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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
Investigating site BE01
Brussels, Belgium
Investigating site BE03
Brussels, Belgium
Investigating site BE05
Brussels, Belgium
Investigating site BE02
Charleroi, Belgium
Lumbar fusion progression as assessed by CT scan
Time frame: 12 months
Functional Disability using Oswestry Disability Index
Time frame: 12 months
Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements
Time frame: 12 months
Pain using a Visual Analogue Scale
Time frame: 12 months
Global Disease Evaluation using a Visual Analogue Scale
Time frame: 12 months
Functional Disability using Oswestry Disability Index
Time frame: 12 months
Lumbar fusion progression as assessed by CT scan
Time frame: 12 months
Percentage of patients having a rescue surgery
Time frame: 12 months
Potential occurrence of any AE or SAE related to the product or to the procedure
Time frame: 36 months
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Investigating site BE04
Genk, Belgium
Investigating site BE08
Kortrijk, Belgium
Investigating site BE07
Liège, Belgium
Investigating site BE06
Mons, Belgium