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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 : Active, not recruiting
First Posted : September 12, 2014
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Device: VC-01™ Combination Product Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of all 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 ]

Eligibility Criteria

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

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
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
More Information

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT02239354     History of Changes
Other Study ID Numbers: VC01-101
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

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