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    Summary
    EudraCT Number:2018-000886-35
    Sponsor's Protocol Code Number:AloFem
    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:2018-04-09
    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 number2018-000886-35
    A.3Full title of the trial
    Evaluation of safety, feasibility and preliminary efficacy of MSCs from third party donors in the treatment of patients with osteonecrosis of the femoral head after allogeneic Stem Cell Transplantation (AloFem)
    Evaluación de la seguridad, viabilidad y eficacia preliminar de CMMs de donantes, en el tratamiento de pacientes con osteonecrosis de la cabeza femoral tras un trasplante alogénico de Células Madre (AloFem)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of safety, feasibility and preliminary efficacy of MSCs from third party donors in the treatment of patients with osteonecrosis of the femoral head after allogeneic Stem Cell Transplantation
    Evaluación de la seguridad, viabilidad y eficacia preliminar de CMMs de donantes, en el tratamiento de pacientes con osteonecrosis de la cabeza femoral tras un trasplante alogénico de Células Madre
    A.3.2Name or abbreviated title of the trial where available
    AloFem
    A.4.1Sponsor's protocol code numberAloFem
    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 SponsorEnrique Gomez-Barrena
    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 supportInstituto Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH.U. Puerta de Hierro
    B.5.2Functional name of contact pointConcepcion Payares-Herrera
    B.5.3 Address:
    B.5.3.1Street AddressManuel de Falla 1
    B.5.3.2Town/ cityMajadahonda (Madrid)
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number34911916481
    B.5.5Fax number34911917650
    B.5.6E-mailcpayares@idiphim.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 nameCultured mesenchymal stem cells from bone marrow isolation
    D.3.2Product code BM-MSCs
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllogenic MESENCHYMAL STEM CELLS
    D.3.9.2Current sponsor codeBM-MSCs
    D.3.9.3Other descriptive nameHUMAN MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB191337
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/ml colony forming unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000000
    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
    Osteonecrosis of the Femoral Head
    Osteonecrosis de la cabeza femoral
    E.1.1.1Medical condition in easily understood language
    Osteonecrosis of the Femoral Head
    Osteonecrosis de la cabeza femoral
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031264
    E.1.2Term Osteonecrosis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10003860
    E.1.2Term Avascular necrosis femoral head
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 assess the safety, feasibility and preliminary efficacy of bone marrow-derived allogenic MSCs use in the treatment of osteonecrosis of femoral head (ONFH), with placement at necrosis site
    Evaluar la seguridad, viabilidad y eficacia preliminar del uso de células madre mesenquimales de médula ósea (CMM) alogénica en el tratamiento de osteonecrosis de la cabeza femoral (ONCF), con administración en el lugar de la necrosis.
    E.2.2Secondary objectives of the trial
    To obtain bone regeneration maintaining head sphericity and/or avoiding progression of femoral head collapse, without increasing the complication rate, in femoral heads with symptomatic osteonecrosis of femoral head (ONFH)
    Obtener regeneración ósea, manteniendo la esfericidad y/o evitando la progresión del colapso de la cabeza femoral, sin aumentar la tasa de complicaciones, en osteonecrosis de la cabeza femoral sintomáticas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age: 8 to 55, both sexes
    - Patients having received allogeneic haematological stem cell transplant (HSCT), due to hematologic diseases, in remission. The patient may be or have been under immunosupression.
    - Osteonecrosis of the femoral head (MRI diagnosis): Ficat and Arlet 0, 1, 2 or 3 or ARCO stages 0, I, IIA, IIB, IIC, IIIA, IIIB, IIIC or Steinberg stages 0, I, II, III.
    - Able to provide informed consent, and signed informed consent (by themselves or legal representative)
    - Medical health care coverage
    - Able to understand and accept the study constraints (by themselves or legal representative)
    - Edad: 8 a 55 años, ambos sexos
    - Pacientes receptores de un trasplante alogénico de células madre hematopoyéticas, en remisión. El pacientes pueda estar con/sin tratamiento inmunosupresor
    - Osteonecrosis de la cabeza femoral (diagnostico por RMN): Ficat y Arlet 0, 1, 2 o 3; o estadios ARCO 0, I, IIA, IIB, IIC, IIIA, IIB, IIIC; o estadios Steinberg 0, I, II, III.
    - Capacidad de proporcionar consentimiento informado y firmarlo (por el paciente o su representante legal)
    - Disponer de cobertura sanitaria
    - Entender y aceptar los requisitos del estudio (el paciente o su representante legal)
    E.4Principal exclusion criteria
    - Disease in relapse
    - Active infection of any location and aetiology
    - Surgical contraindication of any cause
    - Pregnancy, breastfeeding women and women who are of childbearing age and not practicing adequate birth control.
    - Stage 4 (Ficat and Arlet) or IV and above (Steinberg) or ARCO IV, with severe femoral head osteonecrosis associated to acetabular changes, primarily based on diagnosis by imaging (X-Rays, MRI)
    - Flattening or collapse of the femoral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery
    - Any tumour infiltration of the femoral head and/or neck
    - Other tumour infiltration with short-term life risk
    - Stress or pathological fracture of the femoral neck
    - Traumatic osteonecrosis
    - Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, monostotic or polyostotic fibrous dysplasia, McCune-Albright syndrome and osteopetrosis)
    - Any active bisphosphonate treatment (or 3 months before the trial, except in case they are used in the treatment of an acute disorder that requires prompt management, e.g., severe hypercalcemia, severe bone pain).
    - Any evidence of HIV, Hepatitis B or Hepatitis C infection (confirmed by serology or PCR)
    - Known allergies to products involved in the production process of MSC
    - History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of screening and/or history of illicit drug use
    - MRI incompatible internal devices (pacemakers, aneurysm clips, etc.)
    - Impossibility to meet at the appointments for the clinical follow up
    - Recaída de la enfermedad hematológica.
    - Infección activa, en cualquier localización y de cualquier etiología.
    - Contraindicación quirúrgica de cualquier tipo.
    - Embarazo, lactancia o mujeres en edad fértil que no practiquen un método anticonceptivo adecuado.
    - Estadio 4 (Ficat and Arlet) o IV y superior (Steinberg) o ARCO IV, con osteonecrosis femoral grave asociada a cambios acetabulares, basado principalmente en diagnóstico radiológico (radiografía, RMN).
    - Aplanamiento o colapso de la cabeza femoral (estadio Steinberg IV) o colapso del cartílago articular en el momento de la cirugía de descompresión.
    - Infiltración tumoral del cuello o la cabeza femorales.
    - Otras infiltraciones tumorales con riesgo vital a corto plazo.
    - Fractura patológica o por estrés del cuello femoral.
    - Osteonecrosis traumática.
    - Enfermedades metabólicas óseas distintas a la osteonecrosis (en especial enfermedad de Paget ósea, osteogénesis imperfecta, hiperparatiroidismo primario, displasia fibrosa (afectación mono- o poliósea), síndrome de McCune-Albright y osteopetrosis).
    - Tratamiento con bifosfonatos actual o en los 3 meses previos a la inclusión en el ensayo (excepto si se han usado para el tratamiento de alteraciones agudas que requieren un manejo clínico inmediato, por ejemplo hipercalcemia grave o dolor óseo grave).
    - Infección por VIH, hepatitis B o C, confirmadas por serología o PCR.
    - Antecedentes de alergias a productos involucrados en el proceso de produccion de CMMs.
    - Antecedentes de consumo habitual de alcohool excediendo 2 bebidas/día (1 bebida= 150mL de vino o 360mL de cerveza o 45mL de licor destilado) en los 6 meses previos al screening y/o antecedente de uso de drogas de abuso.
    - Ser portador de un dispositivo interno no compatible con RMN (marcapasos, clips para aneurismas, etc.).
    - Imposibilidad de acudir a las citas médicas para el seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    - Early local complication rate, as the percentage of patients with local complications within 12 weeks after surgery
    - Global complication rate, as the percentage of patients with local or general complications at 52 weeks.
    - Tasa de complicaciones locales tempranas, definidas como el porcentaje de pacientes con complicaciones locales en las 12 semanas después de la cirugía.
    - Tasa de complicaciones globales, como el porcentaje de pacientes con complicaciones locales o generales a las 52 semanas después de la cirugía
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 and 52 weeks
    12 y 52 semanas
    E.5.2Secondary end point(s)
    - Local and general complication rate at 12, 24 and 104 weeks
    - Rate of bone healing, as the percentage of patients without clinical and radiological progression at 52 weeks.
    - Rate of patients with no clinical progression to the next stage (defined as 0 to 1, 1 to 2, 2 to 3 and 3 to 4) at 52 weeks, particularly assessing the progression to femoral head flattening (Steinberg IV and over)..
    - Rate of patients with no radiological or MRI progression at 6 weeks (X-ray), 12 weeks (X-ray, MRI), 24 weeks X-ray), and 52 weeks (X-ray, MRI).
    - Amount of necrotic bone in the femoral head at 12 weeks and 52 weeks in MRI, compared with preoperative status.
    - Changes in serum levels of bone turnover markers (in a centralized laboratory) at 12, 24 and 52 weeks after treatment, compared with preoperative levels.
    - Pain assessed by Likert Scale (1 to 10) at 12, 24 and 52 weeks
    - Tasa de complicaciones locales y generales a las semanas 12, 24 y 104.
    - Tasa de regeneración ósea, definida como el porcentaje de pacientes sin progresión clínica ni radiológica a las 52 semanas.
    - Tasa de pacientes sin progresión clínica al siguiente estadio (definida como progresión de 0 a 1, 1 a 2, 2 a 3, 3 a 4) a las 52 semanas, en especial valorando la progresión a aplanamiento de la cabeza femoral (Steinberg IV o superior).
    - Tasa de pacientes sin progresión radiológica o en RMN a las 6 semanas (radiografía), 12 semanas (radiografía, RMN), 24 semanas (radiografía) y 52 semanas (radiografía, RMN).
    - Cantidad de hueso necrótico en la cabeza femoral a las 12 y 52 semanas mediante RMN, en comparación con el estado pre-operatorio.
    - Cambios en los niveles séricos de marcadores óseos a las 12, 24 y 52 semanas post-tratamiento, con respecto a los niveles pre-cirugía.
    - Evaluación del dolor, mediante la escala de Likert (de 1 a 10), a las 12 y 52 semanas, en comparación con la situación pre-cirugía (visita 2, día anterior a la cirugía).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 24, 52 or 104 weeks
    12, 24, 52 o 104 semanas
    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 No
    E.8.1.1Randomised No
    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 No
    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
    LVLS
    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 months0
    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 Yes
    F.1.1Number of subjects for this age range: 4
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 3
    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 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 state7
    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)
    If bone healing has not occurred or there is progression of ONFH, the patient may require additional treatment and additional follow up, under the care of the Hospital, the treating physician or service, or the provider in charge of his process, even if unrelated to the study.
    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 Decision2018-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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