Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Failed Lumbar Fusion

Intervention / Treatment
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* Drug: ALLOB®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALLOB® Implantation<br> | Drug: ALLOB®<br>* Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Fusion, Revision Surgery, Pseudarthrosis, Cell Therapy, Bone Graft