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    Summary
    EudraCT Number:2019-002749-40
    Sponsor's Protocol Code Number:DREAM-GR-2018-12367168
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-002749-40
    A.3Full title of the trial
    Intervertebral Disc REgeneration mediated by Autologous Mesenchymal stem/stromal cells intradiscal injection: a phase IIB randomized clinical trial.
    Rigenerazione del disco intervertebrale mediante iniezione intradiscale di cellule staminali mesenchimali/stromali autologhe: studio clinico randomizzato di fase II B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of intradiscal injection of cells from the bone marrow in subjects with chronic back pain, caused by a degenerative disease affecting the vertebral idisc,which does not respond to traditional therapy.
    Efficacia dell'iniezione intradiscale di cellule provenienti dal midollo osseo in soggetti con mal di schiena cronico, causato da una malattia degenerativa che colpisce il disco vertebrale, che non risponde alla terapia tradizionale.
    A.3.2Name or abbreviated title of the trial where available
    DREAM
    DREAM
    A.4.1Sponsor's protocol code numberDREAM-GR-2018-12367168
    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 SponsorUNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
    B.1.3.4CountryItaly
    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 supportMinistero della Salute (Bando Ricerca Finalizzata)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione GIMEMA
    B.5.2Functional name of contact pointCentro Dati GIMEMA
    B.5.3 Address:
    B.5.3.1Street Addressvia Casilina, 5 Roma
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00182
    B.5.3.4CountryItaly
    B.5.4Telephone number0670390526
    B.5.5Fax number0670390540
    B.5.6E-mailgimema@gimema.it
    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 nameCellule staminali mesenchimali/stromali autologhe isolate da midollo osseo
    D.3.2Product code [auto BM-MSC]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradiscal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCellule staminali mesenchimali/stromali autologhe estratte da midollo osseo
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000000
    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 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
    Symptomatic chronic low back pain due to a degenerative disease of the intervertebral disc
    Lombalgia cronica sintomatica dovuta a malattia degenerativa del disco intervertebrale
    E.1.1.1Medical condition in easily understood language
    Low back pain is the chronic pain of the lower back due to the constant deterioration of the area between the two disks of the spine.
    La Lombalgia è il dolore cronico della parte bassa della schiena dovuta al costante deterioramento della zona presente tra i due dischi della colonna vertebrale.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10070241
    E.1.2Term Degenerative disc disease
    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
    The main objective is to evaluate the efficacy of intradiscal injection of autologous BM-MSC cells in reducing chronic low back pain (LBP) due to a multilevel lumbar intervertebral disc (IDD) degeneration (max. 3 levels) 24 months after treatment in terms of pain reduction (VAS), improved function (ODI) and quality of life (SF36).
    L'obiettivo principale è valutare l’efficacia dell’iniezione intradiscale di cellule autologhe BM-MSC nel ridurre la Lombalgia (LBP) cronica dovuta ad una degenerazione del disco intervertebrale (IDD) lombare multilivello (max. 3 livelli) dopo 24 mesi dal trattamento in termini di riduzione del dolore (VAS) miglioramento funzionalità (ODI) e qualità della vita (SF36).
    E.2.2Secondary objectives of the trial
    • Evaluate the regenerative changes of the treated discs.
    • Evaluate the change in employment and work status between the baseline and the 12 and 24 months.
    • Assess the safety and tolerability of the treatment.
    • Evaluate the use of drugs used to relieve pain, indicating the type and dose of analgesic.
    • Valutare le modifiche rigenerative dei dischi trattati.
    • Valutare la modifica dell’occupazione e dello stato di lavoro tra il baseline e i mesi 12 e 24.
    • Valutare la sicurezza e la tollerabilità del trattamento.
    • Valutare l’assunzione di farmaci utilizzati per alleviare il dolore, indicando il tipo e la dose di analgesico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects aged between 18 and 65 years.
    • Signed informed consent.
    • Chronic symptomatic LBP due to moderate IDD (Grade 3-4 according to Pfirrmann, grade 3-7 according to Griffith) at up to 3 levels of the lumbar spine, unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes AINS, paracetamol, opioids and myorelaxant. (For more details, see paragragh 1.1.4)
    • Annulus fibrosus intact, confirmed by magnetic resonance imaging (MRI).
    • Pain in the lumbar area at the baseline> 40 mm on the VAS scale (0-100).
    • Washout of NSAIDs at least 2 days before the screening visit.
    • Wshout of painkillers at least 24 hours before the screening visit.
    • Women of child-bearing age, they must take a pregnancy test at the time of the screening visit which must be negative.
    • Men and women should use effective contraception during treatment and for at least 24 months after stopping BM-MSC therapy. As a precautionary measure, breastfeeding should be discontinued during the study treatment period and should not be resumed after BM-MSC injections are stopped
    • Soggetti di età compresa tra i 18 e i 65 anni.
    • Consenso informato firmato.
    • Lombalgia cronica dovuta a degenerazione del disco intervertebrale di grado moderato (pfirmann modificato score 3-4) che coinvolge massimo 3 livelli del rachide lombare e che non risponde ai
    trattamenti conservativi, fisici o medici per almeno 6 mesi. I trattamenti fisici includono la fisioterapia. I trattamenti medici includono i FANS, paracetamolo, oppioidi e miorilassanti. (Consultare il
    paragrafo 1.1.4. del Protocollo per maggiori dettagli).
    • Annulus fibrosus intatto, confermato mediante la risonanza magnetica (MRI).
    • Dolore alla zona lombare al baseline > 40 mm sulla scala VAS (0-100).
    • Sospensione dei FANS da almeno 2 giorni prima della visita di screening.
    • Sospensione degli antidolorifici da almeno 24 ore prima della visita di screening.
    • Le donne in età fertile, devono effettuare un test di gravidanza al momento della visita di screening il quale deve risultare negativo.
    • Uomini e donne dovrebbero utilizzare metodi contraccettivi efficaci durante il trattamento e per almeno 24 mesi dopo l’interruzione della terapia con BM-MSC. Come misura precauzionale, l’allattamento al seno deve essere interrotto durante il periodo di trattamento previsto dallo studio e non deve essere ripreso dopo la sospensione delle iniezioni di BM-MSC
    E.4Principal exclusion criteria
    Congenital or acquired diseases that lead to a deformation of the vertebral column and can compromise the injection of cells (scoliosis, isthmus lesions, sacralization and hemisacralization, degenerative spondylolisthesis).
    • Instability of the spinal segment assessed by dimanic radiography of the column (RX)
    • Joint facet syndrome evaluated with MRI (hyperintensity and hypertrophy of the facet joints in T2-weighted images).
    • Patients who have taken before the screening visit:
    - Oral corticosteroid therapy in the three months prior to treatment,
    - Intramuscular, intravenous or epidural infusion of corticosteroids in the three months prior to treatment
    • Presence of a 4th level with symptomatic IDD, (Grade 3-4 according to Pfirrmann, grade 3-7 according to Griffith) at the vertebral column level.
    • Stenosis of the spinal canal (Schizas score> B).
    • Clinical history of spinal infections.
    • Disc herniation and sciatica.
    • Anomaly of the terminal disks, such as Schmorl's hernias.
    • Previous injections at the level of the disc or previous surgery on the spinal column.
    • IDD with Modic II and III modifications evaluated with images obtained from MRI.
    • Patients not suitable for intervertebral disc surgery.
    • Patients who have the risk of having surgery in the 6 months following inclusion in the study.
    • Patients with local infusion device/devices for corticosteroids.
    • Obese patients with a body mass index (BMI expressed as weight Kg / m2) greater than 35 (degree of obesity II).
    • Subjects participating in another clinical trial or being treated with another experimental medicine within 30 days prior to inclusion in the study.
