Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

NCT04042844 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 99 participants
Start Date 2022-06-30
Est. Completion 2027-12
Phase Phase 2

Sponsor

BioRestorative Therapies

1 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04042844 reports 19 study locations spanning 11 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04042844?

The interventions under investigation include: Saline (DRUG), BRTX-100 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04042844?

This trial is sponsored by BioRestorative Therapies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial