Skip to main content
OpenTrials
Completed

NCT Number: NCT02205138

Phase 2a Study on Allogeneic Osteoblastic Cells 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigating site BE01, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALLOB® cells with ceramic scaffold

Drug

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

Primary outcomes

  1. Lumbar fusion progression as assessed by CT scan

    Time frame: 12 months

  2. Functional Disability using Oswestry Disability Index

    Time frame: 12 months

  3. 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

Secondary outcomes

  1. Pain using a Visual Analogue Scale

    Time frame: 12 months

  2. Global Disease Evaluation using a Visual Analogue Scale

    Time frame: 12 months

  3. Functional Disability using Oswestry Disability Index

    Time frame: 12 months

  4. Lumbar fusion progression as assessed by CT scan

    Time frame: 12 months

  5. Percentage of patients having a rescue surgery

    Time frame: 12 months

  6. Potential occurrence of any AE or SAE related to the product or to the procedure

    Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Bone Therapeutics S.A

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Jul 31, 2014
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.