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    Summary
    EudraCT Number:2017-002092-25
    Sponsor's Protocol Code Number:9766
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002092-25
    A.3Full title of the trial
    A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of intradiscal injection of BM-MSC in subjects with chronic LBP due to lumbar DDD unresponsive to conventional therapy.
    A.4.1Sponsor's protocol code number9766
    A.5.4Other Identifiers
    Name:Dépôt phase nationaleNumber:VHP 1207
    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 SponsorUniversity Hospital of Montpellier
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportH2020
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital of Montpellier
    B.5.2Functional name of contact pointChristian Jorgensen
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Lapeyronie, 191 avenue du Doyen Gaston Giraud
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number+33467337796
    B.5.5Fax number+33467337227
    B.5.6E-mailc-jorgensen@chu-montpellier.fr
    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 name Bone Marrow allogeneic mesenchymal stromal cells
    D.3.2Product code MSV2
    D.3.4Pharmaceutical form Concentrate for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradiscal use
    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 Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    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 numberIMP 15-007 asigned to "allogeneic mesenchymal stem cells manufactured by the IBGM cell production Unit of Valladolid University" by NCA
    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
    Chronic low back pain
    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
    - Co-Primary objectives:
    To evaluate the efficacy of intradiscal injection of allogeneic BM-MSCs in reducing chronic low back pain due to lumbar DDD using the visual analog scale (VAS) and functional status assessed by the Oswestry disability index (ODI) after 12 months of treatment, defining a responder as a patient with an improvement of VAS for pain of at least 20% and 20 mm between baseline and month 12, or with an improvement of ODI of 20% between baseline and month 12.

    To evaluate the efficacy of intradiscal injection of BM-MSCs in increasing disc fluid content, measured by quantitative Magnetic Resonance Imaging, between baseline and month 12.

    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of intradiscal injection of allogeneic BM-MSCs using VAS and ODI after 3, 6 and 24 months of treatment, defining responders in case of at least 20% of improvement in VAS for pain compared to Baseline.
    - Assess efficacy of allogeneic stem cell treatments for DDD on modification of VAS between baseline and 3, 6, 12 and 24 months.
    - Evaluate modification of disability (ODI),quality of life (SF-12 scores), overall pain intensity, and global assessment by the patient and the physician, between baseline and 3, 6 , 12 and 24 months.
    - Evaluate modification of affected disc by quantitative Magnetic Resonance Imaging (MRI) between baseline, 6, 12, and 24 months
    - Assess modification of employment and work status between baseline and months 12 and 24.
    - Assess safety and tolerability, measured by the number of participants with adverse events.
    - Assess immune response associated with allogeneic cells injection
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The biological effect of the MSC injection on recipient immune response assessement for 60 patients
    E.3Principal inclusion criteria
    - Age between 18 and 60 years.
    - Symptomatic chronic low back pain unresponsive to conservative therapy (including physical therapy) for at least 3 months.
    - DDD assessed by (Pfirrmann’s score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann’s score 1-4 maximum)
    - Low back Pain baseline > 40 mm on VAS (0-100).
    - NSAID washout of at least 2 days before screening
    - Painkillers washout of at least 24 hours before screening
    E.4Principal exclusion criteria
    - Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralization and hemisacralization).
    - Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on Xray or MRI (osteophyte and facet hypertrophy).
    - Prior to the screening visit, has received:
    o Oral corticosteroid therapy within the previous 3 months, OR
    o Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months
     Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation > 3 mm and/or angular mobility > 15°).
     Spinal canal stenosis (Schizas score > B).
     History of spinal infection.
     Lumbar disc herniation with non truncated sciatica or cruralgia.
     Previous discal puncture or previous spine surgery.
     DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases
     Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
     Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
    - Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of <100 × 109/L.
    - Significant medical problems, such as uncontrolled hypertension, symptomatic heart failure; or any other clinically relevant condition or current medication that in the opinion of the investigator contra-indicates the use of any of the study or rescue medications.
    - Positive serology for following viral infection: HIV, Hepatitis B, or Hepatitis C.
    - Contraindication to MRI assessed by the investigator.
    - Intolerance or allergy to local anaesthesia.
    - Any history of Cancer or immunodeficiency disease.
    - Previous transfusion or transplantation.
    E.5 End points
    E.5.1Primary end point(s)
    The clinical response is defined as pain relief of at least 20% and 20 mm decrease on VAS scale between baseline and month 12, or 20% improvement of functional index ODI at month 12 compared to Baseline

    Fluid content of the discs will be determined from T2-weighted sagittal images, and measured in the affected disc segment and in the contiguous 3 to 5 segments (Methods and Orozco et al).. The change in fluid content is expressed as the ratio of fluid content at month 12 vs fluid content at baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    Disability and quality of life evolution
    Employment and work status
    Structural assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    0, 3, 6, 12 and 24 months
    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 No
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    Control group with a sham procedure including local anaesthesia
    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 EEA9
    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
    LVLP
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 112
    F.1.3Elderly (>=65 years) No
    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 No
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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)
    Patients will be followed up for 5 years long term after study termination for safety assessement.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ecrin european clinical research infrastructures network
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Spanish Cell Therapy Network (TerCel)
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
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