    • Abnormal blood tests: hepatic values ¿¿(alanine transferase [ALT] and / or aspartate aminotransferase [AST]> 1.5 beyond the limits of the standard [ULN],
    • renal, pancreatic or biliary disorders, coagulation disorders, anemia and platelet counts <100 x 109 / L.
    • Women who are pregnant or nursing, or pre-menopausal women who do not use an acceptable precautionary contraceptive method, are not eligible for the study. Contraception should be maintained throughout the treatment period until the end of the study. An additional pregnancy test will be performed at the end of the study. Patients are required to use contraceptive methods from the start of treatment and up to 24 months after the last dose of the experimental medicine.
    • In any case of delay of the menstrual period (over an interval of one month between the two periods), it is strongly recommended to exclude the possibility of a possible pregnancy. The complete list of contraceptive methods is described in the patient information sheet and in section 6.5.
    • Serological positivity for the following infections: Syphilis, HIV, Hepatitis B or C
    • Not suitable for MRI evaluated by the investigator.
    • Intolerance or allergy to local anesthesia.
    • Any clinical history of cancer or immunodeficiency disease.
    • Previous transplant.
    • Malattie congenite o acquisite che comportano una deformazione della colonna vertebrale e possono compromettere l’iniezione delle cellule (scoliosi, lesioni dell’istmo, sacralizzazione ed emisacralizzazione, spondilolistesi degenerativa).
    • Instabilità del segmento spinale valutata tramite radiografia dimanica della colonna (RX)
    • Sindrome delle faccette articolari valutata con MRI (iperintensità e ipertrofia delle faccette articolari nelle immagini pesate in T2).
    • Pazienti che prima della visita di screening, hanno assunto:
    - Terapia con corticosteroidi orali nei tre mesi precedenti il trattamento,
    - Infusione intramuscolare, intravenosa o epidurale di corticosteroidi nei tre mesi precedenti il trattamento.
    • Presenza di un 4° livello con IDD sintomatico, (Grado 3-4 secondo Pfirrmann, grado 3-7 secondo Griffith) a livello della colonna vertebrale.
    • Stenosi del canale spinale (Schizas score > B).
    • Storia clinica di infezioni spinali.
    • Ernia lombare del disco e sciatica.
    • Anomalia dei dischi terminali, come ernie di Schmorl.
    • Precedenti iniezioni a livello del disco o precedente intervento alla colonna spinale.
    • IDD con modifiche Modic II e III valutate con le immagini ottenute da MRI.
    • Pazienti non idonei per la chirurgia ai dischi intervertebrali.
    • Pazienti che presentano il rischio di incorrere in interventi chirurgici nei 6 mesi successi all’inclusione nello studio.
    • Pazienti che abbiano installato un dispositivo/i per infusione locale di corticosteroidi.
    • Pazienti obesi con un indice di massa corporea (BMI espresso come peso Kg/m2) maggiore di 35 (grado di obesità II).
    • Soggetti che partecipano ad un altro studio clinico o in trattamento con un altro medicinale sperimentale nei 30 giorni precedenti all’inclusione nello studio.
    • Esami del sangue anomali: valori epatici (alanina transferasi [ALT] e / o aspartato aminotransferasi [AST] > 1,5 oltre i limiti della norma [ULN],
    • disturbi renali, pancreatici o biliari, disordini della coagulazione, anemia e conta delle piastrine < 100 x 109/L.
    • Donne in gravidanza o in allattamento, o donne in pre-menopausa che non usano un metodo contraccettivo precauzionale accettabile, non sono eleggibili per lo studio. La contraccezione dovrà essere mantenuta durante tutto il periodo di trattamento e fino al termine dello studio. Un test di gravidanza aggiuntivo sarà effettuato al termine dello studio. Ai pazienti è richiesto l’uso di metodi contraccettivi dall’inizio del trattamento e fino a 24 mesi dopo l’ultima dose del medicinale sperimentale.
