Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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: 12 Feb 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

Most Recent Events

  • 18 Jan 2026 According to Mesoblast media release, after the FDA's Type B meeting review of data from this trial, the company has received USFDA feedback on potential filing of a Biologics License Application (BLA) for rexlemestrocel-L in patients with chronic discogenic low back pain (CLBP). FDA acknowledged that the effects on pain intensity in 12 months appear to favor the active arm.
  • 05 Nov 2025 According to Mesoblast media release, the company has scheduled a meeting with the U.S. Food & Drug Administration (FDA) in early December to discuss the trial data on opioid reduction and cessation of rexlemestrocel-L in patients with chronic low back pain (CLBP).
  • 26 Feb 2025 According to a Mesoblast media release, primary endpoint (12-month primary endpoint of pain reduction as an approvable indication) has been met.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top