drugset / Trial / NCT02932020
AlloGen-LI Treatment of Spinal Stenosis
RandomizedSingle-groupSingle-blindTreatment
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.
Timeline
- Start
- 2016-10
- Primary completion
- 2017-09
- Completion
- 2017-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AlloGen-LI | Other / unclassified | 2 ml | Other |
| Subject | Methylprednisolone | Other / unclassified | 1 ml | Other |
| Background | Bupivacaine | Other / unclassified | 2 ml | Other |
Indications
No indication recorded.