AlloGen-LI Treatment of Spinal Stenosis

Withdrawn before enrolling · Not applicable

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT02932020

Run by

University of Southern California

People needed

0

Starts

2016-10-01

Expected to finish

2017-09-01

Last updated by the study team

2018-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).
• Patient is on anticoagulant medications (other than ASA). 14. Patient has eGFR of <40 15. Patient has known chronic kidney disease

Where it is running

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

Full record on ClinicalTrials.gov

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