A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo

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.

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.