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    Summary
    EudraCT Number:2012-001178-28
    Sponsor's Protocol Code Number:FISPAC-2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-12
    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 number2012-001178-28
    A.3Full title of the trial
    Multicentre, randomized, comparative and Add-on, in two parallel groups to assess the efficacy and safety of autologous mesenchymal stem cells derived from expanded adipose tissue (ASC) for the treatment of complex perianal disease in patients without disease inflammatory bowel disease.
    Ensayo clínico multicéntrico, aleatorizado, comparativo y Add-on, en dos grupos paralelos para evaluar la eficacia y seguridad de las células troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC), para el tratamiento de la patología fistulosa perianal compleja en pacientes sin enfermedad inflamatoria intestinal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ensayo en el que se evalúa la eficacia y seguridad de la utilización de células madre autólogas para tratar la patología perianal en pacientes que no tienen enfermedad inflamatoria intestinal
    A.4.1Sponsor's protocol code numberFISPAC-2011
    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 SponsorFundación para la Investigación Biomédica del Hospital Universitario La Paz
    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 para la Investigación Biomédica del Hospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital Universitario La Paz
    B.5.2Functional name of contact pointMariano García Arranz
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de La Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34912071022
    B.5.5Fax number+34912071512
    B.5.6E-mailmgarciaa.hulp@salud.madrid.org
    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 nameCélulas troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCélulas troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000000
    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) Yes
    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 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
    Local treatment in complex perianal fistulas in patients without inflammatory bowel disease
    Tratamiento local de fístulas perianal compleja en pacientes sin enfermedad inflamatoria intestinal.
    E.1.1.1Medical condition in easily understood language
    Pacientes sin enfermedad inflamatoria intestinal que tengan fístula perianal
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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
    Compare the efficacy of autologous stem cells (ASC) plus fibrin glue versus fibrin glue for the closure of complex perianal fistulas not associated to inflammatory bowel disease. Fistula closure is defined as the absence of suppuration in the external orifice of the fistula and complete re-epithelialization of the external orifice en the clinic assesment.
    Comparar la eficacia de ASC más adhesivo de fibrina frente al adhesivo de fibrina solo para el cierre de las fístulas perianales complejas no asociadas a la enfermedad inflamatoria intestinal. Se define cierre de la fístula como ausencia de supuración por el orificio externo de la fístula y re-epitelización completa del orificio externo en la evaluación clínica.
    E.2.2Secondary objectives of the trial
    Evaluate the safety in patients treated with ASC plus fibrin glue versus patients treated with only fibrin glue
    Evaluate the evolution of the clinical complexity of the fistula in the patients treated
    Evaluate the quality of life for both treatment groups (SF-12 score)
    Assess the fecal incontinence degree in both groups of patients (Wexner score).
    Evaluate the value of NMR in the follow-up of these patients
    - Evaluar la seguridad en los pacientes tratados con ASC más adhesivo de fibrina frente a los pacientes tratados con adhesivo de fibrina.
    - Evaluar la evolución de la complejidad clínica de la fístula en los pacientes tratados.
    - Evaluar la calidad de vida de ambos grupos de tratamiento (SF-12 score).
    - Evaluar el grado de incontinencia fecal en ambos grupos de pacientes (WEXNER score).
    - Evaluar el valor de la RMN en el seguimiento de estos enfermos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent
    - Perianal complex fistula with criptoglandular origin, that means fistula with some of the following circumstances:
    _Some grade of fecal incontinence
    _ Extra-sphincter fistula
    _Supra-sphincter fistula
    _Trans-sphnicter fistula
    _Patients both sexs elder than 18 years old. Good clinical condition, according to the patient medical notes and physical examination.
    - Firma del consentimiento informado.
    - Fistula perianal compleja de origen criptoglandular. Entendiendo por tales a la fístula en el que se al menos una de las siguientes circunstancias
    o Algún grado de Incontinencia fecal asociada,
    o Las fístulas extraesfinterianas,
    o Las fístulas supraresfinterianas
    o Las fístulas transesfinterianas altas.
    - Pacientes de ambos sexos mayores de 18 años. Buen estado general de salud, de acuerdo con los datos de la historia clínica y la exploración física.
    E.4Principal exclusion criteria
    - Patient diagnosed with intestinal inflammatory disease.
    - Patients with abscess, unless a complete cleaning of the zone with drainage of the collections is done and the absence of abscess and other collections majors than 2 cm of maximum diameter is confirmed before initiating the treatment.
    - Antecedents of alcohol or other addictive substances abuse in the 6 months previous to the inclusion.
    - Malignant neoplasia, unless it is a skin basocelular or epidermoide carcinoma or antecedents of malignant tumors, unless they have been in remission phase during the 5 previous years.
    - Cardiopulmonary disease that, according to the investigator, is unstable or revista is sufficiently serious to discard the patient from the study.
    - Medical or psychiatric disease of any type that, according to the investigator, can suppose a reason for exclusion from the study.
    - Subjects with congenital or acquired immunodeficiencies. Hepatitis B and/or C or tuberculosis diagnosed during the inclusion
    - Greater surgery or serious traumatism of the patient in the previous semester.
    - Pregnant or breastfeeding women.
    - Adult women of childbearing age not using effective contraception during the trial.
    - Administration of any other drug in investigation at present or any time during the three months prior the recruitment for this trial.
    - Paciente diagnosticado con enfermedad inflamatoria intestinal
    - Sujetos con absceso, salvo que se efectúe una limpieza completa de la zona con drenaje de las colecciones y se confirme la ausencia de absceso y otras colecciones mayores de 2 cm de diámetro máximo antes de iniciar el tratamiento.
    - Antecedentes de abuso de alcohol o de otras sustancias adictivas en los 6 meses anteriores a la inclusión.
    - Neoplasia maligna, salvo que se trate de carcinoma basocelular o epidermoide de la piel o antecedentes de tumores malignos, salvo que se hayan encontrado en fase de remisión durante los 5 años anteriores.
    - Enfermedad cardiopulmonar que, en opinión del investigador, resulte inestable o revista la gravedad suficiente para descartar al paciente del estudio.
    - Enfermedad médica o psiquiátrica de cualquier tipo que, en opinión del investigador, pueda suponer un motivo de exclusión del estudio.
    - Sujetos con inmunodeficiencias congénitas o adquiridas. Hepatitis B y/o C o tuberculosis diagnosticada en el momento de la inclusión, treponema.
    - Cirugía mayor o traumatismo grave del sujeto en el semestre anterior.
    - Mujeres embarazadas o lactantes.
    - Mujeres adultas en edad fértil que no utilicen medios anticonceptivos eficaces durante el ensayo.
    - Administración de cualquier fármaco en investigación en el momento actual o tres meses antes del reclutamiento para este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Study efficacy and safety
    Eficacia y seguridad del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once patient received treatment, 16 weeks after the last implantation and after 9 months of follow up
    Se valorará una vez la paciente haya recibido el tratamiento, a las 16 semanas del último implante y a los 9 meses de seguimiento
    E.5.2Secondary end point(s)
    Evaluación de la calidad de vida de los pacientes yuna evaluación clínica del tratamiento

