Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
NCT ID: NCT05516992
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
417 participants
INTERVENTIONAL
2022-08-19
2025-08-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SB-01 For Injection
Subjects receive a SB-01 For Injection intradiscal injection per treated disc.
SB-01 For Injection
Intradiscal injection
Sham Needle
Subjects receive a sham needle placement for each treated disc.
Sham Needle
Sham needle placement
Interventions
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SB-01 For Injection
Intradiscal injection
Sham Needle
Sham needle placement
Eligibility Criteria
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Inclusion Criteria
2. Back pain greater than 'worst leg pain' as measured by the NRS
3. Diagnosed with one or two contiguous level(s) lumbar (L1-S1) disc degeneration of Pfirrmann Grade 3 and/or 4 determined by MRI analyzed by the independent radiologic central lab
4. Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment
5. Baseline ODI score ≥ 40/100
6. Baseline NRS ≥ 4 points (Back)
7. Willing and able to provide Informed Consent for study participation
8. Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet
9. Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects):
1. Abstinence or,
2. Surgical Sterilization or,
3. Oral Contraceptives or,
4. Barrier Methods (Condoms, IUD's).
10. Patient must verify that:
1. In the case of females, the patient is post-menopausal or is surgically sterile or,
2. In the case of males, the patient is surgically sterile or,
3. The patient (male or female) confirms that they are at a point in their life where they are beyond consideration of having children.
Exclusion Criteria
2. Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty, spinal cord stimulator, others)
3. Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
4. Prior fracture at any lumbar level
5. Significant neurologic symptoms:
1. Grade 3/5 or lower strength in any lumbar myotome
2. Sensory deficit in a clearly radicular or sensory dermatome
6. MRI evidence of disc height loss \> 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
7. MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
8. MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
9. MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
10. MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
11. MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
12. Spondylolisthesis (antero or retrolisthesis) \> 25% at any level, determined by the independent radiologic central lab
13. Lumbar coronal deformity, determined by the independent radiologic central lab:
a. L1-S1 regional deformity \> 25 degrees
14. Spondylolysis at any level
15. Lumbar inflammatory spondylitis
16. Recent history (previous six months) of chemical or alcohol dependence
17. Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
18. Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score \> 33 or Zung \> 17 and the Modified Somatic Perception Questionnaire (MSPQ) score \> 12
19. Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40)
20. A QT duration corrected for heart rate by Fridericia's formula (QTcF) \> 470 millisecond (msec)
21. Active systemic infection
22. Infection at the site of procedure pre-operatively
23. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
24. Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, in the opinion of the Principal Investigator compromise a subject's ability to comply with study procedures, and/or confound data
25. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease)
26. Any disease, condition or surgery which might impair healing, such as:
1. Active malignancy
2. History of metastatic malignancy
27. Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
28. Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit)
29. Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels
30. Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up
31. Currently a prisoner
32. Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure
33. Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation
34. Patient cannot be currently using the prohibited medications listed in the protocol
18 Years
ALL
No
Sponsors
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MCRA
INDUSTRY
Spine BioPharma, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Gilligan, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Spine Center
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Evolve Clinical Research
Phoenix, Arizona, United States
Neurovations Research
Napa, California, United States
Source Healthcare
Santa Monica, California, United States
Science Connections, LLC
Doral, Florida, United States
Coastal Clinical Research
Jacksonville, Florida, United States
Conquest Research
Orlando, Florida, United States
Conquest Research
Orlando, Florida, United States
Pain Relief Centers
St. Petersburg, Florida, United States
Tampa Pain Relief Center
Tampa, Florida, United States
Florida Pain Relief Group
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Vista Clinical Research, LLC
Newnan, Georgia, United States
Injury Care Research
Boise, Idaho, United States
The Orthopaedic Research Foundation, Inc (OrthoIndy)
Indianapolis, Indiana, United States
Abay Neuroscience Center
Wichita, Kansas, United States
OrthoNebraska
Omaha, Nebraska, United States
Pioneer Clinical Research
New York, New York, United States
Meta Medical Research Institute
Cincinnati, Ohio, United States
META Medical Research Institute
Dayton, Ohio, United States
The Orthopedic Center
Tulsa, Oklahoma, United States
HD Research
Bellaire, Texas, United States
NeuroCare Partners
Houston, Texas, United States
South Texas Spinal Clinic
San Antonio, Texas, United States
Precision Spine Care
Tyler, Texas, United States
Tranquil Clinical Research
Webster, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Virginia iSpine Physicians
Richmond, Virginia, United States
Gershon Pain Specialists
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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SB01-M001
Identifier Type: -
Identifier Source: org_study_id
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