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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02939118
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2016
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):

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

Condition or disease
Type 1 Diabetes Mellitus

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Incidence of adverse events reported during the study. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects who have been exposed to implanted VC-01™ in any ViaCyte clinical trial.

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.

Responsible Party: ViaCyte Identifier: NCT02939118     History of Changes
Other Study ID Numbers: VC01-201
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases