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

a study on Diabetes Diabetes Type 1 Hypoglycemia Unawareness

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

VC02-101 will evaluate an experimental cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes and Hypoglycemia Unawareness.

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

Details

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.

Keywords

Type 1 Diabetes Mellitus With Hypoglycemia Diabetes Mellitus Diabetes Mellitus, Type 1 Hypoglycemia VC-02 Combination Product

Eligibility

You can join if…

Open to people ages 18-65

  • Men and non-pregnant women
  • Diagnosis of T1DM for a minimum of five (5) years
  • Hypoglycemia unawareness or significant glycemic lability
  • Stable diabetic treatment
  • Willingness to use a continuous glucose meter
  • Acceptable candidate for implantation

You CAN'T join if...

  • 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
  • Detectable stimulated serum C-peptide during screening period assessment.

Locations

  • UCLA-UCI Alpha Stem Cell Clinic accepting new patients
    Irvine California 92697 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ViaCyte
ID
NCT03163511
Phase
Phase 1/2
Study Type
Interventional
Last Updated
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