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

Phase 2

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Drug: ALLOB® cells with ceramic scaffold

• Registration Number: NCT02205138
• Lead Sponsor: Bone Therapeutics S.A

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Study Start: 2014-10
• Primary Completion: 2019-02
• Status Verified: 2021-01
• Study Completion: 2021-01-25
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLOB® cells with ceramic scaffold	ALLOB® cells with ceramic scaffold	ALLOB® cells with ceramic scaffold Implantation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Global Disease Evaluation using a Visual Analogue Scale	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
Pain 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

Trial Locations

Locations (8)

Investigating site BE03; 🇧🇪 Brussels, Belgium

Investigating site BE04; 🇧🇪 Genk, Belgium

Investigating site BE08; 🇧🇪 Kortrijk, Belgium

Investigating site BE07; 🇧🇪 Liège, Belgium

Investigating site BE06; 🇧🇪 Mons, Belgium

Investigating site BE01; 🇧🇪 Brussels, Belgium

Investigating site BE05; 🇧🇪 Brussels, Belgium

Investigating site BE02; 🇧🇪 Charleroi, Belgium