Australia-based Mesoblast has begun subject enrolment in the Phase III clinical trial of rexlemestrocel-L for patients with chronic low back pain (CLBP) caused by inflammatory degenerative disc disease.
Rexlemestrocel-L is an allogeneic, immunoselected, and industrially produced stromal cell product.
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Subject enrolment is currently underway at various US sites.
The randomised, placebo-controlled will enrol 300 CLBP patients with inflammatory degenerative disc disease of less than five years duration.
The US Food and Drug Administration (FDA) approved the trial design and the 12-month primary endpoint of pain reduction.
Improvement in quality of life, and function and decline in opioid usage are some of the key secondary endpoints.
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By GlobalDataRexlemestrocel-L has obtained regenerative medicine advanced therapy (RMAT) designation from the FDA for the management of CLBP.
All of the advantages of fast track and breakthrough designations are available to products receiving RMAT designation, including rolling review and priority review upon filing a biologics licence application (BLA).
Mesoblast chief medical officer Dr Eric Rose said: “We are very excited to be actively enrolling our pivotal trial of rexlemestrocel-L across multiple sites and look forward to confirming the durable pain reduction previously observed in the first Phase III trial.
“There is a significant need for a safe, effective, and durable treatment in patients with CLBP and degenerative disc disease, in particular one that reduces or eliminates opioid use.”
Trial investigator at Coastal Health Specialty Care Dr Alan Miller said: “This therapy has the potential to be groundbreaking and life-changing for the low back pain population.”
In March this year, Mesoblast noted that its cell therapy Revascor (rexlemestrocel-L) for end-stage heart failure could be eligible for accelerated approval from the FDA.
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