Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-004480-31
    Sponsor's Protocol Code Number:ALLOB-IF1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-21
    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 number2013-004480-31
    A.3Full title of the trial
    A Pilot Phase IIa, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) implantation in Lumbar Spinal Fusion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pilot Phase IIa, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) implantation in Lumbar Spinal Fusion
    A.3.2Name or abbreviated title of the trial where available
    ALLOB-IF1
    A.4.1Sponsor's protocol code numberALLOB-IF1
    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 SponsorBone Therapeutics 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 supportBone Therapeutics S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBone Therapeutics S.A.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressRue Auguste Piccard, 37
    B.5.3.2Town/ cityGosselies
    B.5.3.3Post code6041
    B.5.3.4CountryBelgium
    B.5.6E-mailallob.if1@bonetherapeutics.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 nameALLOB® 4 ml
    D.3.2Product code ALLOB® 4 ml
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNALLOB® cells
    D.3.9.2Current sponsor codeALLOB® cells
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 10E6
    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 numberIt has been classified as a tissue engineering product (non-combined) (reference : EMA/647468/2011) by the EMA on July 1, 2011 (as defined in Article 2(1)(a-d) 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
    Degenerative disc disease
    E.1.1.1Medical condition in easily understood language
    Degenerative disc disease
    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 10070241
    E.1.2Term Degenerative disc disease
    E.1.2System Organ Class 100000018941
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the safety and efficacy of ALLOB® in spinal fusion over 12 months in spinal fusion in patients with symptomatic disc disease of the lumbar spine.
    Safety:
    Subjects will be systematically assessed for the potential occurence of any AE and SAE related or not to the treatment (i.e., ALLOB®/β-TCP mix or surgical procedure), using subject open questionnaires, physical examinations and laboratory measurements.
    Efficacy:
    The efficacy of the treatment will be evaluated at Month 12:
    - clinically (functional disability): the improvement in ODI 2.1a vs. baseline visit
    -radiologically (progression of the lumbar fusion): the mean Lumbar Fusion Score as assessed by CT-scan.
    E.2.2Secondary objectives of the trial
    -Number (%) of patients requiring a rescue surgery at Month 6, 9, 12
    -Improvement in ODI 2.1a at each follow-up visit (vs. baseline visit)
    -Improvement in Back and Leg Pain VAS at each follow-up visit (vs. baseline visit)
    -Improvement in Global Disease Evaluation VAS at each follow-up visit (vs. baseline visit)
    -Lumbar fusion progression using the Lumbar Fusion Score as assessed by CT-scan at Month 3, 6, 12 (vs. baseline value)
    -Mean time to lumbar fusion as assessed by CT-scan
    -Evolution of the intervertebral mobility at Month 3, 6, 9, 12 (vs. baseline visit)
    -Integrity of instrumentation and surrounding bones at Month 3, 6, 9, 12
    -Evolution of segmental lordosis at Month 3, 6, 9, 12 (vs. baseline visit)
    -Evolution of lumbar lordosis at Month 3, 6, 9, 12 (vs. baseline visit)
    -Evolution of disc height at Month 3, 6, 12 (vs. baseline value)
    -Loss of blood during procedure
    -Operating time
    -Number of per-operative and post-operative complications
    -Duration of hospital stay
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Man or woman aged 18 to 75 years (inclusive)
    - Diagnosed with lumbar degenerative disc disease
    - Symptomatic with an ODI 2.1a score ≥ 30
    - Demonstrated radiologically
    - Requiring a single level lumbar fusion (L1 to S1)
    - Unresponsive to non-operative treatment (e.g., medication, physical therapy) for at least 6 months at the time of screening
    - Capable to provide a written, dated, and signed informed consent and to understand and comply with the study requirements
    E.4Principal exclusion criteria
    Current symptoms and/or signs related to the disease under study
    - More than one previous spinal surgery at the involved lumbar level
    - Previous failed fusion at the involved lumbar level
    - Local active or latent infection at the involved lumbar level
    - Requiring surgery at more than one-level of the lumbar spinal region within the next 12 months
    - Diagnosis of non-union, fracture or tumour at the involved lumbar level
    - Diagnosis of multilevel scoliosis or adjacent segment syndrome at the lumbar spine
    - Diagnosis of high-grade isthmic/lytic spondylolisthesis (grade > III) requiring multi-level lumbar fusion

    Current or previous diagnoses, signs and/or symptoms
    - Highly communicable diseases (i.e., HIV, active hepatitis B or C (defined as positive HBs Ag and/or positive PCR), active tuberculosis, syphilis)
    - Global sepsis
    - Severe renal (defined as a creatinine clearance value < 30 ml/min, calculated with the Cockcroft-Gault formula) or hepatic impairment (defined as alanine aminotransferase or aspartate aminotransferase ≥ 3 times the upper normal limit)
    - Severe diabetes (defined as HbA1C > 8%)
    - Severe allergy or anaphylaxis
    - Known allergy to gentamicin
    - Medical condition that can inhibit bone healing (e.g., severe osteoporosis (as defined by T-score <-3 or presence of 2 or more fractures), Paget’s disease, osteomalacia)
    - Medical condition that could interfere with study participant assessment (e.g., neuromuscular disease, psychiatric disease, paraplegia)
    - Active autoimmune disease (e.g., sclerodermia, Sjögren syndrome, lupus)
    - Current or past (within 5 years) malignant neoplasia (except non-metastatic thyroid cancer and non-melanoma skin cancer)
    - Poor general health or concomitant disease that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease)
    - History of organ or bone marrow transplantation
    - History of hypersensitivity to human biological material including blood and blood derived products, documented clinically or by laboratory tests
    Current or previous treatment
    - Previous treatment with ALLOB®
    - Participation (within 3 months of screening) in another clinical study involving a pharmacological agent
    - Current or past treatment (within 5 years of screening) for cancer or blood dyscrasia, including but not limited to chemotherapy, radiotherapy, immunotherapy, biotherapy, haematopoietic growth factors and/or anti-angiogenesis treatment
    - Current (within 6 months of screening) illicit drug abuse (as per local law)

    Safety aspects concerning female subjects with childbearing potential
    - Positive Urine Pregnancy test
    - Pregnancy
    - Breast-feeding
    - Woman with childbearing potential not willing or not able to use reliable contraceptive method for at least 6 weeks prior to screening and during the whole study period (reliable contraceptive methods include orally administered hormonal contraceptives, intrauterine device or surgical intervention (e.g., tubal ligation)

    Other exclusion criteria
    - Body Mass Index (BMI) ≥ 35 kg/m2
    - Clinically relevant abnormal ECG (>6-lead or according to standard of care at the hospital), as judged by the Investigator or any medically qualified member of the study care team
    - Unable to undergo general anaesthesia or a surgical intervention
    E.5 End points
    E.5.1Primary end point(s)
    Safety criteria:
    At each visit, subjects will be assessed for the potential occurence of any AE or SAE related to the product or to the procedure, using patient open non-directive questionnaires, vital signs and laboratory measurements.
    Efficacy criteria:
    The efficacy of the treatment will be evaluated at Month 12:
    - Clinically (functional disability): the improvement in ODI 2.1a vs. baseline visit
    Radiologically (progression of the lumbar fusion): the mean Lumbar Fusion Score as assessed by CT-scan
    E.5.1.1Timepoint(s) of evaluation of this end point
    The following time points will be used to evaluate over the 12-month follow-up period:
    - Clinical endpoints at baseline and at 6 weeks, 3, 6, 9 and 12 months
    - Radiological endpoints at baseline and at 3, 6, 9 and 12 months.
    Safety endpoints will be determined at each scheduled visit over the 12-month follow-up period.
    E.5.2Secondary end point(s)
    The other endpoints will be:
    - Number (percentage) of patients requiring a rescue surgery at Month 6, 9 and 12
    - Improvement in ODI 2.1a at each follow-up visit (vs. baseline visit)
    - Improvement in Back and Leg Pain VAS at each follow-up visit (vs. baseline visit)
    - Improvement in Global Disease Evaluation VAS at each follow-up visit (vs. baseline visit)
    - Lumbar fusion progression using the Lumbar Fusion Score as assessed by CT-scan at Month 3, 6 and 12 (vs. baseline value)
    - Mean time to lumbar fusion as assessed by CT-scan
    - Evolution of the intervertebral mobility at Month 3, 6, 9 and 12 (vs. baseline visit)
    - Integrity of instrumentation and surrounding vertebral bones at Month 3, 6, 9 and 12
    - Evolution of segmental lordosis at Month 3, 6, 9 and 12 (vs. baseline visit)
    - Evolution of lumbar lordosis at Month 3, 6, 9 and 12 (vs. baseline visit)
    - Evolution of disc height at Month 3, 6 and 12 (vs. baseline value)
    - Loss of blood during procedure
    - Operating time
    - Number of per-operative and post-operative complications
    - Duration of hospital stay
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints will be determined at each scheduled visit over the 12-month follow-up period.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) No
    E.7.1.1First administration to humans No
    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 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 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 concerned8
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state32
    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)
    As described in the protocol ALLOB-IF1
    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 Decision2014-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-25
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 02:25:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA