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
Overview
- Phase
- Phase 2
- Intervention
- ALLOB® cells with ceramic scaffold
- Conditions
- Degenerative Disc Disease
- Sponsor
- Bone Therapeutics S.A
- Enrollment
- 38
- Locations
- 8
- Primary Endpoint
- Lumbar fusion progression as assessed by CT scan
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
ALLOB® cells with ceramic scaffold
ALLOB® cells with ceramic scaffold Implantation
Intervention: ALLOB® cells with ceramic scaffold
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Percentage of patients having a rescue surgery(12 months)
- Global Disease Evaluation using a Visual Analogue Scale(12 months)
- Potential occurrence of any AE or SAE related to the product or to the procedure(36 months)
- Pain using a Visual Analogue Scale(12 months)
- Functional Disability using Oswestry Disability Index(12 months)
- Lumbar fusion progression as assessed by CT scan(12 months)