What side effects are associated with this type of intervention?

Common treatments for Lumbar Spinal Stenosis, such as corticosteroid injections, are associated with side effects including potential chronic sequelae and a low risk of catastrophic neurologic compromise. These treatments may also lead to increased pain, dizziness, fatigue, and visual disturbances. In contrast, investigational treatments like hAF, which have neuro-protective and regenerative properties with anti-inflammatory effects, show promise with a favorable side-effect profile and no long-term sequelae or potential for neurologic compromise.

What prior FDA approvals exist?

Currently, the typical treatment for lumbar spinal stenosis includes serial corticosteroid injections, which are commonly used but have questionable efficacy and potential risks. There is no specific mention of prior FDA approvals for treatments with neuro-protective and regenerative properties similar to hAF in the provided context. However, hAF is being studied for its promising anti-inflammatory effects and potential to assist in peripheral nerve regeneration, which could represent a significant advancement in the treatment paradigm for lumbar spinal stenosis.

What other types of research exist?

Promising novel alternatives to hAF for Lumbar Spinal Stenosis patients include: 1) VEGF (Vascular Endothelial Growth Factor) delivery, which has shown neuro-protective and regenerative properties in ALS models. 2) BDNF (Brain-Derived Neurotrophic Factor) delivery, which has demonstrated improvements in nerve regeneration and function in spinal cord injury models. Both treatments have potential for anti-inflammatory effects and nerve regeneration, making them viable alternatives to hAF.

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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).

Must not have

Allergy to medications being used for injection procedures.

History of spinal fusion surgery.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to the medications used in injection procedures.

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I have had spinal fusion surgery.

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I experience pain when rotating my hip inward.

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I do not have severe heart or lung disease that limits my walking.

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I have a bleeding disorder or am currently on blood thinners.

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I do not have any infections, especially near where I might get an injection.

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I have a history of brain, nerve, or muscle diseases.

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I have a tumor inside my spinal cord.

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My cancer has spread to other parts of my body.

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I need surgery for my unstable spine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lumbar Spinal Stenosis often focus on reducing inflammation, protecting nerve tissues, and promoting regeneration. Corticosteroid injections, for example, work by reducing inflammation around the spinal nerves, thereby decreasing pain and swelling. The investigational treatment hAF (human Amniotic Fluid) offers neuro-protective and regenerative properties, with high levels of anti-inflammatory cytokines that help reduce inflammation and support nerve regeneration. These mechanisms are crucial for patients as they aim to alleviate pain, improve function, and potentially avoid surgical interventions.