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Sterile Amniotic Fluid Filtrate Epidural Injection.

NCT04537026 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-09-24

No results posted yet for this study

Summary

There is a large population of patients with lumbosacral radicular pain due to spinal stenosis who do not respond to physical therapy or oral medication management, yet wish to avoid spinal surgery or are simply not candidates due to medical co-morbidity. Given the natural history of lumbar spinal stenosis, these patients typically suffer from chronic pain and disability. Currently, the typical treatment for this population is serial corticosteroid injection. The efficacy of the treatment specifically for the indication of spinal stenosis is in question and is associated with both concerning chronic sequelae and the risk, although low, of catastrophic neurologic compromise. Alternatively, hAF is a promising new biologic treatment with neuro-protective and regenerative properties. Early studies demonstrate its anti-inflammatory properties, with high levels of anti-inflammatory cytokines, in addition to its ability to assist with regeneration of peripheral nerves. Furthermore, it has a favorable side-effect profile without concern for long-term sequelae or potential for neurologic compromise. The present study aims to determine if epidural injection of hAF compared to the corticosteroid dexamethasone is more effective for the treatment of lumbosacral radicular pain due to spinal stenosis, as measured by pain, disability, psychological function, oral analgesic use, and avoidance of surgery. Evidence for superiority of epidural hAF compared to dexamethasone injection would change the treatment paradigm for refractory radicular pain due to spinal stenosis. Furthermore, even if shown to be non-inferior to epidural dexamethasone, epidural hAF would be favored given its superior safety profile. Thus, this research has the potential to improve outcomes and patient safety in a very large population with chronic pain.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DRUG

Amniotic Fluid Allograft

Amniotic Fluid Allograft will be mixed with sterile water and injected using transforaminal approach

DRUG

Dexamethasone sodium phosphate

Dexamethasone phosphate mixed with sterile water will be injected by transforaminal approach

Sponsors & Collaborators

Principal Investigators

  • Zachary L McCormick, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2025-07-01
Completion
2025-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537026 on ClinicalTrials.gov