Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Subject is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
Is at least 21 years of age;
Have central low back pain aggravated by movement and or postural changes (standing/sitting);
Have had back pain for at least 6 months, and have failed conservative management
One Grade III or IV (Pfirrmann Scale) degenerated lumbar disc;

Exclusion Criteria:

Current disc extrusion at any level in their lumbar spine; disc bulges or protrusions at any level in the lumbar spine resulting in nerve root compression;
Severe disc narrowing (equal to or more than 50% loss of disc height at the targeted level);
Type II or III Modic changes at any level;
Type I Modic changes at any level other than the targeted level;
Type I Modic changes at the treated level if maximum height of the changes is 25% or more of the vertebral body height;
Osteoporotic compression fracture at any vertebral level;
Lumbar Scheurmann's disease;
Antero or retrolisthesis ≥ 3mm at any level;
Currently experiencing chronic pain generating from any other source, which (in the judgment of the investigator) may interfere with the evaluation of back pain, and or disability;
Infection at the planned treatment site, history of systemic or local infection, which (in the investigator's judgment) may compromise subject participation and/or safety;
Currently diagnosed with immune-deficiency, which in the investigator's opinion may compromise subject participation and/or safety;
Receiving any immune-suppressant therapies other than short term steroid preparations;
BMI≥40;
Diagnosed with any comorbid conditions including: abnormal bleeding, AIDS, diabetes, hepatic or renal disease, and cardiopulmonary disorders such as COPD, MI and CHF; active malignancy or history of malignancy, or diseases of bone metabolism, which in the investigator's opinion may compromise subject participation and/or safety;
Has a history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or 3 or more Waddell Signs of nonorganic Behavior or any combination of variables in the Investigator's judgment that should exclude a potential subject;
Has pending litigation against a health care professional, except where required by the insurer as a condition of coverage, personal injury compensation or litigation claims;
Has active or pending workers' compensation claims;
Has contraindications for MRI.