Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (NCT06325566)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Axsendo Clinical Research/Summa Pain Care — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (40 Sites)
Showing the first 25 of 40 sites.
- Axsendo Clinical Research/Summa Pain Care — Phoenix, Arizona
- Pain Institute of Southern Arizona — Tucson, Arizona
- TriWest Research Associates — Chula Vista, California
- Boomerang Health Care — Concord, California
- Apex Research Group — Fair Oaks, California
- Memorial Orthopaedic Surgical Group — Long Beach, California
- Newport Therapeutics — Newport Beach, California
- University of California-Davis Spine Center — Sacramento, California
- Innovative Pain Treatment Solutions — San Diego, California
- University of California-San Francisco — San Francisco, California
- Source Healthcare — Santa Monica, California
- Colorado Spine Partners/The Denver Spine and Pain Institute — Greenwood, Colorado
- Cantor Spine Center at the Paley Orthopedic & Spine Institute — Fort Lauderdale, Florida
- New Life Medical Research Center — Hialeah, Florida
- Bold City Clinical Research — Jacksonville, Florida
- Interventional Pain Institute — The Villages, Florida
- Conquest Research LLC — Winter Park, Florida
- Emory Healthcare — Dunwoody, Georgia
- Vista Clinical Research — Newnan, Georgia
- Hawaii Pain & Spine — Kailua, Hawaii
- University of Kansas Medical Center — Kansas City, Kansas
- Iqra Research — Edgewood, Kentucky
- Paradigm Health System — Slidell, Louisiana
- The Kahan Center — Annapolis, Maryland
- Elevate Clinical Research — Rockville, Maryland
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.