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AlloGen-LI Treatment of Spinal Stenosis

Primary Purpose

Low Back Pain

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AlloGen-LI

depomedrol

MRI

0.5% marcaine

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring disc herniation, spinal stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Keck School of Medicine of USC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02932020

First Posted

October 4, 2016

Last Updated

May 9, 2018

Sponsor

University of Southern California

Collaborators

VIVEX Biologics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02932020

Brief Title

AlloGen-LI Treatment of Spinal Stenosis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Withdrawn

Study Start Date

October 2016 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

Collaborators

VIVEX Biologics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

disc herniation, spinal stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Arm Title

Group B

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

AlloGen-LI

Other Intervention Name(s)

Interlaminar Epidural Injection-AlloGen-LI

Intervention Description

interlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI

Intervention Type

Drug

Intervention Name(s)

depomedrol

Other Intervention Name(s)

Interlaminar Epidural Injection-Standard

Intervention Description

interlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml)

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.5% marcaine

Intervention Description

epidural injection of 2mL 0.5% marcaine

Primary Outcome Measure Information:

Title

Pain Reduction

Description

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).

Time Frame

6-12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wende Gibbs, MD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keck School of Medicine of USC

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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AlloGen-LI Treatment of Spinal Stenosis

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