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Phase 3, Pivotal, Multicentre, Randomised, Double-blind Controlled Study to Evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head

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Trial Profile

Phase 3, Pivotal, Multicentre, Randomised, Double-blind Controlled Study to Evaluate the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB) Implantation in Early Stage Non Traumatic Osteonecrosis of the Femoral Head

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2022

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At a glance

  • Drugs Autologous osteoblastic cell therapy Bone Therapeutics (Primary)
  • Indications Femur head necrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors BioSenic

    • Most Recent Events

    • 03 Jul 2019 Status changed from recruiting to discontinued.
    • 06 Nov 2018 According to a Bone Therapeutics media release,announces the conclusions of the Data and Safety Monitoring Board (DSMB) for the interim analysis of the Phase III osteonecrosis (ON) study of PREOB in 44 patients with a 12-month follow-up.
    • 06 Nov 2018 Results published in the Bone Therapeutics Media Release
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