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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2017

At a glance

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

    • 08 Jun 2017 According to a Bone Therapeutics media release, planned number of patients changed from 130 to 118.
    • 08 Jun 2017 According to a Bone Therapeutics media release, interim results from the 12-month follow up are expected in third quarter of 2018. If the results from this interim analysis suggest a strong efficacy signal for PREOB, the study recruitment could be terminated prematurely.
    • 08 Jun 2017 According to a Bone Therapeutics media release, the recruitment of the 44 treated patients required for the planned interim analysis is complete.
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