AlloGen-LI Treatment of Spinal Stenosis

May 9, 2018 updated by: Wende Gibbs, University of Southern California

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of USC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

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
interlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI
Other Names:
  • Interlaminar Epidural Injection-AlloGen-LI
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
Other: Group B

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
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
Drug: depomedrol
interlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml)
Other Names:
  • Interlaminar Epidural Injection-Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Reduction
Time Frame: 6-12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

VIVEX Biologics, Inc.

Investigators

  • Principal Investigator: Wende Gibbs, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-15-00576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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