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)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Spondylolisthesis
- Sponsor
- Novadip Biosciences
- Enrollment
- 48
- Locations
- 12
- Primary Endpoint
- NVD-001 (nocc AEs)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility Criteria
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 \>
- •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.
Exclusion Criteria
- •Any subject meeting any of the following exclusion criteria verified by the Investigator during the screening period will be excluded from enrolment into the study.
- •Subject has known history of hypersensitivity or anaphylactic reaction to PEEK.
- •Due to medical or other reasons spine fusion cannot be delayed for up to 6 months.
- •Indications for spinal fusion other than symptomatic degenerative spondylolisthesis grade I and II (Meyerding Classification).
- •Subject displays drug or alcohol dependence, serious current illness, mental illness or extenuating circumstance or any other factors which, in the opinion of the Investigator, will interfere with study conduct or interpretation of the results.
- •Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfect, or osteomalacia.
- •Subject with poorly controlled diabetes mellitus as assessed by glycohaemoglobin (HbA1c) \> 8% (at least 2 values per year for last 2 years)
- •Subject is underweight, i.e. body mass index (BMI) ≤18.5 or has a BMI of ≥40, or ≥35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes at V0a.
- •Overt or active local or systemic infection, including latent infection around (area of) the future surgical implant site.
- •Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated on in this study. Decompressive surgery alone (laminectomy) is not an exclusion criterion.
Outcomes
Primary Outcomes
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 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 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 (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 (nocc AESI)
Time Frame: 24 months
Number of Adverse Events of Special Interest (AESI) using lumbar spine CT and radiographic images.
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
Secondary Outcomes
- NVD-001 (LSF)(24 months)
- NVD-001 (timeSurgery)(1 day)
- NVD-001 (subsequentSurgery)(24 months)
- NVD-001 (ODI)(24 months)
- NVD-001 (QoL)(24 months)
- NVD-001 (stayPostOp)(7 days)
- NVD-001 (BPI)(24 months)
- NVD-001 (OTE)(24 months)