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
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.
Description
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. Subjects randomized to active treatment will undergo bone marrow harvest…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Subject Inclusion Criteria: A subject is eligible for inclusion if all the following criteria are met: 1. A high index of suspicion for discogenic pain, (i.e., painful degenerative disc(s) with or without protrusions less than or equal to 5 mm) 1. Chronic Lower Back Pain for at least 6 months 2. Pain commonly provoked by prolonged sitting, forward bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers 3. Failure of at least 6 months of conservative back pain care (can include any or all of the following: rest, anti-inflammatory medication, analgesics, narcotics, epid…
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, LLCBirmingham, Alabama
- Source HealthcareSanta Monica, California
- Boomerang HealthcareWalnut Creek, California
- Denver Back Pain Specialists, LLCGreenwood Village, Colorado
- Cantor Spine InstituteFort Lauderdale, Florida
- Coastal HealthJacksonville, Florida