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    Summary
    EudraCT Number:2016-000240-34
    Sponsor's Protocol Code Number:REX-001-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2016-04-20
    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 number2016-000240-34
    A.3Full title of the trial
    The Efficacy and Safety of Intra-Arterial Administration of Rexmyelocel T to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus: A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial
    Eficacia y seguridad en la administración intraarterial de Rexmyelocel-T en el tratamiento de la isquemia crítica de extremidades inferiores en pacientes con diabetes mellitus: ensayo controlado con placebo, doble ciego, aleatorizado, multicéntrico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the efficacy and safety of a bone marrow cell preparation to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus.
    Un ensayo clínico para probar la eficacia y seguridad de una preparación de células de médula ósea para tratar la isquemia crítica de extremidades inferiores en sujetos con diabetes mellitus.
    A.4.1Sponsor's protocol code numberREX-001-004
    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 SponsorRexgenero Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRexgenero Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRexgenero Limited
    B.5.2Functional name of contact pointChief Operating Officer
    B.5.3 Address:
    B.5.3.1Street Address14 Basil Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW3 1AJ
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailedwin.wagena@rexgenero.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 nameRexmyelocel-T
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous adult non-expanded bone marrow mononuclear cells
    D.3.9.1CAS number mononuclear
    D.3.9.2Current sponsor codeRexmyelocel-T
    D.3.9.3Other descriptive namemononuclear cells
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms billion organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500000000 to 1000000000
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue engineered product; EMA/CAT/451233/2015
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntraarterial use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical Limb Ischemia in patients with Diabetes Mellitus
    Isquemia crítica de extremidades inferiores en pacientes con diabetes mellitus
    E.1.1.1Medical condition in easily understood language
    Severe obstruction of the arteries in patients with Diabetes Mellitus
    Obstrucción severa de las arterias en pacientes con Diabetes Mellitus
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10077142
    E.1.2Term Limb ischemia
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10058069
    E.1.2Term Critical limb ischemia
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10012601
    E.1.2Term Diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the efficacy and safety of a single intra-arterial administration of Rexmyelocel-T to treat critical limb ischemia (CLI) in subjects with diabetes mellitus (DM) by restoring blood flow, treating ulcers, improving mobility, and improving the quality of life (QOL).
    Confirmar la eficacia y la seguridad de una sola administración intraarterial de Rexmyelocel-T en el tratamiento de la isquemia crítica de extremidades inferiores en pacientes con diabetes mellitus (DM) restituyendo el flujo sanguíneo, tratando las úlceras, mejorando la movilidad y mejorando la calidad de vida (CdV).
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged ? 18 to ? 80 years.
    2. Diagnosis of Type I or II DM, established more than one year ago.
    3. Subjects with poor or no revascularization option (i.e., surgical or endovascular revascularization), in general classified as CLI Rutherford Category 4 or 5, including ankle systolic pressure < 70 mm Hg, or toe systolic pressure < 50 mm Hg or TcPO2 < 30 mm Hg.
    1.Edad ? 18 a ? 80 años.
    2.Diagnóstico de DM tipo 1 o 2, establecido hace más de un año.
    3.Sujetos con malas opciones de revascularización o sin opciones de revascularización (es decir, revascularización quirúrgica o endovascular), en general con isquemia crítica de extremidades inferiores de categoría 4 o 5 en la clasificación de Rutherford, lo que incluye una presión sistólica en el tobillo < 50 mmHg, o una presión sistólica en el dedo del pie < 0 mmHg o TcPO2 < 30 mmHg.
    E.4Principal exclusion criteria
    1. Advanced CLI defined as presence of major tissue loss as significant ulceration/gangrene proximal to the metatarsal heads (CLI Rutherford Category 6). Significant ulceration/gangrene means anyulceration that extends beyond the subcutaneous tissue layer, or any gangrene or tissue necrosis proximal to the metatarsal heads.
    2. Uncontrolled or untreated proliferative retinopathy.
    3. Failed surgical or endovascular revascularization on the index leg within 10 days of the Screening Visit (Visit A).
    4. Subjects in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory or non-atherosclerotic disorder (e.g., thromboangiitis obliterans (Buerger?s Disease), systemic sclerosis (both limited and diffuse forms).
