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    Summary
    EudraCT Number:2014-002416-16
    Sponsor's Protocol Code Number:ALLOB-RIF1
    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:2014-07-18
    Trial results View 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 number2014-002416-16
    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 Rescue Interbody 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 Rescue Interbody Fusion
    A.3.2Name or abbreviated title of the trial where available
    ALLOB-RIF1
    A.4.1Sponsor's protocol code numberALLOB-RIF1
    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.rif1@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 IMPIntraosseous use
    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
    Failed lumbar fusion
    E.1.1.1Medical condition in easily understood language
    Failed lumbar fusion
    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 10050238
    E.1.2Term Spinal fusion NOS
    E.1.2System Organ Class 100000021566
    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 rescue interbody fusion over 12 months in patients suffering from failed lumbar fusion at one or two level(s).
    Safety:
    At each visit, subjects will be assessed for the potential occurrence 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:
    The efficacy of the treatment will be evaluated at Month 12:
    - Radiologically (progression of the lumbar fusion): the Fusion Score as assessed by CT-scan vs. baseline.
    - Clinically (functional disability): the changes in ODI 2.1a vs. baseline.
    E.2.2Secondary objectives of the trial
    The other efficacy endpoints are:
    -Number of patients requiring a rescue surgery for failed rescue fusion
    -Changes in ODI 2.1a at each FU visit
    -Changes in Back and Leg Pain VAS at each FU visit
    -Changes in Global Disease Evaluation VAS at each FU visit
    -Lumbar fusion progression using the Fusion Score at Month 6, 9, 12
    -Mean time to lumbar fusion
    -Changes of intervertebral mobility at Month 6, 9, 12
    -Integrity of instrumentation and surrounding bones at Month 6, 9, 12
    -Changes of segmental lordosis at Month 6, 9, 12
    -Changes of lumbar lordosis at Month 6, 9, 12
    -Changes of disc height at Month 6, 9, 12
    -Assessment of bone metabolism at each FU visit
    -Blood loss during procedure
    -Operating time
    -Number of per- and post-operative complications
    -Hospital stay duration
    -Assessment of ALLOB® biodistribution at Hour 4, 24, 48, 72
    -Assessment of bone remodelling/formation at Month 3, 6, 9
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALLOB® biodistribution and bone remodelling/formation
    The objective of this sub-study is to investigate the biodistribution, locally and systematically, of radio-labelled ALLOB® cells after the implantation at the failed lumbar fusion level. The timepoints for biodistribution are 4 ± 2 hours (if the patient is capable to undergo the procedure), 24 ± 4 hours, 48 ± 4 hours and 72 ± 4 hours post-implantation.
    An additional objective is to assess the healing process (bone remodelling/formation) of the failed lumbar fusion level. The timepoints for bone remodelling/formation are the day before implantation, 3 Months, 6 Months and 9 Months post-implantation.
    The biodistribution sub-study will only be conducted on maximum 6 patients in a single centre.
    E.3Principal inclusion criteria
    - Man or woman aged of minimum 18 years old (at the time of treatment)
    -Diagnosed with a failed lumbar interbody fusion procedure at the time of ALLOB® treatment:
    - Defined radiologically (as judged by the Investigator)
    - Of a minimum of 15 months follow-up
    - Requiring a revision surgery at one or two level(s) between L1 to S1
    - 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 two previous spinal surgeries at the lumbar level(s) not involving instrumentation withdrawal
    - More than two failed interbody fusion at the involved lumbar level(s)
    - Local active or latent infection at the involved lumbar level(s)
    - Instrumentation failure (e.g., pedicle screw, interbody cage) requiring revision surgery
    - Extra-spinal cause of back pain, such as trauma, infection, or tumour at the involved lumbar level(s)
    - Requiring surgery within the next 12 months (at the time of the implantation)

    Current or previous diagnoses, signs and/or symptoms
    - Positive serology for HIV (defined as positive Anti-HIV 1 and/or 2 and/or positive PCR)
    - Active hepatitis B (defined as positive HBs Ag and/or positive PCR)
    - Active hepatitis C (defined as positive Anti-HCV and/or positive PCR)
    - Global sepsis
    - Severe renal (defined as a creatinine clearance value < 30 ml/min, calculated with the Cockcroft-Gault formula) or severe 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
    - Known allergy to contrast agent (only in case of use of contrast agent during implantation procedure)
    - 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 for cured cancers such as non-metastatic thyroid cancer, seminoma, 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 (except for cured cancers such as non-metastatic thyroid cancer, seminoma, non-melanoma skin cancer..)
    - 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:
    From the beginning to the end of the main study period at Month 12, study participants will be systematically assessed for the potential occurrence of any AE and SAE related or not to the treatment (i.e., ALLOB® or implantation procedure), using subject open questionnaires, physical examinations and laboratory measurements.
    Selected safety data will also be investigated during an additional post-study safety follow-up 12 months and 24 months after the end of the study.
    Efficacy criteria:
    The following clinical and radiological criteria will be used:
    - Radiologically (progression of the lumbar fusion): the Fusion Score as assessed by CT-scan (vs. baseline)
    - Clinically (functional disability): the changes in ODI 2.1a vs. baseline
    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 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 for failed rescue fusion at one or more level(s)
    - Changes in ODI 2.1a at each follow-up visit (vs. baseline)
    - Changes in Back and Leg Pain VAS at each follow-up visit (vs. baseline)
    - Changes in Global Disease Evaluation VAS at each follow-up visit (vs. baseline)
    - Lumbar fusion progression at the treated level(s) using the Fusion Score as assessed by CT-scan at Month 6, 9 and 12
    - Mean time to lumbar fusion at the treated level(s) as assessed by CT-scan
    - Changes of intervertebral mobility at the treated level(s) as assessed by X-ray at Month 6, 9 and 12 (vs. baseline)
    - Integrity of instrumentation and surrounding bones at the treated level(s) as assessed by CT-scan and X-ray at Month 6, 9 and 12
    - Changes of segmental lordosis at treated level(s) as assessed by X-ray at Month 6, 9 and 12 (vs. baseline)
    - Changes of lumbar lordosis as assessed by X-ray at Month 6, 9 and 12 (vs. baseline)
    - Changes of disc height at the treated level(s) as assessed by CT-scan at Month 6, 9 and 12 (vs. baseline)
    - Assessment of bone metabolism using bone biomarkers at each follow-up visit (vs. baseline)
    - Loss of blood during procedure
    - Operating time
    - Number of per-operative and post-operative complications
    - Duration of hospital stay
    - Assessment of ALLOB® biodistribution at Hour 4, 24, 48 and 72
    − Assessment of bone remodelling/formation at Month 3, 6 and 9 (vs. baseline)
    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 concerned3
    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 Yes
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state16
    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-RIF1
    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 Decision2014-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-25
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