Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Chronic low back pain for more than 6 months w/ low back component greater than leg pain.
Average pain of at lest 40/100 on VAS pre-procedure.
Inadequate response to at least 6 months of conservative care including medication, physical therapy and/or spinal injection
Advanced imaging of MRI or CT demonstrating abnormal disc pathology
Presumed lumbar disc pain based on either positive discogram or patient must have MRi findings of either high intensity zone and/or Type 1 or 2 Modic endplate changes, or exclusion of other sources of pain.
Having provided informed consent

Exclusion Criteria:

Active moderate to severe lumbar radiculopathy
Negative discogram
Very severe decrease in disc height at planned injection level (disc height of less than 1/3 expected)
Active infection
Moderate to severe anemia, thrombocytopenia or leukopenia
Spinal fracture within the past 6 months
Severe psychological illness
Inability to consent to the procedure due to cognitive issues
Prior surgery at a level considered to be the source of pain
Lumbar surgery within the past 6 months
Women who are pregnant or breast feeding
Prior intradiscal therapeutic injection or procedure
Severe uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease or any medical condition which would make the subject unsuitable for this study.
Inflammatory arthritis
Any cancer within the past 5 years, except basal cell or squamous cell skin cancer
Intradural disc herniation
Coagulopathy preventing spinal injection
Inability to stop anticoagulants other than aspirin due to other medical issues
Exceeds 30 mg morphine equivalent per day of opioid use.
A history of alcohol or drug abuse within the past 5 years.
Use of any investigational drug within the past 30 days.
Steroid injection in the spine within the past 30 days.
Discography within the last 21 days
A known allergy or sensitivity to heparin or citrate (used for processing BMC)
Pending litigation involving the subject's back pain.
Active worker's compensation claim
Central stenosis at a level to be injected with an AP diameter less than or equal to 5 mm
Severe anaphylactic/anaphylactoid reaction to any of the medications used. (If a patient does have a mild or moderate allergy to any of the medications used in the procedure or prior anaphylactic/anaphylactoid reaction to any food or drug, they will be given prednisone 50 mg PO 13, 7, and 1 hour prior to the procedure and diphenhydramine 50mg PO 1 hour prior to the procedure.)
In order to mitigate any economic risk, a patient without adequate medical insurance coverage for any subsequent tests or procedures deemed clinically necessary will be excluded. BMC is an autologous blood product with multiple clinical uses. Intradiscal administration should not preclude insurance coverage for any subsequent medical issues that might develop pertaining to the intradiscal injection itself or the BMC