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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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).

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    Summary
    EudraCT Number:2021-006068-26
    Sponsor's Protocol Code Number:FJD-MEIC-21-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-24
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-006068-26
    A.3Full title of the trial
    CLINICAL TRIAL PHASE IIa TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TREATMENT WITH FAT-DERIVED MESENCHYMAL ALLOGENIC MESENCHYMAL TRONCAL CELLS IN PATIENTS WITH SINGLE INFLAMMATORY STENOSIS IN THE CONTEXT OF CROHN'S DISEASE.
    ENSAYO CLINICO EN FASE IIa PARA EVALUAR LA SEGURIDAD Y EFICACIA DEL TRATAMIENTO CON CELULAS TRONCALES ALOGENICAS MESENQUIMALES DERIVADAS DE LA GRASA EN PACIENTES CON ESTENOSIS INFLAMATORIA UNICA EN EL CONTEXTO DE LA ENFERMEDAD DE CROHN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate if the laparoscopic administration of cells derived from the fatty tissue can improve the inflammatory stenosis in patient with Crohn's disease.
    Ensayo clínico para evaluar si la administración por laparoscopia de células derivadas del tejido graso puede mejorar la estenosis inflamatoria en pacientes con enfermedad de Crohn.
    A.3.2Name or abbreviated title of the trial where available
    FJD-MEIC-21-01
    A.4.1Sponsor's protocol code numberFJD-MEIC-21-01
    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 SponsorFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    B.1.3.4CountrySpain
    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 supportFundación Jiménez Díaz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    B.5.2Functional name of contact pointCLINICAL RESEARCH UNIT
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Reyes Católicos 2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number00349155048003214
    B.5.5Fax number0034915505353
    B.5.6E-mailmireia.arcas@fjd.es
    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 nameallogenic mesenchymal stem cell isolated from adipose tissue
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntestinal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.3Other descriptive nameALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
    D.3.9.4EV Substance CodeSUB181445
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Inflammatory stenosis in patient with Crohn's disease.
    Estenosis inflamatoria en pacientes con enfermedad de Crohn.
    E.1.1.1Medical condition in easily understood language
    Intestinal inflamatory constriction in patients with Crohn's disease.
    Estrechamiento por inflamación intestinal en pacientes con enfermedad de Crohn.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 evaluate the feasibility and safety of laparoscopic administration of allogeneic adMSCs for the treatment of patients with inflammatory intestinal stenosis associated with Crohn's disease.
    Evaluar la factibilidad y seguridad de la administración de adMSCs alogénicas por vía laparoscópica para el tratamiento de pacientes con estenosis inflamatorias intestinales asociadas a la Enfermedad de Crohn.
    E.2.2Secondary objectives of the trial
    To evaluate the preliminary efficacy of the treatment.
    To evaluate changes in the quality of life of treated patients using the IBDQ32 questionnaire.
    Evaluar la eficacia preliminar del tratamiento.
    Evaluar los cambios en la calidad de vida de los pacientes tratados mediante el cuestionario de IBDQ32.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who agree to participate and agree to give their written consent. 2.
    2. Patients over 18 years of age and under 75 years of age.
    3. With Crohn's disease diagnosed at least 6 months earlier who meet clinical, endoscopic, histological and/or radiological criteria.
    4. Presence of a single inflammatory stenotic lesion in the small bowel or ileocolic area with a maximum length of 5 cm, demonstrated by enteroresonance, producing episodes of intestinal occlusion/subocclusion. Other inflammatory lesions are acceptable, but only one should be identified as the obvious cause of the occlusion/subocclusion.
    5. Patients treated with at least one biologic drug and with inadequate response to maintenance doses and prior to intensification (either dose, interval or change/addition of another drug):
    a. anti-TNF (for at least 14 weeks, which includes induction and/or maintenance doses): Infliximab, Adalimumab, Certolizumab.
    b. Anti-integrin(at least for 14 weeks, which includes induction and/or maintenance doses): Vedolizumab
    c. Anti-IL-12/23(at least for 16 weeks, which includes induction and/or maintenance doses): Ustekinumab
    6. Women of childbearing age must have a negative pregnancy test at screening and agree to use effective contraceptive measures for the duration of study participation*.
