Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

Phase 2

Terminated

• Conditions: Failed Lumbar Fusion
• Interventions: Drug: ALLOB®

• Registration Number: NCT02328287
• Lead Sponsor: Bone Therapeutics S.A

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Primary Completion: 2018-04
• Study Completion: 2020-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-09
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLOB® Implantation	ALLOB®	-

Primary Outcome Measures

Name	Time	Method
Functional Disability using Oswestry Disability Index	12 months
Lumbar fusion progression as assessed by CT scan	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

Name	Time	Method
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

Trial Locations

Locations (3)

Investigating site BE02; 🇧🇪 Charleroi, Belgium

Investigating site BE04; 🇧🇪 Genk, Belgium

Investigating site BE01; 🇧🇪 Anderlecht, Belgium