    5. Clinical evidence of invasive infection on index leg (foot sepsis).
    6. At screening, the presence of one or more neuropathic ulcers on the index leg and no ischemic ulcers.
    7. Amputation at or above the talus on the index leg.
    8. Planned major amputation within the first month after randomization.
    9. Subjects who may not be healthy enough to successfully complete all protocol requirements including BM collection, or who are not expected to survive more than 12 months, or in whom results may be particularly difficult to assess, as assessed by the Investigator.
    1.isquemia crítica de extremidades inferiores avanzada definida como una pérdida de tejido importante o ulceración/gangrena importante proximal a la cabeza del metatarso (Isquemia Crítica de MMII de categoría 6 en la clasificación de Rutherford). Por ulceración/gangrena importante se entiende toda ulceración que se extienda más allá de la capa de tejido subcutáneo, o toda gangrena o necrosis tisular proximal a la cabeza del metatarso.
    2.Retinopatía proliferativa no tratada o no controlada.
    3.Revascularización quirúrgica o endovascular fallida en la pierna afectada dentro del plazo de 10 días antes de la visita de selección (Visita A).
    4.Sujetos en los que la insuficiencia arterial en el miembro inferior es consecuencia de una isquemia aguda de extremidades inferiores o de un trastorno inmunológico, inflamatorio o no aterosclerótico (p. ej., tromboangeitis obliterante (enfermedad de Buerger) o esclerosis sistémica [tanto en su forma limitada como difusa]).
    5.Evidencia clínica de infección invasiva en la pierna afectada (sepsis del pie).
    6.En la selección, la presencia de una o más úlceras neuropáticas en la pierna afectada y ninguna úlcera isquémica.
    7.Amputación a la altura del astrágalo de la pierna afectada o por encima.
    8.Amputación mayor planificada para el primer mes después de la randomización.
    9.Retinopatía proliferativa no tratada o no controlada.
    E.5 End points
    E.5.1Primary end point(s)
    Clinically relevant response in the Rutherford Category at 12 months after administration of
    Rexmyelocel-T or placebo. Clinical response is defined as change in Rutherford classification
    from CLI Category 4 or 5 to Category 3 or lower at 12 months after administration.
    Respuesta clínicamente relevante en la categoría Rutherford 12 meses después de la administración. La respuesta clínica se define como un cambio en la clasificación de Rutherford, de una categoría 4 o 5 de la isquemia crítica de extremidades inferiores a una categoría 3 o inferior 12 meses después de la administración de Rexmyelocel-T o placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months post-administration of Rexmyelocel-T or placebo.

    A blinded independent adjudication committee (IAC) will confirm the eligibility of all subjects
    before a subject is randomized, and interpret clinical and hemodynamic data to confirm the
    Rutherford Category of PAD of each subject at the Baseline Visit (Visit 1) and at 3, 6, 12, 18
    and 24 months after administration of Rexmyelocel-T or placebo
    12 meses después de la administración de Rexmyelocel-T o placebo

    Un comité de adjudicación independiente cegado (IAC) confirmará la elegibilidad de todos los sujetos antes de que un sujeto es aleatorizado, e interpretará los datos clínicos y hemodinámicos para confirmar la
    en la puntuación de Rutherford de la EAP de cada sujeto en la visita inicial (visita 1), y en los meses 1, 2, 3, 6, 9, 12, 18 y 24 después de la administración de Rexmyelocel-T o placebo
    E.5.2Secondary end point(s)
    Change in Rutherford score (Categories 0-6).
    ? Presence of ischemic ulcers (yes/no).
    ? Presence of ischemic rest pain (yes/no).
    ? Amputation free survival (AFS).
    Cambio en la puntuación de Rutherford (categorías 0-6)
    Presencia de úlceras isquémicas (sí/no)
    Presencia de dolor isquémico en reposo (sí/no)
    Supervivencia sin amputación (SSA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months post administration of Rexmyelocel-T or placebo
    12 meses después de la administración de Rexmyelocel-T o placebo
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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 Information not present in EudraCT
    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
    All subjects will be followed up until 24 months after the administration of Rexmyelocel-T or placebo.
    Última visita del último paciente
    Se realizará un seguimiento de todos los pacientes durante 24 meses después la administración de Rexmyelocel-T o placebo.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 141
    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)
    All subjects will be followed up until 24 months after the administration of Rexmyelocel-T or placebo. After that patients will be threated per standard clinical practice.
    Se realizará un seguimiento de todos los pacientes durante 24 meses después la administración de Rexmyelocel-T o placebo. Después los pacientes serán tratados de acuerdo con la práctica clínica 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 Decision2016-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-01
    P. End of Trial
    P.End of Trial StatusRestarted
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