Amniotic Fluid Injection for Spinal Stenosis

Recruiting in Palo Alto (17 mi)

Overseen by Zachary McCormick, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Utah

Must not be taking: Anticoagulants, Anti-platelet

Disqualifiers: Infections, Bleeding disorders, Neurologic diseases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment using fluid from around a baby in the womb to help people with chronic back pain who haven't found relief from other treatments. The fluid reduces inflammation and helps repair nerves, which can ease pain and improve daily function.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you must have been off steroid injections for at least 90 days before joining.

What data supports the effectiveness of the treatment Sterile Amniotic Fluid Filtrate for spinal stenosis?

Research shows that human amniotic fluid, which contains growth factors, has been effective in promoting healing in various tissues, such as tendons and bones, in animal studies. This suggests it might help with tissue repair in conditions like spinal stenosis. ^{1 2 3 4 5}

Is amniotic fluid injection safe for humans?

A study on amniotic suspension allograft (ASA) for knee osteoarthritis showed it was safe, with fewer patients reporting unacceptable pain compared to other treatments. This suggests that amniotic fluid injections may be generally safe in humans. ^{2 6 7 8 9}

How is the amniotic fluid injection treatment for spinal stenosis different from other treatments?

The amniotic fluid injection treatment is unique because it uses sterile amniotic fluid filtrate, which has anti-inflammatory properties and has been safely used in various conditions. Unlike traditional treatments, this approach leverages the natural healing components found in amniotic fluid, potentially offering a novel way to reduce inflammation associated with spinal stenosis. ^{3 6 10 11 12}

Research Team

Zachary McCormick, MD

Principal Investigator

University of Utah

Eligibility Criteria

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.

Inclusion Criteria

My pain hasn't improved after 3 months of standard treatments.

I have severe lower back and leg pain, with the leg pain being worse than the back pain.

It has been over 90 days since my last steroid injection.

Exclusion Criteria

I am allergic to the medications used in injection procedures.

I have had spinal fusion surgery.

I experience pain when rotating my hip inward.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either transforaminal epidural dexamethasone injection or transforaminal epidural amniotic fluid injection

6 weeks

Multiple visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular follow-up visits

Treatment Details

Interventions

• Sterile Amniotic Fluid Filtrate (Other)

Trial Overview 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.

Participant Groups

Group I: Transforaminal epidural Amniotic Fluid injection Experimental Treatment 1 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 injection Active Control 1 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 Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Orthopaedic Center Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1169

Recruited

1,623,000+

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

SKAGGs Foundation

Collaborator

Trials

1

Recruited

110+

Cell Therapy & Regenerative Medicine

Collaborator

Trials

1

Recruited

110+

Findings from Research

Human platelet-derived growth factors can effectively replace bovine serum in the culture of human amniotic fluid stem cells (hAFSC) without compromising cell proliferation, differentiation, or safety, as shown in a study comparing both culture methods.

The use of human platelet lysate for expanding hAFSC resulted in no cytogenetic abnormalities and demonstrated no tumorigenicity in both in vitro and in vivo studies, suggesting it is a safer alternative for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A humanized system to expand in vitro amniotic fluid-derived stem cells intended for clinical application. Martinelli, D., Pereira, RC., Mogni, M., et al.[2018]

In a multicenter randomized controlled trial involving 200 subjects with knee osteoarthritis, amniotic suspension allograft (ASA) treatment resulted in significantly greater improvements in pain and function compared to both hyaluronic acid (HA) and saline treatments over 3 and 6 months.

Only 13.2% of patients receiving ASA reported unacceptable pain at 3 months, compared to 68.8% in the HA group and 75% in the saline group, indicating ASA's potential as an effective nonoperative management option for symptomatic knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. Farr, J., Gomoll, AH., Yanke, AB., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of human amniotic fluid on fracture healing in rat tibia. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Antiadhesive role of human amniotic fluid on peritoneal adhesion formation in a rat model. Experimental study. [2013]

3. England pubmed.ncbi.nlm.nih.gov

A humanized system to expand in vitro amniotic fluid-derived stem cells intended for clinical application. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Routine clonal expansion of mesenchymal stem cells derived from amniotic fluid for perinatal applications. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of human amniotic fluid on peritendinous adhesion formation and tendon healing after flexor tendon surgery in rabbits. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Amniotic fluid for ex vivo skin preservation: a comparative study of tissue preservation solutions. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Prophylactic intrapartum amnioinfusion for patients with oligohydramnios. A prospective randomized study. [2004]

8. United States pubmed.ncbi.nlm.nih.gov

Amniotic fluid volume responses to amnio-infusion of amniotic fluid versus lactated Ringer's solution in fetal sheep. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Safety and feasibility of using acellular sterile filtered amniotic fluid as a treatment for patients with COVID-19: protocol for a randomised, double-blinded, placebo-controlled clinical trial. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blinded, placebo-controlled clinical trial of sterile filtered human amniotic fluid for treatment of COVID-19. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Effects of topical human amniotic fluid and human serum in a mouse model of keratoconjunctivitis sicca. [2018]