Actively Recruiting
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Led by BioRestorative Therapies · Updated on 2025-08-26
99
Participants Needed
19
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Diagnosis of chronic lumbar disc disease with back and/or radicular pain confirmed by history, physical exam, and imaging
- Chronic lower back pain lasting at least 6 months
- Pain triggered by activities like sitting, bending, lifting, twisting, coughing, sneezing, or Valsalva maneuvers
- Failure of at least 6 months of conservative back pain care including medications, injections, or physical therapy
- Low back pain visual analog scale (VAS) score between 40 and 80 mm at screening
- Oswestry Disability Index (ODI) score between 30 and less than 90 at screening
- No significant localized pain below the beltline without lumbar pain
- Thigh or leg pain, if present, is nonradicular
- Diagnostic medial branch block or facet joint injection in the last 12 months indicating no prevailing facet joint involvement
- Degenerative disc disease confirmed by MRI with specific Pfirrmann scores and Modic changes
- Maintained intervertebral disc height of at least 50% on MRI
- Discography performed if multiple discs are degenerative and symptomatic disc unclear
- Willing and able to provide written informed consent
- No contraindications to the procedure such as pregnancy, active infection, bleeding disorder, or metastatic cancer
You will not qualify if you...
- Spinal deformity including scoliosis 20 degrees or greater, spondylolysis, significant retrolisthesis or spondylolisthesis
- Disc extrusions, sequestered fragments, facet cysts, or greater than moderate spinal stenosis on MRI
- Grade V annular fissure at index disc level if discography performed
- Modified Pfirrmann Grade 8 or higher on MRI
- Bleeding disorders or required anticoagulation that cannot be interrupted
- Platelet count 100,000 or less
- INR 1.5 or greater
- Extreme obesity with BMI 40 or greater
- Clinically relevant spinal instability on flexion-extension films
- Previous lumbar spine surgery or interventions such as discectomy, laminectomy, fusion, or intradiscal therapies
- Acute or chronic lumbosacral spine fracture
- Lumbosacral epidural steroid injections within 1 month prior to consent
- Planned use of systemic NSAIDs within 72 hours prior to treatment
- Known hypersensitivity or anaphylaxis to dimethyl sulfoxide (DMSO)
- Active significant non-lumbosacral spinal orthopedic pain including hip, knee, or cervical disc disease
- Widespread or ill-defined myofascial pain
- Treatment with cellular or biological investigational therapy within 6 months or plans to participate in such trials during follow-up
- Previous lumbosacral intervertebral disc injection for therapy
- Recent inpatient treatment for alcohol or drug abuse within 6 months
- Ongoing poorly controlled psychological or somatic disease
- Social or geographical barriers to study compliance
- Known autoimmune diseases affecting musculoskeletal or neurological systems
- Required chronic immunosuppression
- Positive hepatitis C or HIV test
- Pregnant or lactating women
- Women of childbearing potential not using highly effective contraception
- Abnormal lab values including elevated bilirubin, liver enzymes, low neutrophils, low hemoglobin, or reduced kidney function
- Other active medical or psychiatric illnesses affecting safety or evaluation
- Inability to comply with study requirements
- Active workers compensation or litigation related to lumbosacral pain
- History of drug or alcohol abuse or noncompliance with controlled substances
- Regular long-term daily opioid use of 30 MME or more
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Withdrawn
2
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
3
Boomerang Healthcare
Walnut Creek, California, United States, 94598
Actively Recruiting
4
Denver Back Pain Specialists, LLC
Greenwood Village, Colorado, United States, 80111
Actively Recruiting
5
Cantor Spine Institute
Fort Lauderdale, Florida, United States, 33306
Withdrawn
6
Coastal Health
Jacksonville, Florida, United States, 32257
Actively Recruiting
7
Pain Relief Centers
St. Petersburg, Florida, United States, 33709
Actively Recruiting
8
Tampa Pain Relief Center
Tampa, Florida, United States, 33603
Actively Recruiting
9
Florida Pain Relief Center
Tampa, Florida, United States, 33614
Actively Recruiting
10
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
11
Northwell Health
New York, New York, United States, 10022
Actively Recruiting
12
The Center of Clinical Research, LLC
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
13
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Clinical Investigations LLC
Edmond, Oklahoma, United States, 73013
Withdrawn
15
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29406,
Withdrawn
16
Science Connections
Austin, Texas, United States, 78758
Actively Recruiting
17
NCP Center for Clinical Research and Innovation
Houston, Texas, United States, 77008
Actively Recruiting
18
Precision Spine Care
Tyler, Texas, United States, 75701
Withdrawn
19
Virginia iSpine Physicians
Richmond, Virginia, United States, 23235
Actively Recruiting
Research Team
F
Francisco Silva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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