Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain

This is a, prospective, randomized, parallel-arm, multicenter study that will enroll up to
220 evaluable patients at up to 15 clinical sites. The outcomes of this trial will be based
on assessment of primary and secondary endpoints at 6 and 12 months after treatment of
supplementary allograft compared to conservative care in subjects who have pain attributable
to disc degeneration as judged by MRI scoring (Pfirrmann), physical examination, and patient
reported pain.

The study is composed of two phases - the Screening Phase (enrollment) followed by the Active
Phase (12 months). There is an indeterminate overlap of up to 14 days between the end of the
Screening Phase and the start of the Active Phase for individual subjects in order to
evaluate the protocol, and consent to their participation. After completing the Informed
Consent procedure, screening and study specific procedures can be performed. Only patients
that meet the entry criteria for both phases are eligible and can participate in this study.

During the 14 days of the Screening Phase (Day -14 to Day 0), subjects will be assessed for
study eligibility to establish their baseline condition, and will be randomized to either
conservative care (maintaining current level of care), or be provided with supplementary
allograft transplantation (Day 0 of the Screening Phase), or receive placebo treatment
(saline). All subjects who are randomized to conservative care in the Screening Phase (Day
-14 to Day 0), will be evaluated as per standard of care and will be assessed along with
those who are selected for eligibility to enter the Active Phase of allograft
transplantation.

The first 24 subjects randomized (at least 4 subjects from each group) will return to the
clinic for a safety assessment 1 month after treatment. Subsequent clinic visits will occur
at 6 and 12 months following treatment for safety and efficacy assessments. Subjects
randomized to conservative care will additionally receive a clinical follow-up at 3 months to
assess pain, change, or loss of function since their initial visit.

Inclusion Criteria:

- Able to provide an English written Informed Consent

- Age 18 to 60 years inclusive

- Male or female

- Body mass index <35

- Pfirrmann Grade [3-6]

- Radiographic confirmation by MRI/X-ray of:

1. translational instability defined as ≤5 mm, or

2. angular instability defined as ≤5°

- Back pain (with or without radicular leg pain) measured by:

1. ODI of at least 40%, and

2. VASPI of at least 40mm

- Pathologic level between L1 and S1

- 1 or 2 vertebral level involvement that has been evaluated for at least 6 months and
treated with conservative care

- Symptomatic back pain attributable to intervertebral disc for a minimum of 6 months

- No previous surgical treatment at the disc level(s) being considered

- Psychosocially, mentally and physically able to fully comply with this protocol, and
follow-up schedule

- Ability to undergo allograft transplantation

- Life expectancy >2 years

- No contraindications to MRI

- No history of malignancy (basal cell carcinoma) or chronic infectious disease (e.g.
HIV, Hepatitis)

- Agree to use appropriate contraception; not planning on becoming pregnant for 24
months after treatment

- Patient disc for transplant confirmed by inter-discal pressure measurement, or
disc-imaging study.

- No signs or symptoms of infection

- No chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs
prior to treatment

Exclusion Criteria:

- Seropositive or seronegative spondyloarthropathy

- Type III Modic changes

- Prior surgeries of segments between L1 and S1

- Chemonucleolysis or percutaneous laserectomy of the affected disc prior to the study

- Chronic facet syndrome

- Stenosis of the spinal canal that is moderate to severe or more in degree

- Spondylodiscitis

- Spondylolisthesis (lysis and degenerative)

- Severe motor deficit or cauda equina disorder based on investigator determination

- Congenital abnormalities of the spinal nerves

- Pelvic and inguinal angiopathy

- Neurogenic inguinal syndrome

- Syringomyelia

- Diastematomyelia

- Traumatic neurological disorders

- Diseases of the kidney (nephritis, pyelonephritis)

- Other severe diseases of any other major body system as judged by the investigator

- Regular intake of systemic steroids

- Malignant diseases of any solid organ or any hematologic malignancy during the
previous 5 years

- Patients who have participated in a clinical trial within the last month prior to
inclusion

- Moderate to severe or greater lumbar stenosis of both transplantation endplates and
adjacent levels