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    Summary
    EudraCT Number:2020-005717-40
    Sponsor's Protocol Code Number:2001-FIVI-002-IC
    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:2021-02-09
    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 number2020-005717-40
    A.3Full title of the trial
    Umbilical cord plasma for treating endometrial pathologies (thin endometrium / Ash erman’s syndrome/ endometria atrophy)
    Plasma rico en plaquetas procedente de cordón umbilical para el tratamiento de patologías endometriales (endometrio fino/ Síndrome de Asherman/ Atrofia endometrial): un estudio piloto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Umbilical cord plasma for treating endometrial pathologies (thin endometrium / Ash erman’s syndrome/ endometria atrophy)
    Plasma rico en plaquetas procedente de cordón umbilical para el tratamiento de patologías endometriales (endometrio fino/ Síndrome de Asherman/ Atrofia endometrial): un estudio piloto.
    A.3.2Name or abbreviated title of the trial where available
    hSCU-PRP
    A.4.1Sponsor's protocol code number2001-FIVI-002-IC
    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 SponsorIVI Foundation
    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 supportIVI Foundation
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVI Foundation
    B.5.2Functional name of contact pointDavinia Oltra Noguera
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Fernando Abril Martorell, 106, - Biopolo, Torre A, Planta 1ª
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.6E-maildavinia.oltra@ivirma.com
    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 namePlatelet-rich plasma from umbilical cord.
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNplatelet rich plasma, allogenic
    D.3.9.3Other descriptive nameHUMAN PLATELET, ALLOGENIC
    D.3.9.4EV Substance CodeSUB25592
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 6
    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) No
    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 Yes
    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
    Endometrial pathologies (Thin endometrium/ Asherman's syndrome/ Endometrial atrophy)
    Patologías endometriales (endometrio fino/ Síndrome de Asherman/ Atrofia endometrial)
    E.1.1.1Medical condition in easily understood language
    Endometrial pathologies (Thin endometrium/ Asherman's syndrome/ Endometrial atrophy)
    Patologías endometriales (endometrio fino/ Síndrome de Asherman/ Atrofia endometrial)
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study of endometrial regeneration and/or improvement, in the form of tissue thickening, in patients with endometrial pathologies
    (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet-rich plasma from the umbilical cord.
    Estudio de la regeneración y/o mejora endometrial, en forma de engrosamiento del tejido, en pacientes con patologías endometriales (endometrio fino/Síndrome de Asherman/Atrofia endometrial) tratadas con plasma rico en plaquetas procedentes de cordón umbilical.
    E.2.2Secondary objectives of the trial
    Evaluation of the proof of concept in the 3 arms of the group of patients with premature ovarian failure (group A).
    Study of the rates of implantation, pregnancy, abortion and live newborn after injection of the investigational drug (platelet-rich plasma from umbilical cord) in the group of patients with endometrial pathology (group B).
    Evaluation at the genetic and protein level of the endometrial biopsies collected from both groups (A and B).
    Study of the molecular composition of the different plasma fractions obtained from the collected umbilical cord samples
    Adverse events collection
    Evaluación de la prueba de concepto en los 3 brazos del grupo de pacientes con insuficiencia ovárica prematura (grupo A).
    Estudio de las tasas de implantación, embarazo, aborto y recién nacido vivo tras la inyección del medicamento en investigación (plasma rico en plaquetas procedente de cordón umbilical) en el grupo de pacientes con patología endometrial (grupo B).
    Evaluación a nivel génico y proteico de las biopsias endometriales recolectadas
    de ambos grupos (A y B).
    Recogida de eventos adversos
    Estudio de la composición molecular de las distintas fracciones de plasma obtenidas a partir de las muestras de cordón umbilical recolectadas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Umbilical cord blood donors: information and informed consent of the parent(s), umbilical cord blood from live births in the obstetrics and gynaecology department of the HUP La Fe; the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product.
    Patients group A: information and signed informed consent; woman, acting voluntarily, aged between 18 and 48 at the time of recruitment; body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2; patients with premature ovarian failure (amenorrhea before age 40 and FSH > 40 IU/L).
    Group B patients: information and signed informed consent; female, acting voluntarily, aged between 18 and 48 years at the time of recruitment; body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2; patients undergoing a cycle of assisted reproduction; endometrial thickness < 5mm despite the administration of oestrogens for more than 10 days and/or evidence of Asherman's Syndrome.
    Donantes de sangre cordón umbilical: información y consentimiento informado del/ los progenitores, sangre de cordón umbilical procedente de partos de recién nacidos vivos en el servicio de Ginecología y Obstetricia del HUP La Fe; se seguirá el mismo criterio de recogida de cordón umbilical que el estandarizado en el HUP La Fe para la donación de este producto biológico.
    Pacientes grupo A: información y consentimiento informado firmado; mujer, actuando voluntariamente, con edad comprendida entre los 18 y los 48 años en el momento del reclutamiento; índice de masa corporal (IMC): ≥ 18 kg/m2 y ≤ 35 kg/m2; pacientes con insuficiencia ovárica prematura (amenorrea previa a los 40 años y FSH > 40 IU/L).
    Pacientes grupo B: información y consentimiento informado firmado; mujer, actuando voluntariamente, con edad comprendida entre los 18 y los 48 años en el momento del reclutamiento; índice de masa corporal (IMC): ≥ 18 kg/m2 y ≤ 35 kg/m2; pacientes sometidas a un ciclo reproducción asistida; Grosor endometrial < 5mm a pesar de la administración de estrógenos durante más de 10 días y/o evidencias del Síndrome de Asherman.
    E.4Principal exclusion criteria
    Umbilical cord blood donors: the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product.
    The exclusion criteria will be the same for patient groups A and B: active genital infection proven at the time of recruitment; chronic endometritis; known endometrial pathology; psychological disorder that may make it difficult to follow up the study; positive results after serological analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis); presenting any syndrome or condition that, in the view of the principal investigator, could pose a risk to the study or to the patient; any significant clinical abnormality detected during the recruitment process; simultaneous participation in another study.
    The study will be carried out in the context of a clinical trial that may affect the objectives of the present study or after participation in the same study.
    Donantes de sangre de cordón umbilical: se seguirá el mismo criterio de recogida de cordón umbilical que el estandarizado en el HUP La Fe para la donación de este producto biológico.
    Los criterios de exclusión serán idénticos los grupos de pacientes A y B: infección genital activa probada en el momento del reclutamiento; endometritis crónica; patología endometrial conocida; desorden psíquico que pueda dificultar el seguimiento del estudio; resultados positivos tras el análisis serológico (HBsAg,
    HBcAb, VHC, VIH1, VIH2, sífilis); presentar cualquier síndrome o condición que, bajo el punto de vista de investigador principal, pudiera suponer un riesgo para el estudio o para la paciente; cualquier anomalía clínica significante detectada durante el proceso de reclutamiento; participación simultánea en otro estudio
    clínico que pueda afectar los objetivos del presente estudio o previa participación en este mismo estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Increase in endometrial thickness after application of PRP treatment, calculated as the difference between the endometrium after application of the treatment and the thickness of the patient's initial endometrium (in mm)
    Incremento del grosor endometrial tras la aplicación del tratamiento con PRP, calculado como la diferencia entre el endometrio tras la aplicación del tratamiento y el grosor del endometrio inicial de la paciente (en mm).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After application of PRP treatment
    Tras la aplicación del tratamiento con PRP
    E.5.2Secondary end point(s)
    Proof of concept.
    Implementation rate.
    Pregnancy rate.
    Abortion rate.
    Live birth rate.
    Evaluation at the genetic and protein level of the endometrial biopsies collected from both groups (A and B).
    Study of the molecular composition of the different plasma fractions obtained from the collected umbilical cord samples
    Adverse events collection
    Prueba de concepto.
    Tasa de implantación.
    Tasa de embarazo.
    Tasa de aborto.
    Tasa de recién nacido vivo.
    Evaluación a nivel genético y proteínico de las biopsias del endometrio recogidas de ambos grupos (A y B).
    Estudio de la composición molecular de las diferentes fracciones plasmáticas obtenidas de las muestras de cordón umbilical recogidas
    Colección de eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Proof of concept._Comparisons of endometrial thickness growth before and after PRP treatment, according to subgroups (grupo A) at the end of study

