Pilot Study Investigating the Utility of Epidural AlloGen-LI Injection for Treatment of Spinal Stenosis Symptoms
Description
Brief Summary
In this pilot study, investigators will test the efficacy of AlloGen-LI, an allograft
derived from amniotic fluid, injected into the epidural space at the level of spinal
stenosis as an anti-inflammatory treatment to relieve back and leg pain symptoms in patients
with spinal stenosis and/or disc herniation. The patients will be followed for 12 weeks. The
effect of this treatment will be examined by patient reported changes in pain and disability
utilizing validated outcome measures, and MRI imaging evaluating changes in contrast
enhancement and T2 signal related to that reflect inflammation and degeneration.
Detailed Description
AlloGen-LI contains multiple factors that may serve to ameliorate the detrimental effects of
osteorarthritis and degenerative disc disease. Anti-inflammatory components include
inhibitors of matrix metalloproteins and pro-inflammatory cytokines, growth factors and
interleukins. The product has low immunogenicity and is hypo-osmotic.2 Placental tissues,
including amniotic fluid, amniotic membrane and chorion are regulated as human cell and
tissue products (HCTP) by the FDA. This regulation allows clinicians to use the allograft
materials for human injection. AlloGen-LI is derived from placental tissues obtained from
carefully screened healthy mothers at the time of scheduled cesarean section. The mothers
have agreed to donate the tissues, which would otherwise be discarded. The experimental
treatment would entail an injection of one dose of AlloGen-LI and marcaine into the epidural
space under CT guidance, in an identical manner to traditional epidural steroid /marcaine
injections.
Phase
OtherInclusion and Exclusion Criteria
- Low back pain of > 4-5 weeks but < 6-7 months
- Evidence of at least mild lumbar stenosis /disc herniation on MRI
- Failure of conservative therapy to include physical therapy and pharmacotherapy
- Patient is at least 18 years of age
- Patient is willing to be blinded to treatment until after the 12 week post injection visit
- Patient is willing and able to review and sign the study informed consent form
- Patient has had prior
- Patient has received epidural steroid injection in the past
- Patient currently receives systemic steroids for another medical condition 5.
- Patient has systemic infection at the proposed injection site 7.
- Current therapy with any immunosuppressive medication
- History of solid organ or hematologic transplantation 10 History of autoimmune disorder
- Devices and conditions that are contraindications for MRI examination (routinely screened before all MRI examinations).
- Patient has eGFR of <40
- Patient has known chronic kidney disease
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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