Amniotic Fluid Injection for Spinal Stenosis

Overseen By PMR Research Group

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Utah

Must not be taking: Anticoagulants, Anti-platelet

Disqualifiers: Infections, Bleeding disorders, Neurologic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for lumbosacral radicular pain due to spinal stenosis, characterized by persistent lower back and leg pain unresponsive to regular medications or physical therapy. It compares two treatments: a standard corticosteroid injection and an experimental injection using sterile amniotic fluid filtrate, which may aid in nerve protection and regeneration. Participants should have experienced low back and leg pain for at least three months despite other treatments. The study aims to find a safer and potentially more effective method to manage this chronic pain without surgery. As a Phase 1/Phase 2 trial, it focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the sterile amniotic fluid used in this study is generally safe. Previous studies found no major differences in safety or side effects when comparing amniotic fluid injections to placebos, which are inactive treatments. This indicates that the treatment is usually well-tolerated. The injections also have a favorable side-effect profile, meaning they don't cause long-term problems or issues with the nervous system. Notably, the treatment has anti-inflammatory properties, which can help reduce swelling and pain. Overall, evidence supports the safety of amniotic fluid injections for treating spinal stenosis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for spinal stenosis?

Researchers are excited about the use of amniotic fluid injections for spinal stenosis because it introduces a novel approach by using natural regenerative components. Unlike standard treatments like steroid injections that primarily target inflammation, amniotic fluid is rich in growth factors and anti-inflammatory proteins that may promote healing and regeneration of spinal tissues. This unique mechanism has the potential to not only relieve pain but also improve the underlying condition, offering a promising alternative to current therapies.

What evidence suggests that this trial's treatments could be effective for spinal stenosis?

Research has shown that sterile amniotic fluid may help treat spinal stenosis, a condition causing back pain and disability. In this trial, some participants will receive transforaminal epidural injections of sterile amniotic fluid. Early results suggest these injections can reduce swelling, potentially aiding nerve healing and pain relief. Studies have found that people experience less back and leg pain and improved mobility after these injections. Patients with spinal issues have reported reduced pain and increased ease in performing physical activities. Additionally, amniotic fluid is considered safe, with fewer long-term side effects than traditional treatments like corticosteroids, used in the comparator arm of this trial. ^{1 2 4 6 7}

Who Is on the Research Team?

Zachary McCormick, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sterile Amniotic Fluid Filtrate

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

SKAGGs Foundation

Collaborator

Trials

1

Recruited

110+

Cell Therapy & Regenerative Medicine

Collaborator

Trials

1

Recruited

110+

Published Research Related to This Trial

In a study involving 30 mice with induced dry eye, topical human amniotic fluid (HAF) significantly improved tear production and corneal staining compared to human serum (HS) and artificial tears within 2 weeks.

HAF also preserved goblet cell density better than the control group, suggesting it may be a more effective treatment for dry eye conditions, although further clinical studies are needed to confirm these findings in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of topical human amniotic fluid and human serum in a mouse model of keratoconjunctivitis sicca. Quinto, GG., Camacho, W., Castro-Combs, J., et al.[2018]

Human amniotic fluid (HAF) demonstrated superior keratinocyte survival compared to saline and custodial solutions in preserving full-thickness skin samples, indicating its potential as an effective preservation solution.

The study involved 25 skin samples preserved in various solutions, with HAF showing statistically significant benefits in cell survival over time, suggesting it could be a cost-effective alternative for skin banks and burn centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic fluid for ex vivo skin preservation: a comparative study of tissue preservation solutions. Buseman, J., Rinker, AB., Rinker, B.[2019]

In a study involving five late-gestation fetal sheep, intra-amniotic infusion of either amniotic fluid or lactated Ringer's solution did not result in a significant difference in the retention of infused fluid over 2 days, indicating that both fluids have similar effects on amniotic fluid volume.

The study found that the increase in amniotic fluid volume after infusion was not influenced by the composition of the fluids, suggesting that the presence of hormones or growth factors in amniotic fluid may not be critical for maintaining fluid volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amniotic fluid volume responses to amnio-infusion of amniotic fluid versus lactated Ringer's solution in fetal sheep. Brace, RA., Cheung, CY.[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]

This study successfully isolated and expanded 78 clonal stem cell populations from amniotic fluid samples collected during mid-gestation (15-22 weeks), demonstrating a reliable method for obtaining these cells for potential therapies.

