A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Rescue Interbody Fusion
Overview
- Phase
- Phase 2
- Intervention
- ALLOB®
- Conditions
- Failed Lumbar Fusion
- Sponsor
- Bone Therapeutics S.A
- Enrollment
- 6
- Locations
- 3
- Primary Endpoint
- Functional Disability using Oswestry Disability Index
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
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
- •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
Arms & Interventions
ALLOB® Implantation
Intervention: ALLOB®
Outcomes
Primary Outcomes
Functional Disability using Oswestry Disability Index
Time Frame: 12 months
Lumbar fusion progression as assessed by CT scan
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
- Pain using a Visual Analogue Scale(12 months)
- Global Disease Evaluation 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)
- Percentage of patients having a rescue surgery(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)