| Eligibility |
Inclusion Criteria:
- Persons of childbearing potential must be non-nursing and have a negative serum
pregnancy test to be included in the trial and will agree to use adequate
contraception (hormonal or barrier method or abstinence) from the time of screening to
a period of up to 18 months following completion of the drug treatment cycle. Persons
of childbearing potential are defined as premenopausal and not surgically sterilized,
or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed
prior to the administration of the study drug to confirm negative results. If the
urine pregnancy test is positive, the study drug will not be administered, and the
result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be
performed at a central clinical laboratory, whereas urine pregnancy tests will be
performed by qualified personnel using a kit. Persons becoming pregnant during the
study will continue to be monitored for the duration of the study or completion of the
pregnancy, whichever is longer. Monitoring will include perinatal and neonatal
outcomes. Any SAEs associated with pregnancy will be recorded. The requirement for
radiation (X-ray) will be removed.
- Clinical diagnosis of symptomatic facet joint arthropathy involving the L1-S1 facets.
- Radiographic evidence of facet arthropathy involving the L1-S1 facets.
- Chronic low back pain with or without referred pain to the buttock, groin, or proximal
thigh.
- Chronic low back pain is defined as the following:
- Low back pain for at least 6 months;
- Failed at least 3 months of conservative back pain care. Conservative treatment
regimens may include any or all of the following: initial rest, medications e.g.,
anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants, massage,
acupuncture, osteopathic or chiropractic manipulations, activity modification,
home-directed lumbar exercise program, and non-invasive pain control treatments
or procedures;
- Have at a minimum undergone supervised physical therapy, such as daily walking
routines, therapeutic exercises, and back education programs specifically for the
treatment of low back pain AND taken a pain medication for back pain (e.g., NSAID
and/or opioid medication);
- Low back pain of at least 30mm and not more than 90mm of 100mm on low back pain
VAS (average pain over 24 hours). If present, radicular leg pain associated with
nerve root impingement = 30mm in both legs on a 100mm VAS scale;
- ODI score of at least 20 and no more than 90 on a 100-point percentage scale.
- Confirmation of facet joint related pain by medial branch block with positive results.
Positive results are defined as at least 75% improvement on pain, after one block with
lidocaine and the other with either bupivacaine or ropivacaine.
- Full understanding of the requirements of the study and willingness to comply with the
treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits
and assessments.
- Can provide written informed consent and complete HIPAA documentation after the nature
of the study is fully explained and prior to any study-related procedure.
Exclusion Criteria:
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
- Subjects who are pregnant or nursing or subjects planning to become pregnant during
the study. If a subject becomes pregnant during the study, the subject will remain in
the study and only the requirement for radiation (x-ray) will be removed.
- Subjects with current or prior history of spinal infection at the symptomatic level
(e.g. discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Subjects with a diagnosis of severe osteoporosis with pathological fracture.
- Radiofrequency ablation at the index level prior to injection in the past 1 months
with positive results. Positive results are defined as at least 50 % pain improvement
on VAS back pain scale.
- Any lumbar facet intra-articular injection including steroids at the index facet level
prior to treatment injection in the past 1 months, except for the following injections
performed at least 2 weeks prior to study treatment:
- Contrast medium (diagnostic injection);
- Nerve-blocking anesthetics (e.g., lidocaine, bupivacaine);
- Antibiotics;
- Saline;
- NSAIDs.
- Subjects that have undergone a procedure affecting the structure/biomechanics of the
index facet joint or a spinal fusion adjacent to the symptomatic level. The
investigator will determine whether the procedure or spinal fusion has affected the
structure/biomechanics of the index facet joint.
- Have undergone any procedure within 12 months of the study enrollment using biological
treatment for any condition such as bone marrow aspirate concentrate, PRP, bone
marrow-derived MSCs, adipose-derived MSCs, SVF, micro fragmented fat, embryonic
membrane product etc.
- Clinically relevant instability on flexion-extension as determined by the primary
investigator by overlaying films.
- Have an acute fracture of the spine at the time of enrollment in the study or
clinically compromised vertebral bodies at the affected level due to current or past
trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae, with
the exception of Pars Fractures.
- Presence of any of the following spinal deformities: spondylolysis at the
corresponding facet level, spondylolisthesis > Grade II at the index facet.
- Epidural steroid injections within 4 weeks prior to treatment injection.
- Active malignancy or tumor as a source of symptoms or history of malignancy prior to
enrollment in the study, except history of basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or squamous cell carcinoma of the cervix if fully excised
and with clear margins.
- An average baseline morphine equivalent dose (MED) of > 50mg/day, as determined by the
investigator during Screening consultation.
- Taking systemic immunosuppressant medications or having a chronic, immunosuppressive
state.
- Taking anti-rheumatic disease medication (including methotrexate or other
antimetabolites) within 3 months prior to study enrollment.
- Clinically significant abnormal hematology (complete blood count with differential),
blood chemistry, or urinalysis screening laboratory results, including AST, ALT,
alkaline phosphatase (ALP), bilirubin, creatinine, CRP, and ESR. Clinical significance
is to be determined upon investigator's discretion.
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis,
and syphilis.
- Unexplained fever, defined as greater than 100.4 degrees Fahrenheit or 38.0 degrees
Celsius, or mental confusion at baseline.
- Clinically significant cardiovascular (e.g., history of myocardial infarction,
congestive heart failure or uncontrolled hypertension > 120 mmHg diastolic and/or 180
mmHg systolic), neurological (e.g., stroke, TIA) renal, hepatic or endocrine disease
(e.g., diabetes). Clinical significance is to be determined upon investigator's
discretion.
- Participation in a study of an experimental drug or medical device for treatment of
facet joint arthropathy within one year.
- Any contraindication to MRI according to MRI guidelines or unwillingness to undergo
fluoroscopic procedures
- History of or current evidence of alcohol or drug abuse or dependence, recreational
use of illicit drug or prescription medications, or have use of medical marijuana
within 30 days of study entry, as determined by the investigator during Screening
consultation.
- Any illness or condition which, in the investigators' judgment will interfere with the
patient's ability to comply with the protocol, compromise patient safety, or interfere
with the interpretation of the study results.
- Being involved in active litigation related to subject's low back pain.
- Have a mental illness that could prevent completion of the study or protocol
questionnaires.
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