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    Summary
    EudraCT Number:2021-005124-38
    Sponsor's Protocol Code Number:RADISAC
    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:2021-11-16
    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 number2021-005124-38
    A.3Full title of the trial
    Conditioned Autologous Serum Therapy (Orthokine) on the dorsal root ganglion in patients with chronic radiculalgia (RADISAC)
    Terapia con Suero Autólogo Condicionado (Orthokine) sobre el ganglio de la raíz dorsal en pacientes con radiculalgia crónica (RADISAC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Conditioned Autologous Serum Therapy (Orthokine) administered at the dorsal root ganglion in patients with chronic radiculalgia, to value pain improvement.
    Terapia con Suero Autólogo Condicionado (Orthokine) aplicada sobre el ganglio de la raíz dorsal en pacientes con radiculalgia crónica, para evaluar mejoría del dolor radicular.
    A.3.2Name or abbreviated title of the trial where available
    RADISAC
    RADISAC
    A.4.1Sponsor's protocol code numberRADISAC
    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 SponsorDARYD
    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 supportZaraclinics España
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDARYD
    B.5.2Functional name of contact pointDARYD
    B.5.3 Address:
    B.5.3.1Street AddressSabino Arana
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.6E-mailmartahoms7@gmail.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 Yes
    D.2.1.1.1Trade name Orthokine
    D.2.1.1.2Name of the Marketing Authorisation holderOrthogen AG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameOrthokine
    D.3.2Product code PS-8229-2010
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    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 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 Yes
    D.3.11.9Recombinant medicinal product Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeAutologus condicioned Serum
    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 injection
    D.8.4Route of administration of the placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    lower extremity radicular pain
    Dolor radicular extremidad inferior
    E.1.1.1Medical condition in easily understood language
    lower extremity radicular pain
    Dolor por ciatalgia en pierna
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    To assess whether therapy with conditioned autologous serum on the dorsal root ganglion reduces neuropathic pain in patients with persistent lower limb radiculalgia
    Evaluar si la terapia con Suero autólogo condicionado sobre el ganglio de la raiz dorsal reduce el dolor neuropático de los pacientes con radiculalgia persistente de miembro inferior
    E.2.2Secondary objectives of the trial
    Assess the degree of improvement of neuropathic pain and its symptoms
    Evaluate the functionality of these patients at 30 days, at 3 months and at 6 months, at 12 months.
    To assess the quality of life of these patients at 30 days, 3 months, 6 months and 12 months.
    Assess the mood of these patients at 30 days, 3 months, 6 months and 12 months.
    Evaluar el grado de mejoría de dolor neuropático y sus síntomas
    Evaluar la funcionalidad de estos pacientes a los 30 días, a los 3 meses y a los 6 meses, a los 12 meses.
    Evaluar la calidad de vida de estos pacientes a los 30 días, a los 3 meses, a los 6 meses y a los 12 meses.
    Evaluar el estado anímico de estos pacientes a los 30 días, a los 3 meses, a los 6 meses y a los 12 meses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years, not illiterate, with lower limb radicular pain of more than 6 months.
    Inclusion criteria:
    Unilateral, mono and / or bisegmental radicular pain of a lower limb lasting at least more than 6 months.
    In case of having received treatment previously, at least 3 months must have passed since the last therapy received (infiltration, radiofrequency or surgery) and the pain persist in the same territory.
    Present lumbar Nuclear Magnetic Resonance (NMR), Electromyography (EMG) done concomitantly to the pain that the patient presents at the time of inclusion in the study.

    Present a score greater than 5 in the DN4 questionnaire at the time of inclusion in the study.
    Pacientes mayores de 18 años, no analfabetos, con dolor radicular de miembro inferior de más de 6 meses.
    Criterios de inclusión:
    Dolor radicular unilateral, mono y/o bisegmentario de una extremidad inferior de al menos más de 6 meses de duración.
    En caso de haber recibido tratamiento con anterioridad, debe haber pasado al menos 3 meses desde la última terapia recibida (infiltración, radiofrecuencia o cirugía) y persistir el dolor en el mismo territorio.
    Presentar Resonancia Magnética Nuclear (RMN) lumbar, Electromiografia (EMG) hechas concomitantemente al dolor que presenta el paciente en el momento de inclusión en el estudio.

