NCT02939118

Brief Summary

The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

November 7, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

7.3 years

First QC Date

October 18, 2016

Last Update Submit

April 22, 2024

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events reported during the study.

    12 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects who have been exposed to implanted VC-01™ in any ViaCyte clinical trial.

You may qualify if:

  • Previous implantation of VC-01™ combination product with subsequent explantation of all VC-01 units.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 19, 2016

Study Start

November 7, 2016

Primary Completion

February 8, 2024

Study Completion

February 8, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04