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
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
- 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.