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    Summary
    EudraCT Number:2014-001402-18
    Sponsor's Protocol Code Number:CIR-MSC-2014-01
    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:2014-10-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-001402-18
    A.3Full title of the trial
    CD133 + CELL INFUSION IN PATIENTS WITH COLORECTAL LIVER ORIGIN METASTASES GOING TO BE SUBMITTED TO A MAJOR LIVER RESECTION
    INFUSIÓN DE CELULAS CD133+, EN PACIENTES CON METÁSTASIS HEPÁTICAS DE ORIGEN COLORRECTAL QUE VAN A SER SOMETIDOS A UNA RESECCIÓN HEPÁTICA MAYOR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CD133 + CELL INFUSION IN PATIENTS WITH COLORECTAL LIVER ORIGIN METASTASES GOING TO BE SUBMITTED TO A MAJOR LIVER RESECTION
    INFUSIÓN DE CELULAS CD133+, EN PACIENTES CON METÁSTASIS HEPÁTICAS DE ORIGEN COLORRECTAL QUE VAN A SER SOMETIDOS A UNA RESECCIÓN HEPÁTICA MAYOR
    A.3.2Name or abbreviated title of the trial where available
    CIRCOL
    CIRCOL
    A.4.1Sponsor's protocol code numberCIR-MSC-2014-01
    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 SponsorALEJANDRA GARCIA BOTELLA
    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 Clínico San Carlos
    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 Clínico San Carlos
    B.5.2Functional name of contact pointUICEC
    B.5.3 Address:
    B.5.3.1Street AddressPROFESOR MARTÍN LAGOS S/N
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number00349133037933793
    B.5.5Fax number00349133035153515
    B.5.6E-mailfibucicec.hcsc@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 nameSTEM CELLS PERIPHERAL BLOOD ENDOTHELIAL AUTOLOGOUS NOT EXPANDED
    D.3.2Product code CD133+
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous peripheral blood stem adult cells not expanded CD 133+
    D.3.9.1CAS number MASKED
    D.3.9.3Other descriptive nameCORD BLOOD-DERIVED, EX VIVO NON-EXPANDED CD133- CELLS
    D.3.9.4EV Substance CodeSUB130958
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    patients with liver metastases from colorectal carcinoma
    pacientes con metástasis hepáticas de carcinoma colorrectal
    E.1.1.1Medical condition in easily understood language
    patients with liver metastases from colorectal carcinoma
    pacientes con metástasis hepáticas de carcinoma colorrectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the effectiveness of preoperative portal embolization with administration of single liver CD133 + cells mobilized with G-CSF compared to portal embolization
    Evaluar la efectividad de la embolización portal preoperatoria junto a la administración al hígado de células CD133+ movilizadas con G-CSF, frente a la embolización portal sola
    E.2.2Secondary objectives of the trial
    Evaluate the Safety of experimental treatment
    Compare final degree of hypertrophy after surgery and how the biochemical parameters of liver function are modified in both groups.
    Assessment of different morphological changes that occur in the same following administration of G-CSF
    Compare the postoperative morbidity between groups.
    Analyze the event-free survival (death from any cause) in groups.
    Evaluar la Seguridad del tratamiento experimental.
    Comparar cual es el grado de hipertrofia final tras la cirugía y cómo se modifican los parámetros bioquímicos de funcionalidad hepática, en ambos grupos.
    Estudio anatomopatológico del hígado, evaluación de los diferentes cambios morfológicos que se producen en el mismo tras la administración de G-CSF, tras embolización portal y en el resto.
    Comparar la morbilidad postoperatoria entre los diferentes grupos.
    Analizar la supervivencia libre de eventos (muerte de cualquier causa) en los grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age between 18 and ? 80 years old
    2. Quality of Life Scale ECOG (Eastern Cooperative Oncology Group) ?2
    3. Potential childbearing women must follow contraception methods recomended by Clinical Trial Facilitation Group (CTFG) .
    4. patients with liver metastases from colorectal carcinoma, which have insufficient liver remnant to make a major hepatectomy. This volume is calculated by imaging with multidetector CT of 64 channels.
    - patients who received preoperative chemotherapy and estimated residual liver volume <40%.
    - Patients with preserved liver function who have not received chemotherapy and calculated residual volume <30%
    5. Signing the informed consent.
    1. Hombres y mujeres con edad ? 18 años y ? 80
    2. Escala de calidad de vida ECOG (Eastern Cooperative Oncology Group) ?2
    3. Mujeres en edad fértil que sigan métodos anticonceptivos recomendados por el Clinical Trial Facilitation Group (CTFG).
