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

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ClinicalTrials.gov Identifier: NCT03163511
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
ViaCyte

Brief Summary:
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus With Hypoglycemia Combination Product: VC-02 Combination Product Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: There are two Cohorts in this study design. Cohort 1 enrolls up to 15 subjects total. After Cohort 1 enrollment is completed, Cohort 2 enrollment then occurs with up to an additional 40 subjects.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label, First-In-Human Study Evaluating the Safety, Tolerability, and Efficacy of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to two (2) VC-02-300 implants
Combination Product: VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Other Name: PEC-Direct

Experimental: Cohort 2
VC-02 Combination Product; Up to six (6) VC-02-20 implants and up to four (4) VC-02-300 implants
Combination Product: VC-02 Combination Product
PEC-01 cells loaded into a Delivery Device
Other Name: PEC-Direct




Primary Outcome Measures :
  1. Incidence of all adverse events reported for Cohort 1 subjects [ Time Frame: Thru the Month 4 Visit ]
  2. Change in C-peptide for Cohort 2 subjects [ Time Frame: Baseline to the Month 6 Visit ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
  • At least one (1) severe hypoglycemic event in previous 12 months
  • Hypoglycemia unawareness or significant glycemic lability
  • 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.
  • Six (6) 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

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): NCT03163511


Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Study Coordinator    844-317-7836    alphastemcellclinic@ucsd.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Study Coordinator    410-614-0905    doluka1@jhmi.edu   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Study Coordinator    612-626-4993    kreel001@umn.edu   
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43203
Contact: Study Coordinator    614-688-6885    ashley.mintos@osumc.edu   
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Study Coordinator    780-407-1501    parastoo@islet.ca   
Canada, British Columbia
University of British Columbia Enrolling by invitation
Vancouver, British Columbia, Canada
Sponsors and Collaborators
ViaCyte

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT03163511     History of Changes
Other Study ID Numbers: VC02-101
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

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
Hypoglycemia
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms