A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 3 Study to Determine the Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade (KLG) 2 or 3 Osteoarthritis of the Knee
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 04 Jul 2017
At a glance
- Drugs Tonogenchoncel-L (Primary)
- Indications Osteoarthritis
- Focus Registrational; Therapeutic Use
- Sponsors TissueGene
- 26 Jun 2017 Status changed from planning to not yet recruiting.
- 01 Nov 2016 According to a TissueGene media release, received a Special Protocol Assessment designation for this trial. Company anticipated to initiate this trial in the second quarter of 2017.
- 15 May 2015 According to a TissueGene media release, it has reached an agreement with the US Food and Drug Administration regarding Special Protocol Assessment (SPA) for this trial. As per SPA, data from the trial will be used as the basis for submission of a Biologics License Application.