    Evaluación de recidiva: evaluación clínica
    Assesment of patient quality of life as well as a clinical assessment of treatment

    Assessment of recurrence: clinical assesment
    E.5.2.1Timepoint(s) of evaluation of this end point
    First one:
    After 16 weeks after last implantation.
    Second one:
    At 36 weeks after last implantation.
    Del primer objetivo secundario:
    Tras 16 semanas desde la última implantación

    Del segundo objetivo secundario:
    Después de 36 semanas tras la última implantación.
    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) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Pegamento de Fibrina
    Fibrin Glue
    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 concerned5
    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
    When a patient is withdraw from the study for any reason, this must be notified and the investigator will carry out every end of study procedures. Nevertheless, the patient will be asked to come to consultation at 16 weeks and nine months after the cell implantation to check if any adverse event has occurred.
    Cuando un paciente sea retirado del estudio, por cualquier causa, debe ser notificado y el investigador cumplimentará todos los procedimientos de fin del estudio. No obstante se solicitará al paciente que acuda a la consulta a la semana 16 y a los 9 meses posterior al implante celular para comprobar si ha ocurrido algún acontecimiento adverso.
    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 months0
    E.8.9.1In the Member State concerned 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: 80
    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 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 state80
    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)
    Normal practice
    Los de la práctica habitual
    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 Decision2012-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
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