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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.
 
ClinicalTrials.gov Identifier: NCT02939118
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2016
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
ViaCyte

Tracking Information
First Submitted Date October 18, 2016
First Posted Date October 19, 2016
Last Update Posted Date January 30, 2020
Actual Study Start Date November 7, 2016
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2017)
Incidence of adverse events reported during the study. [ Time Frame: 12 months ]
Original Primary Outcome Measures
 (submitted: October 18, 2016)
Incidence of adverse events reported during the study. [ Time Frame: 36 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™
Official Title A One-Year, Multicenter, Observational, Follow-up Safety Study in Subjects Previously Implanted With VC-01™ Combination Product
Brief Summary The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All subjects who have been exposed to implanted VC-01™ in any ViaCyte clinical trial.
Condition Type 1 Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: October 18, 2016)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02939118
Other Study ID Numbers VC01-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ViaCyte
Study Sponsor ViaCyte
Collaborators Not Provided
Investigators Not Provided
PRS Account ViaCyte
Verification Date January 2020