AlloGen-LI Treatment of Spinal Stenosis

NCT02932020 | Withdrawn

• 1 other identifier: HS-15-00576
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

disc herniation; spinal stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

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; Device: MRI; Drug: 0.5% marcaine

Group B

OTHER

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

Drug: depomedrol; Device: MRI; Drug: 0.5% marcaine

Interventions

AlloGen-LI DRUG

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

Also known as: Interlaminar Epidural Injection-AlloGen-LI

Group A

depomedrol DRUG

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

Also known as: Interlaminar Epidural Injection-Standard

Group B

MRI DEVICE

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

Group A; Group B

0.5% marcaine DRUG

epidural injection of 2mL 0.5% marcaine

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Southern California: lead
• VIVEX Biologics, Inc.: collaborator

Study Sites (1)

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Displacement; Spinal Stenosis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wende Gibbs, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)