Spondylolisthesis
Conditions
Keywords
Spinal Fusion, Lumbar Interbody Fusion, Autologous Stem Cell Therapy, Bone Graft, Demineralized Bone Matrix, Polyetheretherketone (PEEK) cage
Brief summary
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 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 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).
Interventions
BIOLOGICALNVD-001
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.
PROCEDUREStandard of Care
At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally cancellous bone (laminectomy)
Sponsors
Novadip Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any subject meeting all of the following inclusion criteria and verified by the Investigator during the screening period: * Subject has understood and accepted to participate in the study according to all study procedures by signing the approved informed consent. * Male or female subjects aged \>18 and is skeletally mature (epiphyses closed). * Subject has clinically important pain or neurological symptoms with or without claudication due to symptomatic degenerative spondylolisthesis grade I or II (Meyerding Classification). * Conservative treatment of disease has failed for at least 3 months since diagnosis. (ISASS 2011) * Subject has a preoperative ODI score \>30. * Subject has an indication for spinal fusion of one vertebral segment (L1-S1) due to symptomatic degenerative spondylolisthesis grade I or II diagnosed by computed tomography (CT) scan and/or magnetic resonance imaging (MRI) and/or dynamic radiography. * Subject is suitable for surgical operation and incorporation of the PEEK cage(s) by transforaminal lumbar interbody fusion (TLIF) or posterior lumbar intervertebral fusion (PLIF) by minimally invasive or open approach in one mobile segment (L1- S1) with bilateral rigid fixation. No posterolateral lumbar fusion (PLF) technique is allowed. * Subject is, in the Investigator's opinion, psychosocially, mentally and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits. * At screening, local laboratory safety test results are clinically acceptable and serology results for HIV, HBV, HCV, HTLV I/II and syphilis are in accordance with country specific requirements for donation of Human Body Material. At time of adipose tissue collection, central laboratory serology and molecular test panel for HIV, HBV, HCV, HTLV I/II and syphilis must be in accordance with Belgian specific requirements for release of Human Body Material. * Women of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year prior to surgery have to have a negative pregnancy test. Results have to be available and negative for the patient to be entered in the study. * WOCBP have to use an effective method of birth control 2 months prior to study entry or to surgical intervention date and throughout the study duration (defined as a method which results in a failure rate of less than 1% per year) such as: * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomised partner (provided that partner is the sole sexual partner of the trial participant and that the surgical success of vasectomy has been confirmed) * Sexual abstinence For each case of delayed menstrual period, confirmation of absence of pregnancy is strongly recommended. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycles. In case a urine pregnancy test is positive, a confirmatory blood pregnancy test is obligatory.
Exclusion criteria
Any subject meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NVD-001 (npat Safety Post-Op) | 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 (nocc AEs) | 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) | 12 months | Number of participants presenting Adverse Events (AEs). |
| NVD-001 (nocc SAEs) | 24 months | Number of serious Adverse Events (SAEs), severity, relatedness to the product or procedure, required action and outcome. |
| NVD-001 (npatSAEs) | 24 months | Number of participants presenting Serious Adverse Events (AEs). |
| NVD-001 (nocc AESI) | 24 months | Number of Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images. |
| NVD-001 (npat AESI) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NVD-001 (LSF) | 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) | 24 months | Functional disability by means of Oswestry Disability Index (ODI). |
| NVD-001 (BPI) | 24 months | Pain by means of Brief Pain Inventory (BPI). |
| NVD-001 (OTE) | 24 months | Overall treatment effect using OTE scale. |
| NVD-001 (QoL) | 24 months | Quality of life (QoL) by means of patient's questionnaire EuroQoL 5 Dimensions post-surgery. |
| NVD-001 (timeSurgery) | 1 day | Surgical duration. |
| NVD-001 (stayPostOp) | 7 days | Duration of postoperative hospital stay. |
| NVD-001 (subsequentSurgery) | 24 months | Description of subsequent surgical interventions (revision, removal, reoperation and supplemental fixation). |
Countries
Belgium, Czechia, Poland
Outcome results
None listed