The SAFE Trial. Sterile Amniotic Fluid Filtrate Epidural Injection.
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Utah
Collaborators:
Cell Therapy & Regenerative Medicine SKAGGs Foundation