Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, Designed to Determine the Efficacy, Safety, and Tolerability of Intramuscular Administration of Allogeneic PLX-PAD Cells for the Treatment of Muscle Injury Following Arthroplasty for Hip Fracture
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 12 Mar 2018
At a glance
- Drugs PLX PAD (Primary)
- Indications Muscle injury
- Focus Registrational; Therapeutic Use
- Sponsors Pluristem Therapeutics
- 12 Mar 2018 Status changed from planning to not yet recruiting.
- 26 Sep 2017 According to a Pluristem Therapeutics media release, the company plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months. The company plans to use results of trial to achieve marketing approval in both the U.S. and Europe.
- 26 Sep 2017 According to a Pluristem Therapeutics media release, the company has received a positive feedback on the proposed study design and endpoints of the trial from the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA).