Last updated on June 2018

Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis


Brief description of study

A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 - S1).

Detailed Study Description

This is a prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion of one vertebral segment (L1-S1). The study consists of a 12-month active follow-up period post-surgery and a subsequent 12-month passive long term follow-up.

NVD-001 is an autologous cellular medicinal product obtained by culture of adipose tissue (liposuction) leading to osteogenic cells after ex vivo isolation, expansion and differentiation of pluripotent adipose-tissue stem cells (ASC), and combination with an allogeneic fully demineralised bone matrix into a 3D bone implant.

Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1) who sign informed consent and are eligible will be randomised either to the experimental group (surgical intervention for spinal lumbar interbody fusion with NVD-001) or to the control group (commonly used surgical intervention for spinal lumbar interbody fusion (TLIF, PLIF, minimally invasive or open approach) with one or two PEEK cage(s) filled and surrounded by locally harvested autologous cancellous bone (laminectomy).

Clinical Study Identifier: NCT03100032

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Olivier De Witte, Prof MD ...

H pital Erasme - Neurosurgery Department
Brussels, Belgium
5.97miles
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Christian Raftopoulos, MD, PhD

Saint-Luc University Hospital
Brussels, Belgium
7.84miles
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David van Schaik, MD

Universitair ziekenhuis Brussel - Brussels Health Campus - Department of Orthopaedics and Traumatology
Brussels, Belgium
8.97miles
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Recruitment Status: Open


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