A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
Phase of Trial: Phase III
Latest Information Update: 01 Dec 2017
At a glance
- Drugs Rexlemestrocel-L (Primary) ; Hyaluronic acid
- Indications Back pain; Intervertebral disc degeneration
- Focus Registrational; Therapeutic Use
- Sponsors Mesoblast
- 25 Aug 2016 According to a Mesoblast media release, FDA has provided written guidance and agreed for use of a composite primary endpoints for approval i.e. thresholds for pain (50% decrease in VAS) and function (15 point improvement in ODI), two time points (12 and 24 months) for meeting pain and functional improvement criteria and no intervention at the treated level through 24 months. The Company intends to conduct an interim analysis in this trial in Q1 2017.
- 19 Aug 2016 Planned End Date changed from 1 Dec 2017 to 1 Feb 2020.
- 19 Aug 2016 Planned primary completion date changed from 1 Dec 2017 to 1 Feb 2019.