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A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

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: NCT02239354
Recruitment Status : Terminated (Insufficient functional product engraftment)
First Posted : September 12, 2014
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
Sponsor:
Collaborator:
California Institute for Regenerative Medicine (CIRM)
Information provided by (Responsible Party):
ViaCyte

Study Description
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Brief Summary:
The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Combination Product: VC-01™ Combination Product Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
2 VC-01™ Combination Product implants
 Combination Product: VC-01™ Combination Product
Biologic and Device
Experimental: Cohort 2
4 or 6 VC-01™ Combination Product implants
 Combination Product: VC-01™ Combination Product
Biologic and Device


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events Reported During the Study. [ Time Frame: Thru the Month 24 Visit ]
  2. Change in C-peptide [ Time Frame: Baseline to the Month 6 Visit ]
    The Full Analysis Set (FAS) is the intent-to-treat (ITT) set of subjects. This set is defined as all T1DM subjects who were enrolled into the study and received implantation of at least one VC-01-250 or sentinel unit on Study Day 1. The FAS (Cohort 2 T1DM subjects who meet the FAS criteria) will be used to analyze the primary efficacy endpoint.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women (non-pregnant and non-childbearing potential)
  • Diagnosis of type 1 diabetes mellitus for at least 3 years
  • Stable diabetic treatment
  • Willingness to use a continuous glucose meter
  • Acceptable candidate for implantation

Exclusion Criteria:

  • Advanced complications associated with diabetes
  • Immunosuppressive therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239354


Locations
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United States, California
University of California at San Diego
San Diego, California, United States
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
ViaCyte
California Institute for Regenerative Medicine (CIRM)
  Study Documents (Full-Text)

Documents provided by ViaCyte:
Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT02239354    
Other Study ID Numbers: VC01-101
First Posted: September 12, 2014    Key Record Dates
Results First Posted: March 24, 2022
Last Update Posted: March 24, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases