Here are five observations:
1. This is the first trial in which a bone cell therapy product is placed percutaneously directly into the failed fusion area without an open procedure.
2. The product, called ALLOB, is designed to promote the fusion process though stimulation of bone formation.
3. The trial is a proof-of-concept Phase IIA, designed to test the safety of the ALLOB implantation in rescue spinal fusion over 12 months.
4. Sixteen patients with failed lumbar spinal fusions at 15 months or more after surgery will be treated with a single implantation.
5. Fluoroscopy helps with the visualization of the exact location of implant placement. CT-scans will evaluate the efficacy.
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