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NCT04537026 · ClinicalTrials.gov registry record · Phase 1
Sterile Amniotic Fluid Filtrate Epidural Injection.
A Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT04537026: Completed Phase 1 study, sponsored by University of Utah.
NCT04537026 is a Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04537026, a Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
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.
Primary Outcome
Categorical measures of both pain and function will be used for the primary outcome analysis given recent recommendations by the National Institute of Health.
Interventions
- DRUG Dexamethasone sodium phosphate
- DRUG Amniotic Fluid Allograft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-06-16 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 1 |
What the finished NCT04537026 record still lists
NCT04537026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone sodium phosphate is the first listed.
NCT04537026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04537026 about?
NCT04537026 is a clinical study titled "Sterile Amniotic Fluid Filtrate Epidural Injection.". 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 s...
What is the current status of trial NCT04537026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2021-06-16. Estimated completion is 2025-07-01.
What interventions are being tested in trial NCT04537026?
The interventions under investigation include: Dexamethasone sodium phosphate (DRUG), Amniotic Fluid Allograft (DRUG).
Who is sponsoring clinical trial NCT04537026?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04537026's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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