One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™
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ClinicalTrials.gov Identifier: NCT02939118 |
Recruitment Status :
Enrolling by invitation
First Posted : October 19, 2016
Last Update Posted : April 27, 2022
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Sponsor:
ViaCyte
Information provided by (Responsible Party):
ViaCyte
- Study Details
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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 |
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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 2023 |
Estimated Study Completion Date : | November 2023 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Type 1 diabetes
Primary Outcome Measures :
- 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, 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.
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.
No Contacts or Locations Provided
Responsible Party: | ViaCyte |
ClinicalTrials.gov 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:
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |