Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis (Spine1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03100032|
Recruitment Status : Active, not recruiting
First Posted : April 4, 2017
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spondylolisthesis||Biological: NVD-001 Procedure: Standard of Care||Phase 1 Phase 2|
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 initialfollow-up period post-surgery and a subsequent 12-month 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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)|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Autologous osteogenic cells in ECM with DBM
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.
Active Comparator: Standard of Care
Best standard of care in surgical practice
Procedure: Standard of Care
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally cancellous bone (laminectomy)
- NVD-001 (nocc AEs) [ Time Frame: 12 months ]Number of Adverse Events (AEs) severity, relatedness to the product or procedure, required action and outcome, up to 12 months post-surgery
- NVD-001 (npat AEs) [ Time Frame: 12 months ]Number of participants presenting Adverse Events (AEs).
- NVD-001 (nocc SAEs) [ Time Frame: 24 months ]Number of serious Adverse Events (SAEs), severity, relatedness to the product or procedure, required action and outcome.
- NVD-001 (npatSAEs) [ Time Frame: 24 months ]Number of participants presenting Serious Adverse Events (AEs).
- NVD-001 (nocc AESI) [ Time Frame: 24 months ]Number of Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.
- NVD-001 (npat AESI) [ Time Frame: 24 months ]Number of participants with Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.
- NVD-001 (npat Safety X-rays) [ Time Frame: 24 months ]Number of participants with appearance or absence of calcification/ ossification and ectopic bone formation in comparison with preoperative, as determined by chest X-rays.
- NVD-001 (npat Safety Post-Op) [ Time Frame: 1 month ]Number of participants with occurrence or absence of surgical intervention-related safety parameters such as infection and peri- and post-operative blood loss volume
- NVD-001 (LSF) [ Time Frame: 24 months ]Lumbar Spine Fusion progression and non-fusion assessed by serial CT-Scans images of lumbar spine post-surgery and lumbar spine static and dynamic radiographic images.
- NVD-001 (ODI) [ Time Frame: 24 months ]Functional disability by means of Oswestry Disability Index (ODI).
- NVD-001 (BPI) [ Time Frame: 24 months ]Pain by means of Brief Pain Inventory (BPI).
- NVD-001 (OTE) [ Time Frame: 24 months ]Overall treatment effect using OTE scale.
- NVD-001 (QoL) [ Time Frame: 24 months ]Quality of life (QoL) by means of patient's questionnaire EuroQoL 5 Dimensions post-surgery.
- NVD-001 (timeSurgery) [ Time Frame: 1 day ]Surgical duration.
- NVD-001 (stayPostOp) [ Time Frame: 7 days ]Duration of postoperative hospital stay.
- NVD-001 (subsequentSurgery) [ Time Frame: 24 months ]Description of subsequent surgical interventions (revision, removal, reoperation and supplemental fixation).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100032
|Saint-Luc University Hospital|
|Brussels, Belgium, 1200|
|Centre Hosp. Univ. UCL - Namur site Godinne - Service de neurochirurgie|
|Yvoir, Belgium, 5530|
|Fakultní nemocnice Brno|
|Brno, Czechia, 625 00|
|Fakultní nemocnice v Motole|
|Praha 5, Czechia, 150 06|
|Uniwersyteckie Centrum Kliniczne|
|Gdańsk, Poland, 80-952|
|Centrum Medyczne Angelius Provita|
|Katowice, Poland, 40-611|
|Szpital Św. Rafała|
|Kraków, Poland, 30-693|
|Study Director:||Béatrice De Vos, MD, PhD||Novadip Biosciences|
|Principal Investigator:||Christian Raftopoulos, MD, PhD||Saint-Luc University Hospital, Department of Neurosurgery|