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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Drug: ALLOB® cells with ceramic scaffold

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Investigating site BE01
  • Brussels, Belgium
    • Investigating site BE03
  • Brussels, Belgium
    • Investigating site BE05
  • Charleroi, Belgium
    • Investigating site BE02
  • Genk, Belgium
    • Investigating site BE04
  • Kortrijk, Belgium
    • Investigating site BE08
  • Liège, Belgium
    • Investigating site BE07
  • Mons, Belgium
    • Investigating site BE06

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALLOB® cells with ceramic scaffold; ALLOB® cells with ceramic scaffold Implantation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Lumbar fusion progression as assessed by CT scan	12 months
Functional Disability using Oswestry Disability Index	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain using a Visual Analogue Scale	12 months
Lumbar fusion progression as assessed by CT scan	12 months
Functional Disability using Oswestry Disability Index	12 months
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

Collaborators and Investigators

• Sponsor: Bone Therapeutics S.A

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Cell Therapy; Degenerative Disc Disease; Bone Graft; Spinal Fusion; Lumbar Interbody Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: ALLOB-IF1