Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
Public ClinicalTrials.gov record NCT02412735. 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, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of Rexlemestrocel-L Alone or Combined With Hyaluronic Acid (HA) in Subjects With Chronic Low Back Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\> 6 months) associated with moderate radiographic degenerative changes of a disc.
Study identification
- NCT ID
- NCT02412735
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 404 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
- Mar 6, 2015 (Actual)
- Primary completion
- May 15, 2020 (Actual)
- Completion
- Jun 15, 2021 (Actual)
- Last update posted
- Oct 19, 2022
2015 – 2021
United States locations
- U.S. sites
- 47
- U.S. states
- 24
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Tennessee Valley Pain Consultants | Huntsville | Alabama | 35801 | — |
| Arizona Pain Specialists | Scottsdale | Arizona | 85258 | — |
| Physicians Research Group | Tempe | Arizona | 85284-2604 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020-4124 | — |
| Memorial Orthopaedics Surgical Group | Long Beach | California | 90806 | — |
| Newport Beach Headache and Pain | Newport Beach | California | 92660 | — |
| Institute for Regenerative Medicine and Clinical Research | Pasadena | California | 91105 | — |
| UC Davis Spine Center | Sacramento | California | 95816 | — |
| Orthopedic Pain Specialists | Santa Monica | California | 90403 | — |
| The Spine Institute | Santa Monica | California | 90403 | — |
| Summit Pain Alliance | Santa Rosa | California | 95401 | — |
| Integrated Pain Management | Walnut Creek | California | 94598 | — |
| Denver Back Pain Specialists, LLC | Greenwood Village | Colorado | 80111 | — |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | — |
| Coastal Clinical Research Specialists | Fernandina Beach | Florida | 32034 | — |
| Shrock Orthopedic Research, LLC | Fort Lauderdale | Florida | 33316 | — |
| Holy Cross Orthopedics Institute | Oakland Park | Florida | 33334 | — |
| Emory Orthopaedics & Spine Center | Atlanta | Georgia | 30329 | — |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | — |
| Injury Care Medical Center | Boise | Idaho | 83713 | — |
| Millennium Pain Center | Bloomington | Illinois | 61701 | — |
| Otrimed Clinical Research | Edgewood | Kentucky | 41017 | — |
| Orthopedic Specialists of Louisiana | Shreveport | Louisiana | 71103 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| MAPS Applied Research Center | Shakopee | Minnesota | 55379 | — |
| Innovative Pain Care Center | Las Vegas | Nevada | 89129 | — |
| University Clinical Research | Somerset | New Jersey | 08873 | — |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | — |
| Rochester Regional Health | Rochester | New York | 14626 | — |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | — |
| On Site Clinical Solutions, LLC | Morrisville | North Carolina | 28117 | — |
| The Center for Clinical Research/ Carolinas Pain Institute | Winston-Salem | North Carolina | 27103 | — |
| Cleveland Clinic | Cleveland | Ohio | 44106 | — |
| DOC Clinical Research | Dayton | Ohio | 45432 | — |
| Clinical Investigations, LLC | Edmond | Oklahoma | 73013 | — |
| Orthopaedic and Spine Specialists | York | Pennsylvania | 17402 | — |
| RI Hospital-Comprehensive Spine Center | Providence | Rhode Island | 02903 | — |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | — |
| Greenville Pharmaceutical Research, Inc. | Charleston | South Carolina | 29406 | — |
| Texas Back Institute | Plano | Texas | 75093 | — |
| Spine Team Texas | Southlake | Texas | 76092 | — |
| Precision Spine Care | Tyler | Texas | 75701 | — |
| Ericksen Research & Development, LLC | Bountiful | Utah | 84010 | — |
| the SMART Clinic | Draper | Utah | 84020 | — |
| Hope Research Institute | St. George | Utah | 84790 | — |
| Virginia iSpine Physicians, PC | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02412735, 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 Oct 19, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02412735 live on ClinicalTrials.gov.