A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Public ClinicalTrials.gov record NCT04042844. 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 Phase 2, Double-Blind, Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a double-blind, controlled, randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.
Study identification
- NCT ID
- NCT04042844
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 99 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
- Jun 29, 2022
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2027
- Last update posted
- Aug 25, 2025
2022 – 2027
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | Withdrawn |
| Source Healthcare | Santa Monica | California | 90403 | Recruiting |
| Boomerang Healthcare | Walnut Creek | California | 94598 | Recruiting |
| Denver Back Pain Specialists, LLC | Greenwood Village | Colorado | 80111 | Recruiting |
| Cantor Spine Institute | Fort Lauderdale | Florida | 33306 | Withdrawn |
| Coastal Health | Jacksonville | Florida | 32257 | Recruiting |
| Pain Relief Centers | St. Petersburg | Florida | 33709 | Recruiting |
| Tampa Pain Relief Center | Tampa | Florida | 33603 | Recruiting |
| Florida Pain Relief Center | Tampa | Florida | 33614 | Recruiting |
| Conquest Research | Winter Park | Florida | 32789 | Recruiting |
| Northwell Health | New York | New York | 10022 | Recruiting |
| The Center of Clinical Research, LLC | Winston-Salem | North Carolina | 27103 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Clinical Investigations LLC | Edmond | Oklahoma | 73013 | Withdrawn |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29406, | Withdrawn |
| Science Connections | Austin | Texas | 78758 | Recruiting |
| NCP Center for Clinical Research and Innovation | Houston | Texas | 77008 | Recruiting |
| Precision Spine Care | Tyler | Texas | 75701 | Withdrawn |
| Virginia iSpine Physicians | Richmond | Virginia | 23235 | Recruiting |
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 NCT04042844, 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 Aug 25, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04042844 live on ClinicalTrials.gov.