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The SAFE Trial. Sterile Amniotic Fluid Filtrate Epidural Injection.

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ClinicalTrials.gov Identifier: NCT04537026
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Cell Therapy & Regenerative Medicine
SKAGGs Foundation
Information provided by (Responsible Party):
Zack McCormick, University of Utah

Brief Summary:
There is a large population of patients with lumbosacral radicular pain due to spinal stenosis who do not respond to physical therapy or oral medication management, yet wish to avoid spinal surgery or are simply not candidates due to medical co-morbidity. Given the natural history of lumbar spinal stenosis, these patients typically suffer from chronic pain and disability. Currently, the typical treatment for this population is serial corticosteroid injection. The efficacy of the treatment specifically for the indication of spinal stenosis is in question and is associated with both concerning chronic sequelae and the risk, although low, of catastrophic neurologic compromise. Alternatively, hAF is a promising new biologic treatment with neuro-protective and regenerative properties. Early studies demonstrate its anti-inflammatory properties, with high levels of anti-inflammatory cytokines, in addition to its ability to assist with regeneration of peripheral nerves. Furthermore, it has a favorable side-effect profile without concern for long-term sequelae or potential for neurologic compromise. The present study aims to determine if epidural injection of hAF compared to the corticosteroid dexamethasone is more effective for the treatment of lumbosacral radicular pain due to spinal stenosis, as measured by pain, disability, psychological function, oral analgesic use, and avoidance of surgery. Evidence for superiority of epidural hAF compared to dexamethasone injection would change the treatment paradigm for refractory radicular pain due to spinal stenosis. Furthermore, even if shown to be non-inferior to epidural dexamethasone, epidural hAF would be favored given its superior safety profile. Thus, this research has the potential to improve outcomes and patient safety in a very large population with chronic pain.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Drug: Amniotic Fluid Allograft Drug: Dexamethasone sodium phosphate Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A Double-blinded, randomized, prospective study to evaluate the standard of care (Corticosteriod) vs. Sterile Amniotic Fluid Filtrate Epidural Injection for the treatment of Lumbosacral Radicular Pain due to Spinal Stenosis.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Participants, study investigators, and research personnel collecting data will remain blinded to patient treatment allocation.

participants will be randomized to group #1 or #2 based on a random computer-generated schedule. Participants will be blinded to the group to which they are randomized. The physician preforming the injection will also be blinded to group. Research personnel will prepare the study drug and SOC medication such that the physician and patient cannot distinguish between groups. Identical syringes will be used in both groups, and both dexamethasone and hAF are colorless, translucent, odorless liquids, which are indistinguishable in a syringe. However, unblinded research personnel will prepare the study drug injection and maintain the blind by placing a blank label over the syringe to ensure that the treatment is blinded to the patient and treating physician.

Primary Purpose: Treatment
Official Title: A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis: The SAFE Trial (Improving Safety and Outcomes in the Treatment of Pain and Disability Related to Spinal Stenosis).
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : January 20, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transforaminal epidural Amniotic Fluid injection
Using fluoroscopic guidance, a lumbosacral epidural injection will be performed. 2-5cc of 1% lidocaine will be injected into the skin and subcutaneous tissue to anesthetize the skin and subcutaneous structures over the site of planned entry to the neural foramen. A 22 or 25 g Whitacre needle (3.5-7") will be used to access the epidural space using the sub-pedicular or infraneural transforaminal approach, depending on individual anatomy at the discretion of the treating physician. Needle tip position will be confirmed using anterior-posterior and lateral fluoroscopic views as well as with injection of a standard 1-3 mL aliquot of omnipaque 180 (Iohexol) (GE Healthcare) contrast material during live fluoroscopy to confirm epidural flow of contrast and to rule out an intravascular injection. Then 3 mL of Amniotic Fluid will be injected through the spinal needle for unilateral symptoms, for a total injection volume of 3 mL in both groups.
Drug: Amniotic Fluid Allograft
Amniotic Fluid Allograft will be mixed with sterile water and injected using transforaminal approach