The isolated mesenchymal stem cells were shown to express specific markers and could be differentiated into various cell types, indicating their versatility for future perinatal treatments, as evidenced by their detection in the lungs and hearts of newborn mice after injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine clonal expansion of mesenchymal stem cells derived from amniotic fluid for perinatal applications. Zia, S., Toelen, J., Mori da Cunha, M., et al.[2018]

A phase I/II clinical trial is being designed to evaluate the safety and feasibility of using intravenous human amniotic fluid (hAF) as a treatment for COVID-19, following promising results from a pilot study involving 10 patients.

The primary outcome of the trial will measure changes in C-reactive protein levels, a marker of inflammation, while secondary outcomes will assess safety and various clinical results over 30 days, including mortality and length of hospital stays.

NCBI (Pubmed)

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. Tonna, JE., Pierce, J., Hatton, N., et al.[2021]

In a Phase I/II clinical trial involving 47 hospitalized COVID-19 patients, intravenous administration of acellular human amniotic fluid (hAF) did not show significant improvements in systemic inflammation markers compared to placebo, indicating limited efficacy in this context.

The study found no significant differences in safety outcomes or adverse events between the hAF and placebo groups, suggesting that hAF can be safely administered to patients with COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blinded, placebo-controlled clinical trial of sterile filtered human amniotic fluid for treatment of COVID-19. Tonna, JE., Pierce, J., Brintz, BJ., et al.[2023]

In a study involving 24 female Wistar rats, treatment with whole human amniotic fluid (HAF) did not significantly reduce postoperative adhesions compared to the control group.

However, HAF that was depleted of cells and proteins significantly reduced adhesion formation, fibrosis, and inflammation, indicating its potential as a beneficial treatment in preventing adhesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiadhesive role of human amniotic fluid on peritoneal adhesion formation in a rat model. Experimental study. Hizli, D., Yilmaz, S., Kosus, N., et al.[2013]

Human amniotic fluid (HAF) significantly enhances fracture healing, particularly when collected at 18 weeks of gestation, as shown in a study involving 36 tibial fractures in rats.

The group receiving HAF from the earlier gestation period exhibited the highest healing scores and metabolic activity at the fracture site compared to other groups, indicating that the timing of HAF collection influences its regenerative properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of human amniotic fluid on fracture healing in rat tibia. Kerimoğlu, S., Livaoğlu, M., Sönmez, B., et al.[2009]

In a study involving 32 rabbits, the application of human amniotic fluid (HAF) after tendon repair significantly reduced adhesion formation and improved tendon healing, particularly when combined with sheath repair.

Tendons treated with HAF showed higher tensile strength compared to those without HAF, indicating that HAF application does not hinder healing and may enhance the overall recovery of repaired tendons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of human amniotic fluid on peritendinous adhesion formation and tendon healing after flexor tendon surgery in rabbits. Ozgenel, GY., Samli, B., Ozcan, M.[2013]

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 study of 53 patients with low amniotic fluid (AFI ≤ 5.0 cm), prophylactic saline amnioinfusion did not significantly reduce adverse fetal outcomes compared to a control group, despite increasing the AFI from 3.0 cm to 8.9 cm after treatment.

There were no significant differences in the rates of complications such as fetal heart rate decelerations, need for cesarean sections, or low Apgar scores between the amnioinfused group and the non-infused group, suggesting that amnioinfusion may not provide the expected benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic intrapartum amnioinfusion for patients with oligohydramnios. A prospective randomized study. Chauhan, SP., Rutherford, SE., Hess, LW., et al.[2004]

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AF epidural injections are most effective for patients with lumbar HNP and moderately effective for those with SS.

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withpower.com

withpower.com/trial/phase-2-spinal-stenosis-5-2021-65f51

Amniotic Fluid Injection for Spinal Stenosis

A study on amniotic suspension allograft (ASA) for knee osteoarthritis showed it was safe, with fewer patients reporting unacceptable pain compared to other ...

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midwestspine.net/wp-content/uploads/2024/01/AF-Epidural-Study-PPT-ISASS-2020.pdf

Effectiveness of Amniotic Fluid Injection for Low Back Pain

Stenosis: significant improvement @ all FU, VAS back & leg pain,. Pain Diagram, ODI, PROMIS-Phys. • DDD: significant improvement at @ all FU, VAS back pain.

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pmc.ncbi.nlm.nih.gov

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The Effect of Amniotic Tissue on Spinal Interventions

Amnion products have shown promising effects in reducing epidural adhesions and scar tissue after spine surgery, improving spinal fusion rate and postoperative ...

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Cell-Free Amniotic Fluid and Regenerative Medicine

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Effectiveness of Amnion Allograft Injections in Patients...

Results indicated that amnion allograft injections produced significant pain reduction, functional improvement, and quality of life enhancement in patients ...