RecruitingPhase 2NCT04042844

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

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)

Sponsor

BioRestorative Therapies

Enrollment

99 participants

Start Date

Jun 30, 2022

Study Type

INTERVENTIONAL

Conditions

Lumbar Disc Disease

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a single injection of BRTX-100 — a treatment made from a patient's own bone marrow stem cells — directly into a damaged spinal disc as a potential way to relieve chronic low back pain from degenerative disc disease. It is a double-blind trial, meaning some participants receive the real injection and others receive a sham (fake) procedure for comparison. Adults aged 18 and older with at least six months of chronic lower back pain due to one or two degenerated discs, who have not improved after six or more months of conservative treatments like physical therapy, may be eligible. Participation involves a bone marrow collection, the disc injection (or sham), and follow-up visits at weeks 2, 12, 26, 52, and 104. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBRTX-100

Hypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate.

DRUGSaline

Sodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution

Locations(19)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Source Healthcare

Santa Monica, California, United States

Boomerang Healthcare

Walnut Creek, California, United States

Denver Back Pain Specialists, LLC

Greenwood Village, Colorado, United States

Cantor Spine Institute

Fort Lauderdale, Florida, United States

Coastal Health

Jacksonville, Florida, United States

Pain Relief Centers

St. Petersburg, Florida, United States

Tampa Pain Relief Center

Tampa, Florida, United States

Florida Pain Relief Center

Tampa, Florida, United States

Conquest Research

Winter Park, Florida, United States

Northwell Health

New York, New York, United States

The Center of Clinical Research, LLC

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Clinical Investigations LLC

Edmond, Oklahoma, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Science Connections

Austin, Texas, United States

NCP Center for Clinical Research and Innovation

Houston, Texas, United States

Precision Spine Care

Tyler, Texas, United States

Virginia iSpine Physicians

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04042844

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