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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02239354
First Posted: September 12, 2014
Last Update Posted: May 22, 2017
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.
Information provided by (Responsible Party):
ViaCyte
September 9, 2014
September 12, 2014
May 22, 2017
September 2014
January 2021   (Final data collection date for primary outcome measure)
  • Incidence of all adverse events reported during the study. [ Time Frame: Thru the Month 24 Visit ]
  • Change in C-peptide [ Time Frame: Baseline to the Month 6 Visit ]
Same as current
Complete list of historical versions of study NCT02239354 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Type 1 Diabetes Mellitus
Device: VC-01™ Combination Product
Biologic and Device
  • Experimental: Cohort 1
    2 VC-01 implants
    Intervention: Device: VC-01™ Combination Product
  • Experimental: Cohort 2
    4 or 6 VC-01 implants
    Intervention: Device: VC-01™ Combination Product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
January 2021
January 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02239354
VC01-101
Not Provided
Not Provided
Not Provided
ViaCyte
ViaCyte
Not Provided
Not Provided
ViaCyte
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP