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

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 is testing BRTX-100, a treatment made from the patient's own bone marrow cells (specifically a type of stem cell), injected into a damaged spinal disc to treat chronic low back pain caused by degenerative disc disease. Degenerative disc disease occurs when the cushioning discs between the spinal vertebrae break down over time, causing persistent pain that can be debilitating. Unlike surgery, this minimally invasive injection aims to repair the disc from the inside by using the body's own regenerative cells. Patients must have failed at least 6 months of conservative treatments before enrolling. The study tracks pain reduction and functional improvement over 2 years. You may be eligible if: - You are 18 years or older with chronic low back pain for at least 6 months - You have degenerative disc disease confirmed by MRI - You have failed at least 6 months of conservative treatment (rest, medications, physical therapy, injections) - Your pain is between 40-80mm on a visual analog scale - Your disability score (ODI) is between 30-89 out of 100 You may NOT be eligible if: - You have had prior lumbar spine surgery (discectomy, fusion, laminectomy, etc.) - You have a bleeding disorder or cannot stop blood thinners for the procedure - Your BMI is 40 or above - You are pregnant or of childbearing potential without highly effective contraception - You have HIV, hepatitis C, or a known autoimmune disease affecting the musculoskeletal system Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

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.

Visit

NCT04042844


Related Trials