Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

Phase 2TerminatedNCT02328287

Bone Therapeutics S.A6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Failed Lumbar Fusion

Interventions

ALLOB®DRUG

Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Investigating site BE01

Anderlecht, Belgium

Investigating site BE02

Charleroi, Belgium

Investigating site BE04

Genk, Belgium

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

Pain using a Visual Analogue Scale

Time frame: 12 months

Global Disease Evaluation using a Visual Analogue Scale

Time frame: 12 months

Functional Disability using Oswestry Disability Index

Time frame: 12 months

Lumbar fusion progression as assessed by CT scan

Time frame: 12 months

Percentage of patients having a rescue surgery

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: 36 months

Data from ClinicalTrials.gov

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