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A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB) Implantation in Non-Infected Hypotrophic Non-Union Fractures

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Trial Profile

A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB) Implantation in Non-Infected Hypotrophic Non-Union Fractures

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 27 Dec 2022

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At a glance

  • Drugs Autologous osteoblastic cell therapy Bone Therapeutics (Primary)
  • Indications Non-union fracture
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors BioSenic
  • Most Recent Events

    • 03 Jul 2019 Status changed from active, no longer recruiting to discontinued.
    • 24 Jul 2018 Planned End Date changed from 1 Apr 2018 to 1 Apr 2019.
    • 19 Dec 2017 Status of trial is kept as active not recruiting as per investigators reply mentioning that competent authorities have been notified of the termination of the PREOB NU3 trial. As post treatment long-term safety follow-up is on-going, CT.gov status is active not recruiting. Patient still have to pass visit for safety purpose (last visit planned around April 2018). The study is effectively terminated for efficacy purpose since the last treated patient had the last efficacy visit.
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