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Amniotic Fluid Injection for Spinal Stenosis

Phase 1 & 2
Recruiting
Led By Zachary L McCormick, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pain in the low back and lower extremity (pain NRS >4) with buttock/leg pain > back pain.
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new treatment, hAF, for lumbosacral radicular pain due to spinal stenosis, to see if it is more effective than the current treatment, dexamethasone injection.

Who is the study for?
This trial is for adults over 18 with chronic leg pain due to lumbar spinal stenosis, who haven't improved after at least 3 months of non-invasive treatments like physical therapy or medication. They must be able to read English and complete questionnaires, have not had a steroid injection in the past 90 days, and can't join if they're pregnant, have allergies to the injections used, bleeding disorders, recent heart attacks, history of certain neurological diseases or spinal surgeries.Check my eligibility
What is being tested?
The study compares two treatments for chronic back-related leg pain: an epidural injection of amniotic fluid allograft (hAF), which has regenerative properties and may reduce inflammation without severe side effects; versus dexamethasone sodium phosphate (a corticosteroid). The goal is to see which treatment better reduces pain and disability without leading to surgery.See study design
What are the potential side effects?
Dexamethasone might cause issues like increased blood sugar levels or risk of infection. Amniotic Fluid Allograft is expected to have fewer side effects but could potentially include mild reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe lower back and leg pain, with the leg pain being worse than the back pain.
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My scans show I have a narrowing in my lower back's spinal canal.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The number of adverse events associated with the drug injection.
The percentage of participants reporting >30% improvement in SSSQ score at 6 weeks.
The percentage of participants reporting >50% improvement in NRS pain score at 6 weeks; back and leg pain separately.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transforaminal epidural Amniotic Fluid injectionExperimental Treatment1 Intervention
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.
Group II: Transforaminal epidural dexamethasone injectionActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

SKAGGs FoundationUNKNOWN
University of UtahLead Sponsor
1,104 Previous Clinical Trials
1,782,421 Total Patients Enrolled
Cell Therapy & Regenerative MedicineUNKNOWN

Media Library

Sterile Amniotic Fluid Filtrate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04537026 — Phase 1 & 2
Lumbar Spinal Stenosis Research Study Groups: Transforaminal epidural dexamethasone injection, Transforaminal epidural Amniotic Fluid injection
Lumbar Spinal Stenosis Clinical Trial 2023: Sterile Amniotic Fluid Filtrate Highlights & Side Effects. Trial Name: NCT04537026 — Phase 1 & 2
Sterile Amniotic Fluid Filtrate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04537026 — Phase 1 & 2
Lumbar Spinal Stenosis Patient Testimony for trial: Trial Name: NCT04537026 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical purposes is Amniotic Fluid Allograft often employed?

"Amniotic Fluid Allograft is a medical treatment used to ameliorate ophthalmia, sympathetic. It has also shown efficacy in treating other conditions such as branch retinal vein occlusion and macular edema."

Answered by AI

How many subjects are included in this clinical investigation?

"That is correct. As of December 9th, 2021, the study detailed on clinicaltrials.gov is still looking for 112 participants across 1 location."

Answered by AI

Does this clinical trial have open enrollment at the moment?

"Yes, this clinical trial is still open and actively recruiting participants. The listing was first posted on June 16th, 2021 and the 12/9/2021 update indicates that they are still looking for candidates."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
University of Utah Orthopaedic Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have tried medications, electronic stimulator implant, steroid shots and am still in excruciating pain.
PatientReceived 1 prior treatment
~18 spots leftby Jan 2025