    4. Pacientes con metástasis hepáticas de carcinoma colorrectal, que no tengan remanente hepático suficiente para poder realizar una hepatectomía mayor. Este volumen se calculará mediante adquisición de imágenes con TAC multidetector de 64 canales.
    ? En el caso de los pacientes que han recibido quimioterapia preoperatorio, el volumen hepático estimado residual, para incluirlos en el estudio, será <40%.
    ? Los pacientes que tengan una función hepática conservada y que no hayan recibido quimioterapia, el volumen calculado residual, para incluirlos en el estudio, será <30%.
    5. Haber firmado el consentimiento informado.
    E.4Principal exclusion criteria
    1. Pregnancy or breastfeeding
    2. Any condition that, according to the researchers, involving subjecting the patient to an unjustifiable risk.
    3. Severe comorbidities: ASA ? 4.
    4. Changes in the blood count and morphological alterations, hematologist accounted for prior to the administration of G-CSF.
    5. Liver function: Child ? B7, INR ? 2 in anticoagulated patients, in patients anticoagulated values prior to the surgery reversed.
    6. Participation in other research studies in the last 12 months.
    7. Patients on chemotherapy, can not be administered G-CSF until they have not spent 48 hours after the last dose of chemotherapy. Patients who received Avastin must wait 30 days from the last administration.
    8. Aspects that prevent the patient cannot be part of the study such as understanding the rules thereof, follow the instructions to be given, or other aspects deemed appropriate.
    1. Embarazo o periodo de lactancia.
    2. Cualquier condición que a juicio de los investigadores sometería al paciente a un riesgo injustificable.
    3. Comorbilidades severas: ASA ? 4.
    4. Alteraciones en el hemograma y alteraciones morfológicas, valoradas por hematólogo previa a la administración de G-CSF.
    5. Función hepática: Child ? B7, INR ? 2 en pacientes no anticoagulados, en los pacientes anticoagulados se revertirán los valores, previo a la cirugía.
    6. Participación en otros estudios de investigación en los últimos 12 meses.
    7. Pacientes en tratamiento quimioterápico, no se podrá administrar G-CSF hasta que no hayan pasado 48 horas desde la última administración de la quimioterapia. Los pacientes que hayan recibido Bevacizumab deberán esperar 30 días desde la última administración.
    8. Adicionalmente todos aquellos aspectos que impidan al paciente formar parte del estudio, comprender las normas del mismo, seguir las instrucciones que se le den, u otros aspectos que se consideren convenientes.
    convenientes.
    E.5 End points
    E.5.1Primary end point(s)
    Liver volumes (in cubic centimeters, cc)
    Volúmenes hepáticos (en centímetros cúbicos, cc)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before surgery, after embolization site after surgery.
    The first control after PVE was performed at 2 weeks and repeated every 2 weeks until surgery.
    After surgery monthly until month 24 (1,3,6,12,18,24).
    Antes de la cirugía, tras la embolización portal y después de la cirugía.
    El primer control tras la PVE se realizará a las 2 semanas y se repetirá cada 2 semanas hasta cirugía.
    Tras la cirugía mensualmente hasta mes 24 (1,3,6,12,18,24).
    E.5.2Secondary end point(s)
    Adverse events related to infusion of CD133 + cells.
    Analytical Parameters: Total bilirubin, albumin, AST, ALT, alkaline phosphatase, GGT, WBC, hemoglobin, hematocrit, platelets, INR, prothrombin activity and clinical parameters: presence or absence of ascites and / or hepatic encephalopathy.
    Morphological changes of the liver
    Postoperative morbidity.
    Death from any cause.
    Acontecimientos y efectos adversos relacionados con la infusión de células CD133+.
    Parámetros analíticos: Bilirrubina total, Albúmina, AST, ALT, Fosfatasa alcalina, GGT, leucocitos, hemoglobina, hematocrito, plaquetas, INR, actividad de protrombina y parámetros clínicos: presencia o no, de ascitis y/o encefalopatía hepática.
    Cambios morfológicos del hígado
    Morbilidad postoperatoria.
    Muerte de cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Antes de la cirugía, tras la embolización portal y después de la cirugía.
    El primer control tras la PVE se realizará a las 2 semanas y se repetirá cada 2 semanas hasta cirugía.
    Tras la cirugía mensualmente hasta mes 24 (1,3,6,12,18,24).
    Before surgery, after portal embolization after surgery.
    The first control after portal embolization was performed at 2 weeks and repeated every 2 weeks until surgery.
    After surgery monthly until month 24 (1,3,6,12,18,24).
    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 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 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 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 Yes
    E.8.2.3.1Comparator description
    solo embolización portal
    only portal embolization
    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.8.5The 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
    ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 20
    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 No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    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
    ninguno
    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 Decision2015-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-31
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