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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs Rexlemestrocel-L (Primary) ; Hyaluronic acid
  • Indications Back pain; Intervertebral disc degeneration
  • Focus Registrational; Therapeutic Use
  • Sponsors Mesoblast

Most Recent Events

  • 26 Feb 2025 According to Mesoblast media release, the 12-month primary endpoint of pain reduction as an approvable indication was successfully met in Mesoblast's first Phase 3 trial. Key secondary measures include improvement in quality of life and function.
  • 30 Jan 2024 According to Mesoblast media release, results from this study will provide FDA with a clinical data package that may result in product approval.
  • 09 Jun 2022 According to Mesoblast media release, data from this trial will be presented at Mesoblast Key Opinion Leader Event.

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