Clinical Trial Details

NCT ID: NCT02239354
Date Last Changed: November 1, 2016

Overview

Research Study Summary

A clinical trial to evaluate treatments using VC-01™ Combination Product for patients with Type 1 Diabetes Mellitus

Research Study 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

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.

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Recruitment Details

Phase
1/2
Gender
All
Age
18 to 55 Years
Overall Status
Recruiting
Lead Sponsor
ViaCyte
Duration
35 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 55 Years

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

Site Locations (2)

Country State City Zip Facility and Contact
United States California San Diego University of California at San Diego
Study Coordinator
844-317-7836
alphastemcellclinic@ucsd.edu
Canada Alberta Edmonton T6G 2B7 University of Alberta Hospital
Study Coordinator, (Canadian Residents Only)
parastoo@islet.ca

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