    Study of the rates of implantation, pregnancy, abortion and live newborn after injection of the investigational drug (platelet-rich plasma from umbilical cord) in the group of patients with endometrial pathology (group B), will be analized at the end of the study.

    Composition molecular of the plasma fractions of the PRP samples of the umbilical cord used, Protein and genetic pattern of the collected endometrial biopsies before and after applying the PRP treatment, will be analysed at the end of the study.

    Adverse effects, during all study.
    Prueba de concepto. Se comparará el crecimiento del grosor del endometrio antes y después del tratamiento con PRP, según los subgrupos (grupo A)

    El estudio de las tasas de implantación, embarazo, aborto y recién nacidos vivos después de la inyección del medicamento en investigación (plasma rico en plaquetas del cordón umbilical) en el grupo de pacientes con patología endometrial (grupo B), se analizará al final del estudio.


    La composición molecular de las fracciones plasmáticas de las muestras de PRP del cordón umbilical utilizadas, el patrón genético y de proteínas de las biopsias endometriales recogidas antes y después de aplicar el tratamiento de PRP, se analizará al final del estudio.

    Efectos adversos, durante todo el estudio.
    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 Yes
    E.8.1.7.1Other trial design description
    grupo A serán asignados al azar a tres sub-brazos, prueba de concepto, con endometrio sano
    group A patients will be randomised to three sub-arms, proof of concept, with healthy endometrium
    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
    Las pacientes del grupo B serán su propio control y las del grupo A se randomizarán a tres subgrupos
    Group B patients will be their own control and group A patients will be randomised to three sub-arms
    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 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 Patient
    Ultima visita último paciente
    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
    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: 45
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state45
    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 treatment of the condition
    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 Decision2021-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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