A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus
NCT ID: NCT04678557
Last Updated: 2023-10-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2019-06-25
2021-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Sentinel units (aka Cohort 1)
VC-01 Combination Product; Up to ten (10) VC-01 sentinels
VC-01 Combination Product
PEC-01 cells loaded into an Encaptra Drug Delivery System
Dose-finding units (aka Cohort 2)
VC-01 Combination Product; Up to twelve units implanted of which up to nine (9) are VC-01-DF (dose-finding) implants and the rest are VC-01 sentinels
VC-01 Combination Product
PEC-01 cells loaded into an Encaptra Drug Delivery System
Interventions
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VC-01 Combination Product
PEC-01 cells loaded into an Encaptra Drug Delivery System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of T1DM for a minimum of 3 years.
* Stable, optimized diabetic regimen
* Acceptable candidate for implant and explant procedures.
* Willing and able to comply with protocol requirements.
* Meet insulin dosing requirements per protocol
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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ViaCyte
INDUSTRY
Responsible Party
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Principal Investigators
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Manasi Jaiman, MD
Role: PRINCIPAL_INVESTIGATOR
ViaCyte, Inc.
Locations
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AMCR Institute
Escondido, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Texas Diabetes & Endocrinology
Austin, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VC01-103
Identifier Type: -
Identifier Source: org_study_id
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