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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

NCT03163511 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-12-03

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus With Hypoglycemia

Interventions

COMBINATION_PRODUCT

VC-02 Combination Product

PEC-01 cells loaded into a Delivery Device

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Horizon 2020 - European Commission

    collaborator OTHER

  • Vertex Pharmaceuticals Incorporated

    collaborator INDUSTRY

  • ViaCyte

    lead INDUSTRY

Principal Investigators

  • Gautham Marigowda · Vice President, Clinical Development, Vertex

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2023-10-13
Completion
2023-10-19
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163511 on ClinicalTrials.gov