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
Phase of Trial: Phase III
Latest Information Update: 18 Oct 2017
At a glance
- Drugs Autologous osteoblastic cell therapy Bone Therapeutics (Primary)
- Indications Femur head necrosis
- Focus Registrational; Therapeutic Use
- Sponsors Bone Therapeutics
- 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.