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
- 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.