Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion

A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Lumbar Spinal Fusion

Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. However, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon.

The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.

Inclusion Criteria:

• Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
• Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)
• Unresponsive to non-operative treatment for at least 6 months

Exclusion Criteria:

• Lumbar disc disease requiring treatment at more than one level
• Previous failed fusion at the involved lumbar level
• Local active or latent infection at the involved lumbar level
• Positive serology for hepatitis B, hepatitis C, HIV
• Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator