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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 : April 27, 2022
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

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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 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
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.
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Responsible Party: ViaCyte Identifier: NCT02939118    
Other Study ID Numbers: VC01-201
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases