Failed Lumbar Fusion
Conditions
Keywords
Spinal Fusion, Revision Surgery, Pseudarthrosis, Cell Therapy, Bone Graft
Brief summary
Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon. Moreover, revision surgeries are unfortunately associated with higher procedure-related complication rates, technical difficulties, longer operative time, and quite disappointing and unreliable success rates for both fusion and clinical results. The present Phase 2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in rescue interbody fusion.
Interventions
DRUGALLOB®
Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.
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 No maximum
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 * Failed lumbar fusion of 15 months minimum requiring a revision surgery at one or two levels between L1 and S1
Exclusion criteria
* More than two failed interbody fusions at the involved lumbar level(s) * Instrumentation failure requiring revision surgery * Local active or latent infection at the involved lumbar level(s) * 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, using patient open non-directive questionnaire, physical examination and laboratory measurements | 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