AlloGen-LI Treatment of Spinal Stenosis

AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of
osteorarthritis and degenerative disc disease. Anti-inflammatory components include
inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and
interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues,
including amniotic fluid, amniotic membrane and chorion are regulated as human cell and
tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft
materials for human injection. AlloGen-LI is derived from placental tissues obtained from
carefully screened healthy mothers at the time of scheduled cesarean section. The mothers
have agreed to donate the tissues, which would otherwise be discarded. The experimental
treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural
space under CT guidance, in an identical manner to traditional epidural steroid /marcaine
injections.

Inclusion Criteria:

1. Low back pain of > 4-5 weeks but < 6-7 months

2. Evidence of at least mild lumbar stenosis /disc herniation on MRI

3. Failure of conservative therapy to include physical therapy and pharmacotherapy

4. Patient is at least 18 years of age

5. Patient is willing to be blinded to treatment until after the 12 week post injection
visit

6. Patient is willing and able to review and sign the study informed consent form

Exclusion Criteria:

1. No evidence of lumbar stenosis or disc herniation on MRI 2. Patient has had prior lumbar
surgery at any level 3. Patient has received epidural steroid injection in the past 6
months 4. Patient currently receives systemic steroids for another medical condition 5.
Patient is pregnant 6. Patient has systemic infection at the proposed injection site 7.
Patient has a systemic malignancy 8. Current therapy with any immunosuppressive medication
9. History of solid organ or hematologic transplantation 10 History of autoimmune disorder
11. Patient has known allergy to lidocaine, marcaine or steroid 12. Devices and conditions
that are contraindications for MRI examination (routinely screened before all MRI
examinations).

13. Patient is on anticoagulant medications (other than ASA). 14. Patient has eGFR of <40
15. Patient has known chronic kidney disease