a study comparing the safety and effectiveness of cartilage cell injected into the lumbar disc as compared to a placebo

Conditions: Degenerative Disc Disease

Summary: this is a clinical study to collect safety and preliminary efficiency information on the use of nuqu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.

this is a phase ii clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (nuqu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. this to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.

Eligibility 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.

Keywords: back pain intervertebral disc lumbar spine