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    Summary
    EudraCT Number:2021-001341-12
    Sponsor's Protocol Code Number:UV/AP/21
    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:2023-01-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001341-12
    A.3Full title of the trial
    Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrin-hyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
    Ensayo clínico Fase I/II, de prueba de concepto, multicéntrico, aleatorizado, controlado, para valorar factibilidad, seguridad e indicios de eficacia de la aplicación de células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas en matriz biológica de fibrina-ácido hialurónico, en el tratamiento de úlceras venosas de miembros inferiores.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial with adipose tissue stem cells on biological matrix for the treatment of venous ulcer of the lower limbs.
    Ensayo clínico con láminas de células madres de tejido adiposo para el tratamiento de úlceras venosas de miembros inferiores.
    A.3.2Name or abbreviated title of the trial where available
    Clinical trial with adipose tissue stem cells on biological matrix for the treatment of venous ulcer
    Ensayo clínico con láminas de células madres de tejido adiposo para el tratamiento de úlceras venosa
    A.4.1Sponsor's protocol code numberUV/AP/21
    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 SponsorRed Andaluza de Diseño y Traslación en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud M.P.
    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 Pública Andaluza Progreso y Salud M.P.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRed Andaluza de Diseño y Traslación en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud M.P.
    B.5.2Functional name of contact pointLourdes Rojas Alvarez-Ossorio
    B.5.3 Address:
    B.5.3.1Street AddressAmérico Vespucio 15, Edificio S-2; Parque científico y Tecnológico Cartuja
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41092
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955 890 107
    B.5.6E-mailLourdes.rojas.alvarez@juntadeandalucia.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 nameBioengineered Artificial Mesenchimal Sheet.
    D.3.2Product code BAMS
    D.3.4Pharmaceutical form Living tissue equivalent
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameAllogeneic adipose-derived mesenchymal stem cells expanded
    D.3.9.4EV Substance CodeSUB253387
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    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 No
    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
    Venous ulcer
    Úlcera venosa
    E.1.1.1Medical condition in easily understood language
    Venous ulcer
    Úlceras venosas
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10047259
    E.1.2Term Venous ulcer NOS
    E.1.2System Organ Class 100000004858
    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 of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
    To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to conventional treatment.
    Evaluar la factibilidad de la aplicación tópica de CMTAd en matriz biológica de fibrina-ácido hialurónico sobre úlceras venosas (UV).
    Examinar la seguridad de la administración cutánea de CMTAd en matriz biológica de fibrina-ácido hialurónico sobre UVs frente al tratamiento convencional.
    E.2.2Secondary objectives of the trial
    To determine the effect of the experimental treatment on wound closure time compared to the control group.
    To assess the effect of the experimental treatment on the healing evolution of the lesion, in terms of depth, size, type of edges, tissue and exudate compared to the control group.
    To assess the effect of the experimental treatment on the concentration of growth factors closely related to wound healing (IL-6, IFN-, TNF-, VEGF, HGF y TGF-β1) in the exudate of the lesion in on day 0 and day +28 compared to the control group and its possible relationship with the rest of the efficacy parameters.
    Evaluate the evolution of pain derived from the presence of UVs in the group treated with the PEI, in comparison with the control group.
    To determine the perceived quality of life after treatment with the experimental treatment compared to the control group.
    Determinar el efecto del tratamiento experimental sobre el tiempo de cierre de la herida en comparación con el grupo control.
    Valorar el efecto del tratamiento experimental sobre la evolución cicatrizal de la lesión, en términos de profundidad, dimensión, tipo de bordes, tejido y exudado en comparación con el grupo control.
    Valorar el efecto del tratamiento experimental sobre la concentración de factores de crecimiento estrechamente relacionados con la cicatrización de heridas (IL-6, IFN-, TNF-, VEGF, HGF y TGF-β1) en el exudado de la lesión en el día 0 y día +28 frente al grupo control y su posible relación con el resto de parámetros de eficacia.
    Evaluar la evolución del dolor derivado de la presencia de UVs en el grupo tratado con el PEI, en comparación con el grupo control.
    Determinar la calidad de vida percibida tras el tratamiento con el tratamiento experimental en comparación con el grupo control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signing of the informed consent (IC) after reading the patient information sheet.
    2. Over 18 years of both sexes.
    3. Active or recurrent venous ulcer (C6 according to the CEAC clinical classification, Annex 5)” in the lower extremity with an area between 5-10 cm2
    4. Grade III injury on the Widmer scale.
    5. Independence and/or availability to go to the referral center on an outpatient basis.
    6. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3
    1. Firma del consentimiento informado (CI) previa lectura de la hoja de información al paciente (HIP).
    2. Mayores de 18 años de ambos sexos.
    3. Úlcera venosa activa o recurrente (C6 de acuerdo con la clasificación clínica de la CEAC, Anexo 5)” en extremidad inferior con un área de entre 5-10 cm2
    4. Lesión Grado III en la escala de Widmer.
    5. Independencia y/o disponibilidad para acudir al centro de referencia de forma ambulatoria.
    6. Pulsos distales en miembros inferiores palpables (tibial y pedio). ITB entre 0,8 - 1,3
    E.4Principal exclusion criteria
    1. Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms. The following comorbidities will be allowed: peripheral vascular disease, coronary heart disease, chronic kidney disease, chronic liver disease, and arterial hypertension.
    2. Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5).
