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)
BioRestorative Therapies
99 participants
Jun 30, 2022
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
Plain Language Summary
Simplified for easier understanding
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
Hypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate.
Sodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution
Locations(19)
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NCT04042844