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:

Information provided by (Responsible Party):

ViaCyte

ClinicalTrials.gov Identifier:

NCT02239354

First received: September 9, 2014

Last updated: May 18, 2017

Last verified: May 2017

History of Changes

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: 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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

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:	65
Actual Study Start Date:	September 2014
Estimated Study Completion Date:	January 2021
Estimated Primary Completion Date:	January 2021 (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
San Diego, California, United States
Additional Sites to be Added in Other Cities and States
TBD, 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
Study First Received:	September 9, 2014
Last Updated:	May 18, 2017

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 August 18, 2017

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