Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion

Study Overview
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Brief Summary
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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.

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 Lumbar Spinal Fusion

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Drug: ALLOB® cells with ceramic scaffold


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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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® cells with ceramic scaffold<br>ALLOB® cells with ceramic scaffold Implantation | Drug: ALLOB® cells with ceramic scaffold<br>* Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia<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 |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Fusion, Lumbar Interbody Fusion, Degenerative Disc Disease, Cell Therapy, Bone Graft