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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205138
• Other study ID #: ALLOB-IF1
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: January 25, 2021

Study information

• Verified date: January 2021
• Source: Bone Therapeutics S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 25, 2021
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Drug:
• ALLOB® cells with ceramic scaffold
Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia

Locations

Country	Name	City	State
Belgium	Investigating site BE01	Brussels
Belgium	Investigating site BE03	Brussels
Belgium	Investigating site BE05	Brussels
Belgium	Investigating site BE02	Charleroi
Belgium	Investigating site BE04	Genk
Belgium	Investigating site BE08	Kortrijk
Belgium	Investigating site BE07	Liège
Belgium	Investigating site BE06	Mons

Sponsors (1)

Lead Sponsor	Collaborator
Bone Therapeutics S.A

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar fusion progression as assessed by CT scan		12 months
Primary	Functional Disability using Oswestry Disability Index		12 months
Primary	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	Pain using a Visual Analogue Scale		12 months
Secondary	Global Disease Evaluation using a Visual Analogue Scale		12 months
Secondary	Functional Disability using Oswestry Disability Index		12 months
Secondary	Lumbar fusion progression as assessed by CT scan		12 months
Secondary	Percentage of patients having a rescue surgery		12 months
Secondary	Potential occurrence of any AE or SAE related to the product or to the procedure		36 months