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    Summary
    EudraCT Number:2022-001282-12
    Sponsor's Protocol Code Number:NVD003-CLN02-CPT
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2022-001282-12
    A.3Full title of the trial
    A proof-of-concept study with NVD-003, an autologous osteogenic bone graft, in the treatment of congenital pseudarthrosis of the tibia in pediatric patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant for the treatment of the children patients with congenital pseudarthrosis of the tibia
    Étude de validation de concept avec NVD-003, une greffe osseuse autologue, dans le traitement de la pseudarthrose congénitale du tibia chez les patients pédiatriques.
    A.4.1Sponsor's protocol code numberNVD003-CLN02-CPT
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05693558
    A.5.4Other Identifiers
    Name:INDNumber:27221
    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
    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 pointRegulatory Clinical
    B.5.3 Address:
    B.5.3.1Street AddressWatson & Crick Hill, Rue Granbonpré 1
    B.5.3.2Town/ cityMont-Saint-Guibert
    B.5.3.3Post code1435
    B.5.3.4CountryBelgium
    B.5.6E-mailregulatory@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-003
    D.3.2Product code NVD-003
    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 HA/TCP
    D.3.9.2Current sponsor codeNVD-003
    D.3.9.3Other descriptive nameNVD-003
    D.3.9.4EV Substance CodeSUB191550
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number20
    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) Yes
    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 No
    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
    congenital pseudarthrosis of the tibia (CPT)
    E.1.1.1Medical condition in easily understood language
    CPT is a rare disorder that manifests itself as a non-union or pseudarthrosis of fractures that develop spontaneously or following minor trauma.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess the safety of the NVD-003 treatment, including the Adipose tissue collection procedure and the NVD-003 grafting surgery
    E.2.2Secondary objectives of the trial
    To assess radiological and clinical efficacy of NVD-003
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female pediatric patients:
    a. Diagnosed with congenital pseudarthrosis of the tibia (with or without NF1) and presenting with a non-healing Paley type 3 or 4 fracture.
    b. With a minimum weight of 5kg/11lbs.
    c. Within the age range of 2 years to 8 years.
    2. Maximum 2 previous failed surgical orthopedic interventions to treat the primary CPT fracture.
    3. Patient fulfills criteria for undergoing a surgical intervention (ATC and GS) as per standard of care.
    4. Patient has serology and molecular test results excluding the presence of Human T-cell lymphoma virus (HTLV1/2), human immunodeficiency virus (HIV 1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis
    5. Possibility to obtain a minimum of 2cc/ 0.07fl.oz. (preferably up to 10cc/ 0.34fl oz) of adipose tissue.
    6. Satisfactory general health condition to undergo surgeries (ATC and GS) with anesthesia as per local standards.
    7. The fracture and patient baseline characteristics allow the application of a pre-defined standardized surgical procedure.
    8. A NVD 003 graft volume need not exceeding 20cc (0.68fl oz), confirmed by the treating orthopedic surgeon based on radiological measurements. The estimated volume should cover the total of the residual tibial bone defect volume of 0.5 to 1cm (0.2 0.39in) in height, the cross-union tibial bone-fibula volume and the eventual fibular bone defect volume.
    9. The patient’s parent(s) and/or legal guardian(s) provided written informed consent and accepted the participation of the patient in the trial.
    E.4Principal exclusion criteria
    1. Bilateral CPT.
    2. Presence of CPT without a fracture of the tibia (Paley type 1 and 2).
    3. More than 2 failed surgical attempt(s) to treat the primary tibial fracture.
    4. Evidence of plexiform neurofibroma of any size or nodular fibroma ≥ 1.2in/3cm on the ipsilateral leg.
    5. Clinically significant infection at the target grafting site or systemic infection.
    6. History of allergic reaction or any anticipated hypersensitivity to any anesthetic agent or any potential hypersensitivity to any of the components of the NVD-003 graft (including the CMRL1066 transport medium).
    7. CPT fracture requiring the use of one of the following surgical techniques:
    a. An external fixation system (e.g. Ilizarov, TSF, rail, …);
    b. A carrier or scaffold;
    c. An autogenous recombinant human bone morphogenetic protein.
    8. Presence of clinically significant hematologic, renal, hepatic, and coagulation laboratory abnormalities (i.e., CBC, PT/INR, Chem-7, and LFTs, etc.).
    9. Presence of any auto-immune disease, with exception of well controlled diabetes type 1 or auto-immune thyroid disorders.
    10. Any history of experimental therapy with another investigational drug within 60 days prior to screening.
    11. Presence of active tumor.
    12. Documented metabolic bone disease or any disorder, such as but not limited to osteogenesis imperfecta and osteomalacia, that could interfere with the bone healing and bone metabolism.
    13. Chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, anticoagulant therapies, immunosuppressant therapy or immunotherapy.
    14. Patient was breastfed less than 1 year before the lipo-aspiration.
    15. Any condition which, in the opinion of the investigator, could interfere with trial conduct, the patient’s compliance with the protocol or influence interpretation of the results.
    E.5 End points
    E.5.1Primary end point(s)
    To locally assess clinical and radiological safety (Short and midlong term)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assess short (≤3 months) and mid long-term (>3-12 months) NVD 003 related (S)AEs and the surgical reintervention rate, between screening (V1) and 12 months post-GS included (V8 included)
    E.5.2Secondary end point(s)
    • Assess long-term (>12-24 months) NVD 003 related SAEs after 12 months post-GS (V8 excluded) until 24 months
    • To centrally assess bone formation at 3-, 6-, and 12-months post-GS based on Computed Tomography scans (CT)
    • To centrally assess bone union and remodeling at 12 months post-GS based on CT
    • To centrally explore different quantitative bone parameters at GS, 3-, 6-, and 12-months post-GS based on CT and Dual Energy Computed Tomography (DECT) (including but not limited to NVD 003 density, composition of NVD 003 and surrounding tissue and bone mineral density)
    • To locally assess the clinical status of the patient by means of the “Clinical Global Impression” evaluated by the investigator at screening, hospital discharge, 6 weeks, 3, 6, 12 and 24 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 3, 6, 12 for short term safety and efficacy
    • 24 months for long term safety
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    exploratory (proof-of-concept) in pediatric patients
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Belgium
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pediatric patients age range 2-8 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2
    F.4.2.2In the whole clinical trial 4
    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 Decision2022-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-02
    P. End of Trial
    P.End of Trial StatusOngoing
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