MedTrace Logo

AlloGen-LI Treatment of Spinal Stenosis

NCT02932020 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-05-11

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

DRUG

AlloGen-LI

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

DRUG

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

Sponsors & Collaborators

  • VIVEX Biologics, Inc.

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Wende Gibbs, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932020 on ClinicalTrials.gov