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NCT02939118 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02939118
Other study ID # VC01-201
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2016
Est. completion date February 8, 2024

Study information
Verified date April 2024
Source ViaCyte
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date February 8, 2024
Est. primary completion date February 8, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
ViaCyte

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events reported during the study. 12 months
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