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Trial record 2 of 2 for:    Viacyte | Recruiting Studies

A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

This study is currently recruiting participants.
Verified July 2017 by ViaCyte
Sponsor:
ClinicalTrials.gov Identifier:
NCT03162926
First Posted: May 22, 2017
Last Update Posted: July 11, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ViaCyte
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Mellitus Combination Product: VC-02 Combination Product (aka PEC-Direct) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ 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 for subjects [ Time Frame: Thru the Month 4 Visit] ]

Estimated Enrollment: 15
Actual Study Start Date: July 5, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-group
Up to six (6) VC-02-20 implants
Combination Product: VC-02 Combination Product (aka PEC-Direct)
PEC-01 cells loaded into a Delivery 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 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT03162926


Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Study Coordinator    780-407-1501    parastoo@islet.ca   
Sponsors and Collaborators
ViaCyte
  More Information

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT03162926     History of Changes
Other Study ID Numbers: VC02-102
First Submitted: May 19, 2017
First Posted: May 22, 2017
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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