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Trial record 13 of 21 for:    "Bone Disease" | "Prednisolone phosphate"

AlloGen-LI Treatment of Spinal Stenosis

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ClinicalTrials.gov Identifier: NCT02932020
Recruitment Status : Withdrawn
First Posted : October 13, 2016
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
Vivex Biomedical, Inc.
Information provided by (Responsible Party):
Wende Gibbs, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: AlloGen-LI Drug: depomedrol Device: MRI Drug: 0.5% marcaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
Study Start Date : October 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

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 Name: 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

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

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

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




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932020


Locations
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United States, California
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Vivex Biomedical, Inc.
Investigators
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Principal Investigator: Wende Gibbs, MD University of Southern California

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Responsible Party: Wende Gibbs, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02932020     History of Changes
Other Study ID Numbers: HS-15-00576
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wende Gibbs, University of Southern California:
disc herniation
spinal stenosis
Additional relevant MeSH terms:
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Bone Diseases
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Spinal Stenosis
Back Pain
Low Back Pain
Constriction, Pathologic
Pain
Neurologic Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical
Spinal Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids