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
  • University of California San Diego in progress, not accepting new patients
    San Diego California 92121 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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