A Prospective Study of NuCel® in Cervical Spine Fusion

The study is intended to demonstrate that the NuCel® allograft is effective and safe in
promoting bone growth and fusion rate when used in cervical fusion in patients with one, two
or three-level diseases of the cervical spine. Sixty subjects will participate in the study
at a single clinical site. Participants will be at least 21 years of age. All subjects will
have been established with cervical spine disease at one, two or three levels of the
cervical spine that requires cervical interbody fusion per the opinion of the treating
surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone
graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when
used in cervical fusion surgery. Success based on findings of cervical CT scan and plain
radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and
patient satisfaction will be used as secondary outcome measures.

Inclusion Criteria:

1. Be at least 21 years of age

2. Have clinical and radiological evidence of degenerative disc disease, spondylosis,
spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical
spine.

3. In the opinion of the treating surgeon, must already be a qualified candidate for
cervical fusion surgery.

4. Be likely to return for regular follow-ups until the end of the study period.

5. Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

1. Neck pain due to acute trauma.

2. Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or
chronic infection, malignancy, other space occupying lesions and metabolic bone
demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).

3. Any terminal or autoimmune disease including but not limited to HIV infection, or
rheumatoid arthritis.

4. Any other concurrent medical disease or treatment that might significantly impair
normal healing process as evaluated by the PI.

5. Recent history (within past 6 months) of any chemical or alcohol dependence requiring
treatment.

6. Currently a prisoner.

7. Currently experiencing a major mental illness (psychosis, schizophrenia, major
affective disorder) which may indicate that the symptoms are psychological rather
than of physical origin.

8. Pregnancy at the time of enrollment.

9. In order to confirm eligibility, subjects previously diagnosed with osteoporosis,
osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal
female subjects under the age of 65 with any of the risk factors for osteoporosis,
and subjects at the investigator's discretion will have DEXA scans performed prior to
study entry. If DEXA is required, exclusion will be defined as a DEXA bone density
measurement T score ≤ -2.5