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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: Recruiting Phase 3 study of Degenerative Disc Disease, sponsored by Mesoblast.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-07-03 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What NCT06325566 shows while recruiting
NCT06325566 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 162-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (85% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06325566's enrollment target sits among peer trials
300 7th of 42 higher than 36 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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