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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
ViaCyte
ClinicalTrials.gov Identifier:
NCT02939118
First received: October 18, 2016
Last updated: NA
Last verified: October 2016
History: No changes posted
  Purpose
The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.

Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Three-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product

Resource links provided by NLM:


Further study details as provided by ViaCyte:

Primary Outcome Measures:
  • Incidence of adverse events reported during the study. [ Time Frame: 36 months ]

Estimated Enrollment: 200
Study Start Date: October 2016
Estimated Study Completion Date: November 2023
Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)
  Eligibility

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.
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT02939118     History of Changes
Other Study ID Numbers: VC01-201
Study First Received: October 18, 2016
Last Updated: October 18, 2016

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

ClinicalTrials.gov processed this record on April 28, 2017