Sterile Amniotic Fluid Filtrate Epidural Injection.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 May 2025
• Main ID: NCT04537026
• Date of registration: 28/08/2020
• Prospective Registration: Yes
• Primary sponsor: University of Utah
• Public title: Sterile Amniotic Fluid Filtrate Epidural Injection.
• Scientific 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: Improving Safety and Outcomes in the Treatment of Pain and Disability Related to Spinal Stenosis.
• Date of first enrolment: June 16, 2021
• Target sample size: 61
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04537026
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Zachary L McCormick, MD
• Affiliation: University of Utah

Key inclusion & exclusion 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)


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lumbar Spinal Stenosis

Intervention(s)

Drug: Dexamethasone sodium phosphate

Drug: Amniotic Fluid Allograft

Primary Outcome(s)

The percentage of participants reporting >50% improvement in NRS pain score at 3 months; back and leg pain separately. [Time Frame: 3 months]

The number of adverse events associated with the drug injection. [Time Frame: 2 years]

Secondary Outcome(s)

Mean change in daily morphine equivalent consumption [Time Frame: 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. [Time Frame: 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 [Time Frame: 3 months]

Mean change in MQS III score. All medications will be entered into the medication quantification Scale III equation, which is used to determine the standardized cumulative detriment related to a particular medication regimen [Time Frame: From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)]

Mean change in Oswestry Disability Index (ODI) score improvement [Time Frame: From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)]

Mean change in the Numeric Pain Rating Scale (NPRS) pain score (back and leg pain separately). [Time Frame: 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 [Time Frame: From the Baseline Visit to Visit 8 (24 months) or after Protocol Version 15, Baseline Visit to Visit 6 (6 months)]

Secondary ID(s)

IRB 131761

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cell Therapy & Regenerative Medicine