A Prospective, Randomized, Double‑Blinded, Vehicle‑ and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single‑Level, Symptomatic Lumbar Intervertebral Disc Degeneration
Phase of Trial: Phase I/II
Latest Information Update: 07 Jan 2019
At a glance
- Drugs Injectable-discogenic-cell-therapy-DiscGenics (Primary)
- Indications Intervertebral disc degeneration
- Focus Adverse reactions; First in man; Therapeutic Use
- Sponsors DiscGenics
- 07 Jan 2019 According to a DiscGenics media release, this trial passed its initial planned safety review, where an independent data safety monitoring committee (DSMC) reviewed the first six subjects, and reported there were no safety issues and recommended to continue the trial with no changes to the protocol.
- 16 Mar 2018 Planned End Date changed from 1 Nov 2020 to 1 Apr 2021.
- 16 Mar 2018 Planned primary completion date changed from 1 Nov 2019 to 1 Apr 2020.