    1. Pacientes que aceptan participar y estén de acuerdo con dar su consentimiento por escrito.
    2. Pacientes mayores de 18 años y menores de 75 años
    3. Con enfermedad de Crohn diagnosticada al menos 6 meses antes que cumplan criterios clínicos, endoscópicos, histológicos y/o radiológicos.
    4. Presencia de lesión estenótica inflamatoria única en el intestino delgado o área ileocolica con una longitud máxima de 5 cm, demostrada mediante enteroresonancia, que produzca episodios de oclusión/suboclusión intestinal. Se admite que existan otras lesiones inflamatorias, pero solo una debe ser identificada como causa evidente de la oclusión/suboclusión.
    5. Pacientes tratados al menos con un fármaco biológico y con inadecuada respuesta a dosis de mantenimiento y antes de la intensificación (ya sea de dosis, de intervalo o cambio/adición de otro medicamento):
    a. antiTNF (al menos durante 14 semanas, que incluye dosis de inducción y/o mantenimiento): Infliximab, Adalimumab, Certolizumab
    b. Anti-integrina(al menos durante 14 semanas, que incluye dosis de inducción y/o mantenimiento): Vedolizumab
    c. Anti-IL-12/23(al menos durante 16 semanas, que incluye dosis de inducción y/o mantenimiento): Ustekinumab
    6. Las mujeres en edad fértil deben presentar un test de embarazo negativo en el período de selección y comprometerse a usar medidas anticonceptivas eficaces durante el tiempo que dure su participación en el estudio*
    E.4Principal exclusion criteria
    1. Intra-abdominal abscesses larger than 3 cm not drained (surgically, by interventional radiology) or not treated with antibiotics. Patients may be included once the abscess has been drained (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
    2. Severe intestinal obstruction that requires urgent surgery
    3. Active outbreak of Crohn's disease requiring medical treatment, defined as abdominal pain, fever, bloody diarrhea and CRP greater than 10. The patient may be included once the condition has resolved, when the patient is on maintenance medication.
    4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
    5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease.
    6. Patients with primary sclerosing cholangitis.
    7. Patients with known congenital or acquired immunodeficiency, including HIV.
    8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
    9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia) or receive contrast with gadolinium.
    10. Patients unwilling or unable to comply with study procedures.
    11. Patients who are receiving, or have received any investigational medication in the 3 months prior to the screening period.
    12. Major surgery or severe trauma in the previous 6 months.
    13. Pregnant or lactating women.
    14. Patients who have contraindications for general anesthesia, locoregional (depending on the type of anesthesia required) or laparoscopy1. Intra-abdominal abscesses larger than 3 cm not drained (surgically, by interventional radiology) or not treated with antibiotics. Patients may be included once the abscess has been drained (without the need to wait) or if they have received antibiotic treatment, once improvement has been confirmed with imaging tests.
    2. Severe intestinal obstruction that requires urgent surgery
    3. Active outbreak of Crohn's disease requiring medical treatment, defined as abdominal pain, fever, bloody diarrhea and CRP greater than 10. The patient may be included once the condition has resolved, when the patient is on maintenance medication.
    4. History of previous invasive neoplasia in the last 5 years. Patients with completely resected basal cell carcinoma of the skin may be included
    5. History in the last 6 months of severe, progressive or uncontrolled hepatic, hematological, gastrointestinal, renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease.
    6. Patients with primary sclerosing cholangitis.
    7. Patients with known congenital or acquired immunodeficiency, including HIV.
    8. Known allergy or hypersensitivity to penicillin or aminoglycosides; DMEN (dulbecco modified eagle's medium), bovine serum, local anesthetic or gadolinium.
    9. Contraindication to perform MRI (pacemaker, hip replacement or severe claustrophobia) or receive contrast with gadolinium.
    10. Patients unwilling or unable to comply with study procedures.
    11. Patients who are receiving, or have received any investigational medication in the 3 months prior to the screening period.
