A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
NCT ID: NCT03163511
Last Updated: 2024-12-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2017-07-06
2023-10-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
VC-02 Combination Product:
Up to ten (10) VC-02-20 implants and up to two (2) VC-02-300 implants
VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
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.
VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California Institute for Regenerative Medicine (CIRM)
OTHER
Horizon 2020 - European Commission
OTHER
Vertex Pharmaceuticals Incorporated
INDUSTRY
ViaCyte
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gautham Marigowda
Role: STUDY_DIRECTOR
Vice President, Clinical Development, Vertex
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope National Medical Center
Duarte, California, United States
UCLA-UCI Alpha Stem Cell Clinic
Irvine, California, United States
UC Davis - Alpha Stem Cell Clinic
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
University Hospital Brussels
Brussels, , Belgium
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Keymeulen B, De Groot K, Jacobs-Tulleneers-Thevissen D, Thompson DM, Bellin MD, Kroon EJ, Daniels M, Wang R, Jaiman M, Kieffer TJ, Foyt HL, Pipeleers D. Encapsulated stem cell-derived beta cells exert glucose control in patients with type 1 diabetes. Nat Biotechnol. 2024 Oct;42(10):1507-1514. doi: 10.1038/s41587-023-02055-5. Epub 2023 Nov 27.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VC02-101
Identifier Type: -
Identifier Source: org_study_id