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NCT06325566 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain

A Phase 3 study of Degenerative Disc Disease, sponsored by Mesoblast.

Recruiting
Registry status
Phase 3
Development phase
300
Enrollment target
20
Study locations

NCT06325566 is a Phase 3 study of Degenerative Disc Disease that is actively recruiting participants, run by Mesoblast. The registered enrollment target is 300 participants, above the 162-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (85% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT06325566, a Phase 3 study of Degenerative Disc Disease, is actively recruiting participants, sponsored by Mesoblast.

RECRUITING
Registry status
Phase 3
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Degenerative Disc Disease

Interventions

  • DRUG Saline
  • DRUG Rexlemestrocel-L + HA mixture

Study Locations (20)

California

  • TriWest Research Associates - Chula Vista
  • Boomerang Health Care - Concord
  • Memorial Orthopaedic Surgical Group - Long Beach
  • Newport Therapeutics - Newport Beach
  • University of California-Davis Spine Center - Sacramento
  • Innovative Pain Treatment Solutions - San Diego
  • University of California-San Francisco - San Francisco
  • Source Healthcare - Santa Monica

Florida

  • Prime Medical Research - Coral Gables
  • Cantor Spine Center at the Paley Orthopedic & Spine Institute - Fort Lauderdale
  • New Life Medical Research Center - Hialeah
  • Bold City Clinical Research - Jacksonville
  • OSSO Health, Inc. - Miami Beach
  • Interventional Pain Institute - The Villages
  • Conquest Research LLC - Winter Park

Arizona

  • Axsendo Clinical Research/Summa Pain Care - Phoenix
  • Pain Institute of Southern Arizona - Tucson

Georgia

  • Emory Healthcare - Dunwoody
  • Vista Clinical Research - Newnan

Colorado

  • Colorado Spine Partners/The Denver Spine and Pain Institute - Greenwood

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2024-07-03
Est. Completion 2027-10
Phase Phase 3

Sponsor

Mesoblast

25 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06325566

The ClinicalTrials.gov registry entry for NCT06325566 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 162-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (85% higher). The listed sponsor is Mesoblast, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.

NCT06325566 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT06325566 about?

NCT06325566 is a clinical study titled "Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain". 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...

What is the current status of trial NCT06325566?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2024-07-03. Estimated completion is 2027-10.

What conditions does trial NCT06325566 study?

This clinical trial studies the following conditions: Degenerative Disc Disease.

What interventions are being tested in trial NCT06325566?

The interventions under investigation include: Saline (DRUG), Rexlemestrocel-L + HA mixture (DRUG).

Who is sponsoring clinical trial NCT06325566?

This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06325566 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.