Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
Public ClinicalTrials.gov record NCT06325566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06325566
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 3, 2024 (Actual)
- Primary completion
- Jul 2027 (Estimated)
- Completion
- Jul 2028 (Estimated)
- Last update posted
- Jun 17, 2026
2024 – 2028
United States locations
- U.S. sites
- 40
- U.S. states
- 21
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Axsendo Clinical Research/Summa Pain Care | Phoenix | Arizona | 85085 | — |
| Pain Institute of Southern Arizona | Tucson | Arizona | 85710 | — |
| TriWest Research Associates | Chula Vista | California | 91910 | — |
| Boomerang Health Care | Concord | California | 94520 | — |
| Apex Research Group | Fair Oaks | California | 95628 | — |
| Memorial Orthopaedic Surgical Group | Long Beach | California | 90806 | — |
| Newport Therapeutics | Newport Beach | California | 92660 | — |
| University of California-Davis Spine Center | Sacramento | California | 95816 | — |
| Innovative Pain Treatment Solutions | San Diego | California | 92111 | — |
| University of California-San Francisco | San Francisco | California | 94143 | — |
| Source Healthcare | Santa Monica | California | 90403 | — |
| Colorado Spine Partners/The Denver Spine and Pain Institute | Greenwood | Colorado | 80111 | — |
| Cantor Spine Center at the Paley Orthopedic & Spine Institute | Fort Lauderdale | Florida | 33306 | — |
| New Life Medical Research Center | Hialeah | Florida | 33012 | — |
| Bold City Clinical Research | Jacksonville | Florida | 32224 | — |
| Interventional Pain Institute | The Villages | Florida | 32162 | — |
| Conquest Research LLC | Winter Park | Florida | 32789 | — |
| Emory Healthcare | Dunwoody | Georgia | 30338 | — |
| Vista Clinical Research | Newnan | Georgia | 30265 | — |
| Hawaii Pain & Spine | Kailua | Hawaii | 96734 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Iqra Research | Edgewood | Kentucky | 41017 | — |
| Paradigm Health System | Slidell | Louisiana | 70458 | — |
| The Kahan Center | Annapolis | Maryland | 21401 | — |
| Elevate Clinical Research | Rockville | Maryland | 20852 | — |
| Oasis Clinical Research | Las Vegas | Nevada | 89121 | — |
| Reno Tahoe Pain Associates | Reno | Nevada | 89511 | — |
| University of Rochester | Rochester | New York | 14611 | — |
| Eximia EquiHealth Research LLC/Emerge Ortho | Durham | North Carolina | 27704 | — |
| AdventHealth Hendersonville | Hendersonville | North Carolina | 28792 | — |
| Meta Medical Research Institute, LLC | Dayton | Ohio | 45432 | — |
| Clinical Investigations, LLC | Edmond | Oklahoma | 73034 | — |
| OSS Health | York | Pennsylvania | 17402 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | — |
| Institute of Precision Pain Medicine | Corpus Christi | Texas | 78414 | — |
| Paradigm Research Center/Houston Scoliosis and Spine Institute | Houston | Texas | 77030 | — |
| Axsendo Clinical Research/Texas Institute of Pain and Spine | Pearland | Texas | 77584 | — |
| VA iSpine Physicians | Richmond | Virginia | 23238 | — |
| West Virginia University | Martinsburg | West Virginia | 25401 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06325566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06325566 live on ClinicalTrials.gov.