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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 currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by ViaCyte
Sponsor:
Information provided by (Responsible Party):
ViaCyte
ClinicalTrials.gov Identifier:
NCT02239354
First received: September 9, 2014
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Type 1 Diabetes Mellitus
Device: VC-01™ Combination Product
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by ViaCyte:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02239354

Locations
United States, California
University of California at San Diego Recruiting
San Diego, California, United States
Contact: Study Coordinator    844-317-7836    alphastemcellclinic@ucsd.edu   
Additional Sites to be Added in Other Cities and States Not yet recruiting
TBD, California, United States
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Study Coordinator, (Canadian Residents Only)       parastoo@islet.ca   
Sponsors and Collaborators
ViaCyte
  More Information

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT02239354     History of Changes
Other Study ID Numbers: VC01-101
Study First Received: September 9, 2014
Last Updated: November 1, 2016

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

ClinicalTrials.gov processed this record on March 29, 2017