A Prospective, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Combined With HA in Subjects With Moderate to Severe Chronic Low Back Pain (HyaluronicAcid)

NCT06325566 Phase 3 RECRUITING

The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into a lumbar intervertebral disc compared to control through 12 months post-treatment.

Details

Lead sponsor	Mesoblast, Ltd.
Phase	Phase 3
Status	RECRUITING
Enrolment	300
Start date	2024-07-03
Completion	2027-10

Conditions

• Degenerative Disc Disease

Interventions

• Rexlemestrocel-L + HA mixture
• Saline

Primary outcomes

• Mean Change From Baseline in Daily Average Low Back Pain at 12 Months Post-treatment Based on Visual Analog Scale (VAS) Score — Baseline and Month 12
  Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.
• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to Month 24

Countries

United States