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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000026062 |
Receipt No. | R000029156 |
Scientific 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). |
Date of disclosure of the study information | 2017/02/08 |
Last modified on | 2019/08/13 |
Basic information | ||
Public 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). | |
Acronym | Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis. ( Spine1 ) | |
Scientific 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). | |
Scientific Title:Acronym | Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis. ( Spine1 ) | |
Region |
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Condition | ||
Condition | Spondylolisthesis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety (local and systemic) of a specific surgical intervention with the use of NVD 001 (AEs, AESI, SAEs) in patients with symptomatic low-grade degenerative spondylolisthesis grade I or II undergoing surgery for spinal fusion of one vertebral segment (L1-S1). |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Explanatory |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | During the first year post surgery, safety will be assessed by:
- Collecting all adverse events for incidence, severity, relatedness, required action and outcome. - Collecting all SAEs (also SAEs during second year follow-up) - Collecting Adverse Events of Special Interest (AESI) (also at 24 months post-surgery) as part of local and systemic toxicity such as: Signs of local toxicity of experimental product will be evaluated on CT and radiographic images by local and independent radiologist and include: -- Trabecular bone resorption -- Intravertebral cystic changes -- Soft tissue calcification/ossification -- Peridiscal soft tissue swelling -- Hyperostosis -- Tumour growth Signs of systemic toxicity will be evaluated on chest radiographs by local radiologist and include appearance of calcification/ ossification on serial X-rays in comparison with preoperative X-rays. -- Ectopic bone formation - Surgical intervention-related safety parameters - Safety laboratory parameters - Safety evaluations including Electrocardiography, vital signs, physical and neurological examinations |
Key secondary outcomes | - Evaluation of fusion will be assessed on CT-Scans(*) at 6, 9, 12 and 24 months post-surgery by qualitative visual analysis called the "bridging trabecular bone scale" (Sys et al, 2011).
(*) Coronal and sagittal computed tomography scan: spiral CT with thin acquisition of axial images, in Digital Imaging and Communications in Medicine (DICOM) format. - Evaluation of Non-fusion will be assessed on Dynamic Radiographs at 6, 9, 12 and 24 months post-surgery and considered as non-fusion if at least one of the following signs occurs: translational motion more than 3 mm; angular motion more than 5deg; vacuum phenomenon in operated disc. - Evaluation of bone production will be done on CT images and will be quantified by using specific software at 6, 9, 12 and 24 months post-surgery. Two quantitative parameters will be addressed on serial CT with discharge CT data as baseline (of the patient's spine condition): -- Surface of new bone production (Huang et al, 2014) -- Determination of Hounsfield Unit (HU) in selected areas (in the PEEK cage(s) and in the entire disc). - Functional assessment by means of Oswestry Disability Index (ODI) at screening, 1, 6, 9, 12 and 24 months post-surgery. - Pain assessment by means of Brief Pain Inventory (BPI) at screening, pre-operation, discharge, 1, 6, 9, 12 and 24 months post-surgery. - Overall Treatment Effect scale (OTE) at 1, 6, 9, 12 and 24 months post-surgery. - Quality of life assessment by means of questionnaire EuroQoL 5 Dimensions (EQ-5D-5L) at screening, 9, 12 and 24 months post-surgery. - Surgical parameters such as duration of surgery, duration of postoperative hospital stay, subsequent surgical interventions (revision, removal, reoperation and supplemental fixation). |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Experimental: NVD-001
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. |
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Interventions/Control_2 | Active Comparator: Standard of Care
Best standard of care in surgical practice At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally harvested cancellous bone (laminectomy) |
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | -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. -Safety laboratory test results and pre-surgery serology are clinically acceptable to undergo surgery as applicable Serology panel for HIV, HBV, HCV, HTLV I/II and syphilis must be negative. -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. |
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Key exclusion criteria | -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 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) <= to 18.5 or has a BMI of >= to 40, or >= to 35 and experiencing obesity-related health conditions, such as high blood pressure or diabetes. -Overt or active local or systemic infection. -Subject has a history of previously attempted spinal fusion at the same level, or spine level immediately adjacent to the level to be operated. Decompressive surgery alone (laminectomy) is not an exclusion criterion. -Pregnant or breast-feeding woman. -Subject had an acute fracture of the spine within 6 months prior enrolment in the study. -Subject is currently taking chronically any medications that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressants or immunotherapy. -Subject is positive for human immunodeficiency virus (HIV) 1 or 2, hepatitis B or C, human T-cell lymphotropic virus (HTLV) 1 or 2, or syphilis at screening. -Any clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the patient. -Subject is on chronic immunosuppressive therapy due to inflammatory or systemic disease. -Subject has a history of any autoimmune disease. -(other crietria apply) |
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Target sample size | 36 |
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Name of lead principal investigator |
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Organization | Saint-Luc University Hospital
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Division name | Department of Neurosurgery | ||||||
Zip code | 1200 | ||||||
Address | Hippocrate Avenue 10 - 1200 Brussels - Belgium | ||||||
TEL | 3227641088 | ||||||
christian.raftopoulos@uclouvain.be |
Public contact | |||||||
Name of contact person |
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Organization | Novadip Biosciences | ||||||
Division name | Medical Officer | ||||||
Zip code | 1435 | ||||||
Address | Watson and Crick Hill, Rue Granbonpre 11 Bldg, B-1435 Mont-Saint-Guibert - Belgium | ||||||
TEL | 3210779220 | ||||||
Homepage URL | https://www.novadip.com/ | ||||||
clinical@novadip.com |
Sponsor | |
Institute | Novadip Biosciences
Watson and Crick Hill Rue Granbonpre 11 B-1435 Mont-Saint-Guibert - Belgium |
Institute | |
Department |
Funding Source | |
Organization | Novadip Biosciences
Watson and Crick Hill Rue Granbonpre 11 B-1435 Mont-Saint-Guibert - Belgium |
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Category of Funding Organization | Outside Japan |
Nationality of Funding Organization | Belgium |
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IRB Contact (For public release) | |
Organization | Comite d Ethique Hospitalo-Facultaire Universite Catholique de Louvain Faculte de medecine |
Address | Avenue Hippocrate 55-14, Tour Harvey niv 0, 1200 Brussel- Belgium |
Tel | 3227645514 |
commission.ethique-saint-luc@uclouvain.be |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | EudraCT 2016-002642-23 |
Org. issuing International ID_1 | EMA |
Study ID_2 | NCT03100032 |
Org. issuing International ID_2 | U.S. National Institutes of Health |
IND to MHLW |
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Institutions | (none in Japan) |
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Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029156 |
Research Plan | |
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