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NCT04042844 · ClinicalTrials.gov registry record · Phase 2
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
A Phase 2 study of Lumbar Disc Disease, sponsored by BioRestorative Therapies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 19
- Study locations
NCT04042844 is a Phase 2 study of Lumbar Disc Disease that is actively recruiting participants, run by BioRestorative Therapies. The registered enrollment target is 99 participants. The trial reports 19 study locations across 11 states.
The verdict
NCT04042844, a Phase 2 study of Lumbar Disc Disease, is actively recruiting participants, sponsored by BioRestorative Therapies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 19
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Saline
- BIOLOGICAL BRTX-100
Study Locations (19)
Florida
- Cantor Spine Institute - Fort Lauderdale
- Coastal Health - Jacksonville
- Pain Relief Centers - St. Petersburg
- Tampa Pain Relief Center - Tampa
- Florida Pain Relief Center - Tampa
- Conquest Research - Winter Park
Texas
- Science Connections - Austin
- NCP Center for Clinical Research and Innovation - Houston
- Precision Spine Care - Tyler
California
- Source Healthcare - Santa Monica
- Boomerang Healthcare - Walnut Creek
Alabama
- Alabama Clinical Therapeutics, LLC - Birmingham
Colorado
- Denver Back Pain Specialists, LLC - Greenwood Village
New York
- Northwell Health - New York
North Carolina
- The Center of Clinical Research, LLC - Winston-Salem
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-06-30 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04042844
The ClinicalTrials.gov registry entry for NCT04042844 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioRestorative Therapies, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lumbar Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT04042844 reports 19 study locations spanning 11 distinct geographic areas - top geographies include Florida, Texas, California.
Frequently Asked Questions
What is clinical trial NCT04042844 about?
NCT04042844 is a clinical study titled "A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)". 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 degenerat...
What is the current status of trial NCT04042844?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2022-06-30. Estimated completion is 2027-12.
What conditions does trial NCT04042844 study?
This clinical trial studies the following conditions: Lumbar Disc Disease.
What interventions are being tested in trial NCT04042844?
The interventions under investigation include: Saline (DRUG), BRTX-100 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04042844?
This trial is sponsored by BioRestorative Therapies, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04042844 being conducted?
This trial has 19 study locations across Alabama, California, Colorado, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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