A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Phase of Trial: Phase III
Latest Information Update: 02 Apr 2019
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At a glance
- Drugs Autologous chondrocyte implantation (Primary)
- Indications Cartilage disorders; Knee injuries
- Focus Registrational; Therapeutic Use
- Sponsors Histogenics Corporation
- 27 Mar 2019 Status changed from active, no longer recruiting to discontinued.
- 21 Dec 2018 According to a Histogenics Corporation media release, based on the feedback received from the FDA, the FDA indicated that an additional clinical trial would need to be completed before it would accept a submission of a Biologics License Application (BLA) for NeoCart. However, considering the time and funding required to conduct such a trial, Histogenics expects to suspend the development of NeoCart and does not plan to submit a BLA at this time.
- 06 Dec 2018 Planned primary completion date changed from 1 Sep 2018 to 1 Jun 2020.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History