    Presentar una puntuación mayor de 5 en el cuestionario de DN4 en el momento de inclusión en el estudio.
    E.4Principal exclusion criteria
    exclusion criteria:
    Refusal of the patient to participate in the study or not to sign the informed consent
    Allergy to intravenous iodinated contrast and / or local anesthetics.
    Impossibility of the patient to maintain the prone position.
    Systemic or local infection at the puncture site.
    Present any of the following symptoms: atypical radiation pattern, bilateral involvement, involvement of more than two segments or roots.
    Concomitant pathological history during study / therapy: oncological disease, vertebral fractures, myelopathy, systemic disease, connective tissue disease, coagulation disorder, multiple sclerosis, osteomyelitis, or bone edema.
    Pregnancy or breastfeeding
    Previous treatment with spinal neurostimulator placement
    Previous treatment with brain stimulator for treatment of epilepsy or Parkinson's disease.
    Cardiac pacemaker carrier.
    Patient who does not attend any of the treatment sessions for unjustified reasons.
    Criterios de exclusión:
    Negativa del paciente a participar en el estudio o no firmar el consentimiento informado
    Alergia al contraste iodado endovenoso y/o a los anestésicos locales.
    Imposibilidad del paciente de mantener la posición de decúbito prono.
    Infección sistémica o local en el punto de punción.
    Presentar alguno de los siguientes síntomas: patrón de radiación atípico, afectación bilateral, afectación de más de dos segmentos o raíces.
    Historia clínica patológica concomitante durante el estudio/terapia: enfermedad oncológica, fracturas vertebrales, mielopatia, enfermedad sistémica, conectivopatía, alteración de la coagulación, esclerosis múltiple, osteomielitis, o edema óseo.
    Embarazo o lactancia
    Tratamiento previo con colocación de Neuroestimulador medular
    Tratamiento previo con estimulador cerebral para tratamiento de epilepsia o enfermedad de parkinson.
    Portador de marcapasos cardíaco.
    Paciente que no acuda a alguna de las sesiones de tratamiento por motivo no justificado.
    E.5 End points
    E.5.1Primary end point(s)
    Pain improvement of at least 20%
    Mejoría del Dolor de almenos un 20%
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after therapy
    At 3 months after therapy
    At 6 months after therapy
    At 12 months after therapy
    A los 30 días después de la terapia
    A los 3 meses después de la terapia
    A los 6 meses después de la terapia
    A los 12 meses después de la terapia
    E.5.2Secondary end point(s)
    20% improvement in evaluative tests:

    Oswestry test
    Quality of life test SF 12
    Mood Assessment Test
    Mejoría del 20% de los tests evaluativos :

    Test de Oswestry
    Test de calidad de vida SF 12
    Test de Evaluación estado de ánimo
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after therapy
    At 3 months after therapy
    At 6 months after therapy
    At 12 months after therapy
    A los 30 días después de la terapia
    A los 3 meses después de la terapia
    A los 6 meses después de la terapia
    A los 12 meses después de la terapia
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    The end of the study would be 12 months after the last therapy of the last recruited patient.

    After this moment, the data analysis would be carried out and the final results are expected to be obtained 6 months after the end of the study.
    El Final del estudio seria a los 12meses de la última terapia del último pacinete reclutado.

    Pasado este momento se procedería al análisis de datos y se preve obtener los resultados finales a los 6 meses desde la finalización del estudio.
    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 months6
    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: 50
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    No changes
    Sin cambios
    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 Decision2021-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-16
    P. End of Trial
    P.End of Trial StatusOngoing
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