AlloGen-LI Treatment of Spinal Stenosis

Study Overview
=================
Brief Summary
-----------------
In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft derived from amniotic fluid, injected into the epidural space at the level of spinal stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The effect of this treatment will be examined by patient reported changes in pain and disability utilizing validated outcome measures, and MRI imaging evaluating changes in contrast enhancement and T2 signal related to that reflect inflammation and degeneration.

Detailed Description
-----------------
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.

Official Title
-----------------
Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: AlloGen-LI
* Drug: depomedrol
* Device: MRI
* Drug: 0.5% marcaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain of > 4-5 weeks but < 6-7 months Evidence of at least mild lumbar stenosis /disc herniation on MRI Failure of conservative therapy to include physical therapy and pharmacotherapy Patient is at least 18 years of age Patient is willing to be blinded to treatment until after the 12 week post injection visit 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Randomized 10 subjects Visit 1: 1st contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine interlaminar epidural injection of (a) 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI Visit: 6 weeks (+7days): 2nd contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine | Drug: AlloGen-LI<br>* interlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI<br>* Other names: Interlaminar Epidural Injection-AlloGen-LI;Device: MRI<br>* contrast enhanced MRI of the lumbar spine performed at Visit 1 and Visit 6 weeks (+7 days)<br>Drug: 0.5% marcaine<br>* epidural injection of 2mL 0.5% marcaine<br>|
| Other: Group B<br>Randomized 10 subjects Visit 1: 1st contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine interlaminar epidural injection 2mL 0.5% marcaine and 1mL and 1mL steroid (depomedrol 80mg/ml). Visit 6 weeks (+7days): 2nd contrast enhanced Magnetic Resonance Imaging (MRI) scan of the lumbar spine | Drug: depomedrol<br>* interlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml)<br>* Other names: Interlaminar Epidural Injection-Standard;Device: MRI<br>* contrast enhanced MRI of the lumbar spine performed at Visit 1 and Visit 6 weeks (+7 days)<br>Drug: 0.5% marcaine<br>* epidural injection of 2mL 0.5% marcaine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | Cohen's d25 will be calculated at each permutation iteration. The empirical distribution of Cohen's d will then be calculated with a 95% confidence interval (CI). | 6-12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disc herniation, spinal stenosis