived
PubMed Identifier
34861146
Citation
Ramzy A, Thompson DM, Ward-Hartstonge KA, Ivison S, Cook L, Garcia RV, Loyal J, Kim PTW, Warnock GL, Levings MK, Kieffer TJ. Implanted pluripotent stem-cell-derived pancreatic endoderm cells secrete glucose-responsive C-peptide in patients with type 1 diabetes. Cell Stem Cell. 2021 Dec 2;28(12):2047-2061.e5. doi: 10.1016/j.stem.2021.10.003.
Results Reference
derived

Learn more about this trial

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

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