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    Summary
    EudraCT Number:2016-002642-23
    Sponsor's Protocol Code Number:NVD-CLN01
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2016-002642-23
    A.3Full title of the trial
    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). (The NVD-001 Spine1 Study)
    Prospektivní, multicentrická, randomizovaná, kontrolovaná studie za účelem vyhodnocení bezpečnosti a předběžné účinnosti NVD-001 pro léčbu degenerativní spondylolistézy nízkého stupně meziobratlovou fúzí (L1-S1).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety and effectiveness of NVD-001 for the treatment of low-grade degenerative spondylolisthesis
    Studie ke vyhodnoceni bezpecnosti a ucinnosti NVD-001 pro lecbu degenerativni spondylolistezi nizkeho stupne
    A.3.2Name or abbreviated title of the trial where available
    NVD-001 Spine1
    NVD - 001 Spine 1 Studie
    A.4.1Sponsor's protocol code numberNVD-CLN01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03100032
    A.5.4Other Identifiers
    Name:UMINNumber:UMIN000026062
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovadip Biosciences S.A.
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovadip Biosciences
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovadip Biosciences
    B.5.2Functional name of contact pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressRue Granbonpré 11
    B.5.3.2Town/ cityMont-Saint-Guibert
    B.5.3.3Post code1435
    B.5.3.4CountryBelgium
    B.5.4Telephone number3210779220
    B.5.5Fax number3210779221
    B.5.6E-mailclinical@novadip.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNVD-001
    D.3.2Product code NVD-001
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPImplantation
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous osteogenic cells in ECM with DBM
    D.3.9.3Other descriptive nameNVD-001
    D.3.9.4EV Substance CodeSUB183911
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number16.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberEMA/90882/2013 Tissue engineered product as provided in Article 2(1)(a) of Regulation (EC) No 1394/2007.
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1).
    Pacjenci z objawowym kręgozmykiem zwyrodnieniowym niskiego stopnia - I lub II stopień, poddawanych operacji fuzji międzytrzonowej jednego segmentu kręgowego (L1 - S1)
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with symptomatic degenerative spondylolisthesis grade I or II with an indication for spinal fusion of one vertebral segment (L1-S1).
    Pacjenci z objawowym kręgozmykiem zwyrodnieniowym niskiego stopnia - I lub II stopień, poddawanych operacji fuzji międzytrzonowej jednego segmentu kręgowego (L1 - S1)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077991
    E.1.2Term Lumbar spondylolisthesis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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).
    E.2.2Secondary objectives of the trial
    • To evaluate the safety (local and systemic) of a commonly used surgical intervention with the use of locally harvested cancellous bone (laminectomy).
    • To determine the clinical efficacy of one level spinal lumbar interbody fusion with NVD 001by imaging assessments.
    • To determine the clinical efficacy of one level spinal lumbar interbody fusion with locally harvested cancellous bone by imaging assessments.
    • For both groups:
    - Functional assessment
    - Pain assessment
    - Subsequent surgical interventions (revision, removal, reoperation and supplemental fixation)
    • For both groups:
    - To record peri- and postoperative blood loss
    - To record duration of surgery
    - To record the number of postoperative hospital days stays
    - To assess Overall Treatment effect evaluation
    - QoL assessment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has understood and accepted to participate in the study according to all study procedures by signing the approved informed consent.
    2. Male or female subjects aged ≥18 and skeletally mature (epiphyses closed) at Visit V0a.
    3. Subject has clinically important pain or neurological symptoms at V0a with or without claudication due to symptomatic degenerative spondylolisthesis grade I or II (Meyerding Classification: see Appendix A).
    4. Conservative treatment of disease has failed for at least 3 months since diagnosis. (ISASS 2011)
    5. Subject has a preoperative ODI score >30.
    6. 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.
    7. 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.
    8. 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.
    9. 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. (see Appendix B).
    10. 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. 11. 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
    E.4Principal exclusion criteria
    1. Subject has known history of hypersensitivity or anaphylactic reaction to PEEK.
    2. Due to medical or other reasons spine fusion cannot be delayed for up to 6 months.
    3. Indications for spinal fusion other than symptomatic degenerative spondylolisthesis grade I and II (Meyerding Classification: see Appendix A).
    4. 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.
    5. Subject has documented metabolic disease such as but not limited to severe osteoporosis, osteogenesis imperfecta or osteomalacia.
    6. Subject with poorly controlled diabetes mellitus as assessed by glycohaemoglobin (HbA1c) >8% (at least 2 values per year for last 2 years).
    7. 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.
    8. Overt or active local or systemic infection, including latent infection around (area of) the future surgical implant site.
    9. 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.
    10. Subject is on a transplant list or having received a solid organ transplant at any point in the past.
    11. Pregnant or breast-feeding woman.
    12. Involved in or planning to engage in litigation-related health problems.
    13. Subject is a prisoner.
    14. Subject had an acute fracture of the spine within 6 months prior to V0a in the study.
    15. Subject is known to require additional surgery to the lumbar spinal region within the next 2 years after enrolment in the study.
    16. 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.
    17. Subject is currently using an electrical bone growth stimulator.
    18. Subject is positive for human immunodeficiency virus (HIV) 1 or 2, hepatitis B (HBsAg or PCR positive) or C, human T-cell lymphotropic virus (HTLV) 1 or 2, or syphilis at screening (V0a).
    19. Subject was exposed to any experimental therapy with another investigational drug within 60 days prior to screening or enrolment in any concurrent study that may confound the results of this study.
    20. Subject previously received a cellular therapy (at any point in time).
    21. Subject was exposed to therapy for a malignancy or pre-malignant entity, and not confirmed disease-free for 5 years or more.
    22. 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.
    23. Any other illness which might reduce life expectancy to less than 2 years from screening.
    24. Subject is on chronic immunosuppressive therapy (immunosuppressants/immunotherapy) due to inflammatory or systemic disease.
    25. Subject has an active inflammatory systemic autoimmune disease that could interfere with bone metabolism such as but not limited to rheumatoid arthritis, ankylosing spondylarthritis, inflammatory bowel disease, systemic lupus erythematosus or thyroid diseases.
    E.5 End points
    E.5.1Primary end point(s)
    • 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
    o Signs of local toxicity of experimental product will be evaluated on CT and radiographic images by independent radiologist and include:
    • Trabecular bone resorption
    • Intravertebral cystic changes
    • Soft tissue calcification/ossification
    • Peridiscal soft tissue swelling
    • Hyperostosis
    • Tumour growth
    o Signs of systemic toxicity will be evaluated on chest radiographs and include appearance of calcification/ ossification on serial X-rays in comparison with preoperative X-rays.
    • Ectopic bone formation
    • Surgical intervention related safety parameters such as but not limited to:
    o Infection
    o Peri- and postoperative blood loss
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months post-surgery and follow-up at 24 months.
    E.5.2Secondary end point(s)
    • 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”.
    • Evaluation of Non-fusion will be assessed on Dynamic Radiographs at 6, 9, 12 and 24 months post-surgery and considered as at least one of the following signs occurs: translational motion > 3 mm; angular motion > 5°; 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.
    • 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-implant procedure.
    • 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).
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 9, 12 and 24 months post-surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best standard of care in surgical practice
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    posledni navsteva pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-09
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