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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

This study is currently recruiting participants.
Verified July 2017 by ViaCyte
Sponsor:
ClinicalTrials.gov Identifier:
NCT03163511
First Posted: May 23, 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 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 Intervention Phase
Type 1 Diabetes Mellitus With Hypoglycemia Combination Product: VC-02 Combination Product Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by ViaCyte:

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

Estimated Enrollment: 55
Actual Study Start Date: July 6, 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • 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
  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): NCT03163511


Locations
United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Study Coordinator    1-844-317-STEM (7836)    alphastemcellclinic@ucsd.edu   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Study Coordinator    612-626-4993    kreel001@umn.edu   
Sponsors and Collaborators
ViaCyte
  More Information

Responsible Party: ViaCyte
ClinicalTrials.gov Identifier: NCT03163511     History of Changes
Other Study ID Numbers: VC02-101
First Submitted: May 19, 2017
First Posted: May 23, 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
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