    • In ogni caso di ritardo del periodo mestruale (oltre un intervallo di un mese tra le due mestruazioni), è fortemente raccomandato escludere la possibilità di un’eventuale gravidanza. La lista completa dei metodi contraccettivi è descritta nel foglio informativo per il paziente e nel paragrafo 6.5.
    • Positività sierologica per le seguenti infezioni: Sifilide, HIV, Epatite B o C
    • Non idoneità alla risonanza magnetica valutata dallo sperimentatore.
    • Intolleranza o allergia all'anestesia locale.
    • Qualsiasi storia clinica di cancro o malattia da immunodeficienza.
    • Precedente trapianto.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of intradiscal injection of autologous BM-MSC using the visual analog scale (VAS) and functional status assessed by the Oswestry disability index (ODI) after 24 months of treatment, defining responders in case of at least 40% improvement in VAS or ODI at month 24 compared to baseline.
    Valutare l'efficacia dell'iniezione intradiscale di cellule autologhe BM-MSC utilizzando la scala analogica visiva (VAS) e l'indice di disabilità Oswestry (ODI) per valutare lo stato funzionale dopo 24 mesi di trattamento, defininendo responsivi i pazienti che presentano un miglioramento di almeno il 40% in VAS o ODI al mese 24 rispetto al basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 months from treatment
    Dopo 24 mesi dal trattamento
    E.5.2Secondary end point(s)
    - To evaluate changes of the treated IVD induced by regenerative therapy by quantitative Magnetic Resonance Imaging (MRI) signal measurements in T2, T1spin/echo, and T1rho weighted images that allow a quantitative measure of the NP extracellular matrix.
    - To evaluate modification of disability (ODI) and quality of life (SF-36 scores) considered as continuos measures, between baseline and 1, 3, 6, 12 and 24 months.
    - Safety and tolerability will be evaluated by recording adverse events (AEs) and serious AEs (SAEs) throughout the study till 24 months. Number of participants with adverse events, the correlation of the AE to the IMP and their severity will be used as a measure of safety and tolerability.
    - To evaluate consumption of medications to relieve pain such as type and dose of analgesics will be evaluated. Paracetamol (acetaminophen) and levels 2 analgesics will be assessed throughout the study at each visit.
    - Valutare i cambiamenti dell' IVD trattati indotti dalla terapia rigenerativa mediante misure di Imaging quantitative del segnale di Risonanza Magnetica (MRI) nelle immagini T2, T1spin / echo e T1rho pesate che consentono una misura quantitativa della matrice extracellulare del Nucleo Polposo (NP).
    - Valutare la modifica della disabilità (ODI) e la qualità della vita (punteggi SF-36) considerati come misure continue, tra il basale ed i mesi 1, 3, 6, 12 e 24.
    - La sicurezza e la tollerabilità saranno valutate registrando eventi avversi (AE) e eventi avversi gravi (SAE) durante lo studio fino a 24 mesi. Il numero di partecipanti con eventi avversi, la correlazione dell'AE all'IMP e la loro gravità saranno usati come misura di sicurezza e tollerabilità.
    - Valutare il consumo di farmaci per alleviare il dolore come il tipo e la dose di analgesici. Paracetamolo (acetaminofene) e analgesici di livello 2 saranno valutati durante lo studio ad ogni visita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between baseline and 1,3,6,12 and 24 months.
    Tra il basale ed i mesi 1,3,6,12 e 24
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 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
    Gruppo di controllo con procedura "sham" con sola anestesia
    Control group with a sham procedure including local anesthesia
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    Last visit last subject
    Ultima visita dell'ultimo paziente
    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 months3
    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 months3
    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: 52
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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 continue to be followed according to normal care provided by good clinical practice.
    I pazienti continueranno ad essere seguiti secondo la normale attività assistenziale prevista dalla buona pratica clinica.
    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 Decision2019-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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