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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:
ClinicalTrials.gov Identifier:
NCT02939118
First Posted: October 19, 2016
Last Update Posted: October 20, 2016
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.
Information provided by (Responsible Party):
ViaCyte
  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

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.


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
No Contacts or Locations Provided
  More Information

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT02939118     History of Changes
Other Study ID Numbers: VC01-201
First Submitted: October 18, 2016
First Posted: October 19, 2016
Last Update Posted: October 20, 2016
Last Verified: October 2016

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