    12. Major surgery or severe trauma in the previous 6 months.
    13. Pregnant or lactating women.
    14. Patients who have contraindications for general anesthesia, locoregional (depending on the type of anesthesia required) or laparoscopy
    1. Abscesos intraabdominales mayores de 3 cm no drenados (quirúrgicamente, por radiología intervencionista) o no tratados con antibióticos. Se podrán incluir pacientes una vez drenado el absceso (sin necesidad de esperar) o si ha recibido tratamiento antibiótico, una vez confirmada la mejoría con prueba de imagen.
    2. Cuadro de obstrucción intestinal severa que requiera cirugía urgente
    3. Brote activo por enfermedad de Crohn que requiera tratamiento médico, definido como dolor abdominal, fiebre, diarrea sanguinolenta y PCR mayor de 10. Se podrá incluir al paciente una vez resuelto el cuadro, cuando el paciente se encuentre con medicación de mantenimiento.
    4. Historia de neoplasia invasiva previa en los últimos 5 años. Pacientes con carcinoma de células basal de la piel completamente resecado pueden ser incluidos
    5. Historia en los últimos 6 meses de enfermedad severa, progresiva o incontrolada hepática, hematológica, gastrointestinal, renal, endocrina, pulmonar, cardiaca, neurológica o psiquiátrica.
    6. Pacientes con colangitis esclerosante primaria.
    7. Pacientes con inmunodeficiencia congénita o adquirida conocidas, incluido VIH.
    8. Alergia o hipersensibilidad conocida a penicilina o aminoglucósidos; DMEN (dulbecco modified eagle´s medium), serum bovino, anestésico local o gadolinium.
    9. Contraindicación para realizar RMN (marcapasos, prótesis de cadera o claustrofobia severa) o recibir contraste con gadolinio.
    10. Pacientes que no quieran o no puedan cumplir con los procedimientos del estudio.
    11. Pacientes que estén recibiendo, o hayan recibido cualquier medicamento en investigación en los 3 meses previos al periodo de selección.
    12. Cirugía mayor o trauma severo en los 6 meses previos.
    13. Mujeres embarazadas o en periodo de lactancia.
    14. Pacientes que tengan contraindicación para anestesia general, locorregional (en función del tipo de anestesia que se precise) o realización de laparoscopia
    E.5 End points
    E.5.1Primary end point(s)
    - Complications during anesthesia: (depending on the type of anesthesia)

    - Complications derived from the treatment administration procedure
    o Associated with laparoscopy
    o Associated with injection into perilesional fat
    o Associated with the investigational drug
    - Complicaciones durante la anestesia: (en función del tipo de anestesia)

    - Complicaciones derivadas del procedimiento de administración del tratamiento
    o Asociadas a la laparoscopia
    o Asociadas a la inyección en la grasa perilesional
    o Asociadas al medicamento en investigación
    E.5.1.1Timepoint(s) of evaluation of this end point
    VISIT 0 TO VISIT 6
    VISITA 0 A VISITA 6
    E.5.2Secondary end point(s)
    - To evaluate the change in the length of the stenosis with respect to the baseline in the enteroMRI
    - To assess the change in the CDAI questionnaire score from baseline at 6, 12, 18, 24, 36 and 52 weeks
    - To assess the change in score from baseline on the IBDQ32 questionnaire at 24 and 52 weeks of treatment
    - To describe the number of patients with an obstructive episode who required resection surgery during the study period.
    a. Evaluar el cambio en la longitud de la estenosis respecto del basal en la enteroRMN
    b. Evaluar el cambio en la puntuación del cuestionario CDAI respecto del basal a las 6, 12, 18, 24, 36 y 52 semanas
    c. Evaluar el cambio en la puntuación respecto del basal en el cuestionario de IBDQ32 a las 24 y 52 semanas del tratamiento
    d. Describir el número de pacientes con episodio obstructivo que hayan requerido una cirugía de resección durante el periodo del estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12, 18, 24, 36 and 52 weeks
    6, 12, 18, 24, 36 y 52 semanas
    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 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 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
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    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. Patients will be managed according to local standard of care after the end of the trial.
    Al finalizar el estudio, los pacientes continuarán recibiendo el tratamiento a criterio médico de acuerdo a la práctica clínica habitual
    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 Spanish Clinical Research Network
    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 Decision2022-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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