Efficacy of Intradiscal Injection of Viable Placental Tissue Extract in Subjects With One or Two Level, Symptomatic Lumbar Intervertebral Disc Degeneration

Dr. Parker (the "Investigator") and Semmes Murphey Foundation ("Foundation") are conducting
a study of outcomes and safety associated with degenerative discs at Semmes-Murphey Clinic,
P.C. ("Semmes-Murphey"). This study will look at a product that is derived from human
tissue, that will be injected into the affected disc. With this study, we hope to find a
safe and effective way to treat degenerative disc disease.

This study will compare injectable placental tissue extract called BioDGenesis ("Active
Product") to injectable Normal Saline ("Placebo"). The Active Product is supplied by BioD,
LLC ("BioD"). You have a 50 percent chance of receiving the Placebo

The study will last for 52 weeks. After all patients have been enrolled in the study and
have completed 26 weeks, the Investigator will conduct a safety and efficacy analysis. If
the investigator determines that the Active Product is more effective than Placebo in
treating degenerative disc disease and there are no safety concerns with the Active Product,
patients who received Placebo will have the option of receiving the Active Product through
week 52.

Inclusion Criteria:

1. The subject must be ≥18 and ≤75 years of age, skeletally mature, and have a BMI ≥18
kg/m2 and ≤30 kg/m2 at Screening.

2. The subject must have been experiencing low back pain for at least 6 months prior to
Screening.

3. The subject must have had low back pain that is unresponsive to at least 3 months of
conservative care (non operative treatment), which may include bed rest, anti
inflammatory or analgesic medications, chiropractic manipulations, acupuncture,
massage, physical therapy or home-directed lumbar exercise programs.

4. The subject must have pretreatment (Baseline) low back pain of 30 to 90 mm on the
visual analog scale (VAS) at Screening and Baseline.

5. The subject must have pretreatment (Baseline) Oswestry Disability Index Questionnaire
(ODI) score of 30 to 70 points at Screening and Baseline.

6. The subject's target disc must meet the following objective criteria (corresponding
to Pfirrman Grade 2 and 3):

7. The subject must be willing to voluntarily sign the informed consent form and agree
to the release of medical information for purposes of this study (i.e., HIPAA
authorization) at Screening.

8. The subject must be physically and mentally able to comply with the protocol, able to
read and complete the required forms, and willing and able to adhere to the
requirements of the protocol.

Exclusion Criteria:

1. The subject has radiculopathy resulting from nerve compression at Screening or
Baseline.

2. The subject has unilateral or bilateral leg pain with intensity greater than 50% of
the intensity of the low back pain as measured on a VAS at Screening or Baseline.

3. The subject has cauda equina syndrome at Screening or Baseline (Day 1).

4. The subject has greater than 50% loss of disc height when compared to the adjacent
superior disc.

5. The subject has a significant disc herniation or free fragment of disc material on
MRI.

6. The subject has current infection at the planned procedure site, active systemic
infection, or current or prior history of lumbar spinal infection (i.e., discitis,
septic arthritis, epidural abscess) at Baseline.

7. The subject has had previous lumbar spine surgery.

8. The subject has had previous disc treatment procedures or intradiscal injections.
Discography may have been performed, but the procedure must have been done at least 2
weeks or more prior to the injection of study medication.

9. The subject has undergone lumbar epidural or transforaminal injections with
corticosteroids within the last 3 months.

10. The subject has evidence of prior lumbar vertebral body fracture or trauma.

11. The subject has evidence of dynamic instability on lumbar flexion extension.

12. The subject has Grade 2 or higher spondylolisthesis or spondylolysis at the target
disc at Screening.

13. The subject has findings of a significant underlying neurological condition (motor
strength <4; sensory assessment abnormal; or reflexes absent or hyperactive with
clonus).

14. The subject has an active malignancy or tumor.

15. The subject has had significant systemic disease, such as unstable angina, autoimmune
disease, rheumatoid arthritis, diabetes mellitus, or muscular dystrophy.

16. The subject has a coagulopathy or thrombocytopenia.

17. The subject is currently taking anticoagulant, antineoplastic, antiplatelet, or
thrombocytopenia inducing medications (except for aspirin or nonsteroidal
anti-inflammatory drugs [NSAIDS]) at Baseline.

18. The subject is taking opioid analgesics regularly more than 2 times per day, or
taking long acting or long term opioids for more than 90 days at Baseline.

19. The subject has concomitant conditions requiring daily oral steroid usage for more
than 30 days in the preceding 90 days before Screening.

20. The subject has a history of unexplained, easy, or persistent bruising or bleeding,
bleeding from the gums, or bleeding problems experienced in previous surgical
procedures.

21. The subject has a history of hypersensitivity or anaphylactic reaction to bovine
products, HA, or dimethyl sulfoxide (DMSO).

22. The subject is currently using tobacco or has actively used tobacco within 3 months
prior to enrollment.

23. The subject has an uncontrolled psychiatric condition or substance/alcohol abuse that
would potentially interfere with the subject's participation in the study within 2
years prior to Screening.

24. The subject has participated in another drug or device clinical study within the 2
months immediately prior to Screening.

25. The subject is known to be pregnant or nursing at time of enrollment or with plans to
become pregnant within the planned length of the study.

26. The subject has pending litigation against a health care professional or other
pending civil litigation, except where required by the insurer as a condition of
coverage.

27. The subject has active or pending worker's compensation claims.

28. The subject has a body habitus that precludes adequate fluoroscopic visualization for
the procedure or the procedure is physically impossible.

29. The subject has a contraindication to MRI scanning or cannot tolerate MRI scanning.