Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion

June 9, 2020 updated by: Bone Therapeutics S.A

A Pilot Phase 2a, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) Implantation in Rescue Interbody Fusion

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Anderlecht, Belgium
        • Investigating site BE01
      • Charleroi, Belgium
        • Investigating site BE02
      • Genk, Belgium
        • Investigating site BE04

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLOB® Implantation
Drug: ALLOB®
Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain using a Visual Analogue Scale
Time Frame: 12 months
12 months
Lumbar fusion progression as assessed by CT scan
Time Frame: 12 months
12 months
Functional Disability using Oswestry Disability Index
Time Frame: 12 months
12 months
Global Disease Evaluation using a Visual Analogue Scale
Time Frame: 12 months
12 months
Percentage of patients having a rescue surgery
Time Frame: 12 months
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bone Therapeutics S.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 9, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ALLOB-RIF1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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