Degenerative Disc Disease
Conditions
Keywords
Spinal Fusion, Lumbar Interbody Fusion, Degenerative Disc Disease, Cell Therapy, Bone Graft
Brief summary
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.
Interventions
DRUGALLOB® cells with ceramic scaffold
Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
Sponsors
Bone Therapeutics S.A
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lumbar fusion progression as assessed by CT scan | 12 months |
| Functional Disability using Oswestry Disability Index | 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 | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Lumbar fusion progression as assessed by CT scan | 12 months |
| Pain using a Visual Analogue Scale | 12 months |
| Potential occurrence of any AE or SAE related to the product or to the procedure | 36 months |
| Percentage of patients having a rescue surgery | 12 months |
| Global Disease Evaluation using a Visual Analogue Scale | 12 months |
| Functional Disability using Oswestry Disability Index | 12 months |
Countries
Belgium
Outcome results
None listed