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Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
NCT06325566 · View on ClinicalTrials.gov ↗
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
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mesoblast, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06325566 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06325566?
The interventions under investigation include: Saline (DRUG), Rexlemestrocel-L + HA mixture (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06325566?
This trial is sponsored by Mesoblast, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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