AlloGen-LI Treatment of Spinal Stenosis

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02932020
• Other study ID #: HS-15-00576
• Status: Withdrawn
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Constriction, Pathologic
• Low Back Pain
• Spinal Stenosis

Intervention

Drug:
• AlloGen-LI
interlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI
• depomedrol
interlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml)

Device:
• MRI
contrast enhanced MRI of the lumbar spine performed at Visit 1 and Visit 6 weeks (+7 days)

Drug:
• 0.5% marcaine
epidural injection of 2mL 0.5% marcaine

Locations

Country	Name	City	State
United States	Keck School of Medicine of USC	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Vivex Biomedical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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