Sterile Amniotic Fluid Filtrate Epidural Injection.

NCT04537026 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB 131761
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Amniotic Fluid; Epidural Injection

Outcome Measures

Primary Outcomes (2)

• The number of adverse events associated with the drug injection.

  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 years

• The percentage of participants reporting >50% improvement in NRS pain score at 3 months; back and leg pain separately.

  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 months

Secondary Outcomes (7)

• Mean change in the Numeric Pain Rating Scale (NPRS) pain score (back and leg pain separately).

  From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)

• The percentage of participants reporting >30% improvement on the ODI at 3 months

  3 months

• Mean change in Oswestry Disability Index (ODI) score improvement

  From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)

• The percentage of participants reporting >30% improvement in the Swiss Spinal Stenosis Questionnaire (SSSQ) score.

  From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)

• Mean change in SSSQ score

  From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)

Study Arms (2)

Transforaminal epidural Amniotic Fluid injection

EXPERIMENTAL

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

Transforaminal epidural dexamethasone injection

ACTIVE COMPARATOR

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

Interventions

Amniotic Fluid Allograft DRUG

Amniotic Fluid Allograft will be mixed with sterile water and injected using transforaminal approach

Transforaminal epidural Amniotic Fluid injection

Dexamethasone sodium phosphate DRUG

Dexamethasone phosphate mixed with sterile water will be injected by transforaminal approach

Transforaminal epidural dexamethasone injection

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Utah: lead
• Cell Therapy & Regenerative Medicine: collaborator

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Zachary L McCormick, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: June 16, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)