A Pilot Phase 1/2a, Multicentre, Open Proof-of-concept Study on the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Implantation in Non-infected Delayed-Union Fractures

Trial Profile

A Pilot Phase 1/2a, Multicentre, Open Proof-of-concept Study on the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Implantation in Non-infected Delayed-Union Fractures

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Aug 2017

At a glance

  • Drugs Allogeneic osteoblastic cell therapy Bone Therapeutics (Primary)
  • Indications Fracture
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Bone Therapeutics
  • Most Recent Events

    • 11 May 2017 According to Bone Therapeutics media release, this Study is targeting the recruitment of 32 patients, but is flexible and could be stopped prematurely after a positive evaluation of the interim data analysis of the first 16 patients which is expected in September 2017.
    • 11 May 2017 According to Bone Therapeutics media release, recruitment of 16 patients is completed in this study.
    • 11 Apr 2017 Planned End Date changed from 1 Jul 2017 to 1 Apr 2018.
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