    3. Active neoplasia and/or being treated with cytostatics.
    4. Patients undergoing radiotherapy treatment in areas close to the lesion.
    5. Clinical signs of colonization or local infection of the lesion.
    6. Patients with more than one lesion compatible with UV in the same lower limb.
    7. Erysipelas.
    8. Infectious cellulite.
    9. Osteomyelitis.
    10. Lymphangitis.
    11. Chronic lymphedema.
    12. Therapy with corticosteroids or immunosuppressants.
    13. Venous ulcer grade I or II on the Widmer scale.
    14. Lesions close to possible or diagnosed cancerous lesions.
    15. Non-localized wounds in the lower extremities.
    16. Ongoing infection and/or sepsis.
    17. Critical ischemia in the lower limbs or other venous diseases of unknown origin.
    18. Immunocompromised patients.
    19. Dependent patients with severe mobility limitations.
    20. Dialysis patients.
    1. Cualquier patología para la cual el investigador considera que el vendaje compresivo está contraindicado y/o Trombosis venosa profunda (TVP) aguda previa, dentro de los primeros 10 días desde el inicio de los síntomas. Se permitirán las siguientes comorbilidades: enfermedad vascular periférica, enfermedad coronaria, enfermedad renal crónica, enfermedad hepática crónica e hipertensión arterial.
    2. Obesidad grado III con un índice de masa corporal (IMC) >40; o pacientes con peso insuficiente (IMC <18,5).
    3. Neoplasia activa y/o en tratamiento con citostáticos.
    4. Pacientes en tratamiento con radioterapia en zonas cercanas a la lesión.
    5. Signos clínicos de colonización o infección local de la lesión.
    6. Pacientes con más de una lesión compatible con UV en el mismo miembro inferior.
    7. Erisipela.
    8. Celulitis infecciosa.
    9. Osteomielitis.
    10. Linfangitis.
    11. Linfedema crónico.
    12. Terapia con corticoides o inmunosupresores.
    13. Úlcera venosa grado I o II en la escala de Widmer.
    14. Lesiones cercanas a lesiones cancerosas posibles o diagnosticadas.
    15. Heridas no localizadas en extremidades inferiores.
    16. Infección y/o sepsis en curso.
    17. Isquemia crítica en miembros inferiores u otras enfermedades venosas de origen desconocido.
    18. Pacientes inmunodeprimidos.
    19. Pacientes dependientes y con limitaciones severas de la movilidad.
    20. Pacientes en diálisis.
    21. Pacientes con talasemia.
    22. Insuficiencia cardiaca descompensada.
    23. Mujeres embarazadas y lactantes.
    E.5 End points
    E.5.1Primary end point(s)
    Feasibility: Defined as the possibility of completing the administration of the 4 doses of the investigational drug in at least 80% of the patients randomized to the treatment group.
    Safety: Incidence of AA, AAG, RA, as well as RAGI, during the entire intervention period, as well as the 12 months after completion of treatment.
    Factibilidad: Definida como la posibilidad de completar la administración de las 4 dosis del medicamento en Investigación en al menos el 80% de los pacientes aleatorizados al grupo tratamiento.
    Seguridad: Incidencia de AA, AAG, RA, así como RAGI, durante todo el periodo de intervención, así como los 12 meses posteriores a la finalización del tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end points will be evaluated throughout the development of the clinical trial
    Las variables serán evaluadas durante todo el desarrollo del ensayo clínico
    E.5.2Secondary end point(s)
    Of efficacy:
    The response will be analyzed through clinical and biological parameters
    Clinics:
    • Percentage of patients who achieve complete healing
    • Time elapsed (days) until wound closure, measured from the start of treatment to the absence of a solution of continuity
    • Percentage of patients presenting improvement in the total score and by items of the Resvech 2.0 scale
    • Percentage reduction in the extent of the wound (relative area measured with the Moleculight application)
    • Percentage of patients presenting a decrease in the VAS pain scale score
    • Percentage of patients who perceive an improvement in their quality of life according to the score obtained in the CIVIQ20
    Biological:
    • Evolution of the pattern of cytokines and growth factors obtained from the ulcer exudate samples.
    De eficacia:
    La respuesta se analizará a través de parámetros clínicos y biológicos
    Clínicos:
    • Porcentaje de pacientes que alcanzan la cicatrización completa.
    • Tiempo transcurrido (días) hasta el cierre de la herida, medido desde el inicio del tratamiento hasta la ausencia de solución de continuidad.
    • Porcentaje de pacientes que presentan mejoría en la puntuación total y por ítems de la escala Resvech 2.0.
    • Porcentaje de reducción de la extensión de la herida (área relativa medida con la aplicación Moleculight).
    • Porcentaje de pacientes que presentan una disminución de la puntuación de la escala de dolor EVA .
    • Porcentaje de pacientes que perciben mejoría en la calidad de vida de acuerdo a la puntuación obtenida en el CIVIQ20
    Biológicos:
    • Evolución del patrón de citoquinas y factores de crecimiento obtenidos de las muestras de exudado de la ulcera.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end points will be evaluated throughout the development of the clinical trial
    Las variables serán evaluadas durante todo el desarrollo del ensayo clínico
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I-II. Factibility, safety and efficacy
    Fase I-II. Factibilidad, seguridad y eficacia
    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 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
    Procedimiento de cura convencional de la úlcera
    Standard of care procedure
    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 concerned2
    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
    Last visit of the last subjet
    Última visita del último paciente incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    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
    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 Decision2023-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-20
    P. End of Trial
    P.End of Trial StatusOngoing
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