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A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 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: NCT03162926
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
ViaCyte

Tracking Information
First Submitted Date  ICMJE May 19, 2017
First Posted Date  ICMJE May 22, 2017
Last Update Posted Date October 18, 2018
Actual Study Start Date  ICMJE July 5, 2017
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
Incidence of all adverse events reported for subjects [ Time Frame: Thru the Month 4 Visit] ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03162926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Official Title  ICMJE An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
Brief Summary The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE Combination Product: VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery Device
Study Arms  ICMJE Experimental: Single-group
Up to six (6) VC-02-20 implants
Intervention: Combination Product: VC-02 Combination Product (aka PEC-Direct)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2017)
15
Actual Study Completion Date  ICMJE February 15, 2018
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and non-pregnant women of non-childbearing potential
  • Diagnosis of T1DM for a minimum of five (5) years
  • Stable diabetic treatment
  • Willingness to use a continuous glucose meter
  • Acceptable candidate for implantation

Exclusion Criteria:

  • History of islet cell, kidney, and/or pancreas transplant.
  • Two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
  • Uncontrolled or untreated thyroid disease or adrenal insufficiency
  • Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
  • Non-compliance with current anti-diabetic regimen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03162926
Other Study ID Numbers  ICMJE VC02-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ViaCyte
Study Sponsor  ICMJE ViaCyte
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ViaCyte
Verification Date October 2018

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