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 : November 28, 2022
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Condition or disease | Intervention/treatment | Phase |
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Lumbar Spinal Stenosis | Drug: Amniotic Fluid Allograft Drug: Dexamethasone sodium phosphate | Phase 1 Phase 2 |

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 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: Dexamethasone sodium phosphate
Dexamethasone phosphate mixed with sterile water will be injected by transforaminal approach |
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who are ≥ 18 years old
- Pain in the low back and lower extremity (pain NRS >4) with buttock/leg pain > back pain.
- Radicular distribution of leg pain based on history and correlation with advancing imaging. Radicular pain may be fixed or claudicatory in nature.
- 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.
- 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).
- Ability to read English and complete the assessment questionnaires.
- Must have been 90 days since last steroid injection.
Exclusion Criteria:
- Patients in the opinion of the treating investigator who are unwilling or unable to comply with study procedures.
- Systemic infection or local infection over planned injection site.
- Bleeding disorder, current use of anticoagulants or anti-platelet medications.
- Intrinsic spinal cord lesions.
- History of central neurologic, cerebrovascular, demyelinating or muscular disease.
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within the last 6 months).
- Allergy to medications being used for injection procedures.
- 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.
- Cognitive deficit or motor neuron disease.
- Spinal instability requiring surgery.
- History of spinal fusion surgery
- Metastatic cancer.
- Concordant pain with internal rotation of the hip (or known hip joint pathology)

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
Contact: PMR Research Group | 801-587-5432 | PMR.Research@hsc.utah.edu | |
Contact: Maddie Littell | 801-587-1436 | madelaine.littell@hsc.utah.edu |
United States, Utah | |
University of Utah Orthopaedic Center | Recruiting |
Salt Lake City, Utah, United States, 84108 | |
Contact: PMR Research Group 801-587-5432 PMR.Research@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 |
Principal Investigator: | Zachary L McCormick, MD | University of Utah |
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: | November 28, 2022 |
Last Verified: | November 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Amniotic Fluid Epidural Injection |
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 |