A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01 Combination Product in Subjects With Type 1 Diabetes Mellitus

Trial Profile

A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01 Combination Product in Subjects With Type 1 Diabetes Mellitus

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 May 2017

At a glance

  • Drugs Pancreatic beta cell replacement therapy-ViaCyte (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Acronyms STEP ONE
  • Sponsors ViaCyte
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 18 May 2017 Planned number of patients changed from 40 to 65.
    • 18 May 2017 Planned primary completion date changed from 1 Aug 2017 to 1 Jan 2021.
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