Active Comparator: Transforaminal epidural dexamethasone injection
Using fluoroscopic guidance, a lumbosacral epidural injection will be performed. 2-5cc of 1% lidocaine will be injected into the skin and subcutaneous tissue to anesthetize the skin and subcutaneous structures over the site of planned entry to the neural foramen. A 22 or 25 g Whitacre needle (3.5-7") will be used to access the epidural space using the sub-pedicular or infraneural transforaminal approach, depending on individual anatomy at the discretion of the treating physician. Needle tip position confirmed using anterior-posterior and lateral fluoroscopic views as well as with injection of a standard 1-3 mL aliquot of omnipaque 180 (Iohexol) (GE Healthcare) contrast material during live fluoroscopy to confirm epidural flow of contrast and to rule out an intravascular injection. 1 mL of dexamethasone sodium phosphate (10 mg/mL) combined with 2 mL of sterile water will be injected through the spinal needle for unilateral symptoms, for a total injection volume of 3 mL in both groups.
Drug: Dexamethasone sodium phosphate
Dexamethasone phosphate mixed with sterile water will be injected by transforaminal approach




Primary Outcome Measures :
  1. The number of adverse events associated with the drug injection. [ Time Frame: 2 years ]
    Categorical measures of both pain and function will be used for the primary outcome analysis given recent recommendations by the National Institute of Health.

  2. The percentage of participants reporting >50% improvement in NRS pain score at 6 weeks; back and leg pain separately. [ Time Frame: 6 weeks ]
    Categorical measures of both pain and function will be used for the primary outcome analysis given recent recommendations by the National Institute of Health.

  3. The percentage of participants reporting >30% improvement in SSSQ score at 6 weeks. [ Time Frame: 6 weeks ]
    Categorical measures of both pain and function will be used for the primary outcome analysis given recent recommendations by the National Institute of Health.



Information from the National Library of Medicine

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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. Patients who are ≥ 18 years old
  2. Pain in the low back and lower extremity (pain NRS >4) with buttock/leg pain > back pain.
  3. Radicular distribution of leg pain based on history and correlation with advancing imaging. Radicular pain may be fixed or claudicatory in nature.
  4. Pain resistant to a trial of conservative therapy (i.e. oral steroids, NSAIDs, opioids, muscle relaxants, physical therapy, chiropractic or other non-invasive care) for at least 3 months.
  5. Mild-moderate-severe lumbar foraminal or subarticular zone stenosis, and/or mild-moderate central canal spinal stenosis identified by MRI or CT scan according to radiologic criteria (Boden 1996).
  6. Ability to read English and complete the assessment questionnaires.
  7. Must have been 90 days since last steroid injection.

Exclusion Criteria:

  1. Patients in the opinion of the treating investigator who are unwilling or unable to comply with study procedures.
  2. Systemic infection or local infection over planned injection site.
  3. Bleeding disorder, current use of anticoagulants or anti-platelet medications.
  4. Intrinsic spinal cord lesions.
  5. History of central neurologic, cerebrovascular, demyelinating or muscular disease.
  6. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within the last 6 months).
  7. Allergy to medications being used for injection procedures.
  8. Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.
  9. Cognitive deficit or motor neuron disease.
  10. Spinal instability requiring surgery.
  11. History of spinal fusion surgery
  12. Metastatic cancer.
  13. Concordant pain with internal rotation of the hip (or known hip joint pathology)

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): NCT04537026


Contacts
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Contact: Shellie Cunningham, BS 801-587-5488 shellie.cunningham@hsc.utah.edu
Contact: Maddie Littell 801-587-1436 madelaine.littell@hsc.utah.edu

Locations
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United States, Utah
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Shellie S Cunningham, BS    801-587-5488    shellie.cunningham@hsc.utah.edu   
University of Utah Orthopaedic Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Zachary MCCormick    801-587-5458    Zachary.McCormick@hsc.utah.edu   
Principal Investigator: Zachary McCormick, MD         
Sponsors and Collaborators
University of Utah
Cell Therapy & Regenerative Medicine
SKAGGs Foundation
Investigators
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Principal Investigator: Zachary L McCormick, MD University of Utah
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Responsible Party: Zack McCormick, Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship, University of Utah
ClinicalTrials.gov Identifier: NCT04537026    
Other Study ID Numbers: IRB 131761
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zack McCormick, University of Utah:
Amniotic Fluid
Epidural Injection
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action