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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

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

Latest Information Update: 14 Jan 2019

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At a glance

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

    • 17 Oct 2018 Planned number of patients changed from 65 to 69.
    • 27 Sep 2018 According to a ViaCyte Inc media release, the company have strengthened the collaboration with research partner and investor, W.L. Gore and Associates and announced positive data showing improved engraftment and function of the PEC-Encap product candidate in a clinically relevant non-clinical model. If the progress continues as expected, the company plan to resume enrollment in this trial for PEC-Encap as early as the first half of 2019.
    • 31 Aug 2018 Biomarkers information updated
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