One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT02939118
• Lead Sponsor: ViaCyte

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Study Start: 2016-11-07
• Primary Completion: 2024-02-08
• Study Completion: 2024-02-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

Exclusion Criteria

• There are no exclusion criteria for this trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events reported during the study.	12 months