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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted:	September 9, 2014
First Posted:	September 12, 2014
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

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