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hCT-MSC en niños con trastorno del espectro autista (IMPACT)

28 de mayo de 2026 actualizado por: Joanne Kurtzberg, MD

Un estudio de fase II de hCT-MSC, un producto de células del estroma mesenquimatoso derivado del cordón umbilical, en niños con trastorno del espectro autista

El propósito de este estudio de Fase II es determinar la eficacia de las células del estroma mesenquimatoso derivadas del tejido del cordón umbilical humano (hCT-MSC) para mejorar las habilidades de comunicación social en niños con trastorno del espectro autista (TEA).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

El objetivo de este estudio de fase II doble ciego es determinar la eficacia de las células del estroma mesencial derivadas del tejido del cordón umbilical humano (hCT-MSC), administradas en dos estrategias de dosificación diferentes, en niños con trastorno del espectro autista (TEA).

Este estudio incluirá a niños con ASD, de 4 a 11 años de edad. Los sujetos que califiquen se someterán a una evaluación neuropsicológica, pruebas de EEG, seguimiento ocular, evaluaciones de CVA e infusión del producto del estudio. Los sujetos serán asignados al azar a uno de los dos brazos del estudio; 1) una infusión única de 6,0x106 células/kg al inicio, seguida de una infusión ciega de placebo a los seis meses o, 2) infusión de placebo al inicio, seguida de una dosis intravenosa de 6x106 células/kg a los seis meses.

El criterio principal de valoración de este estudio es el cambio en la habilidad de comunicación social desde el inicio hasta los seis meses. Los riesgos potenciales asociados con la infusión de MSC incluyen una reacción al producto (sarpullido, dificultad para respirar, sibilancias, dificultad para respirar, hipotensión, hinchazón alrededor de la boca, garganta u ojos, taquicardia, diaforesis), transmisión de infecciones y sensibilización HLA.

Tipo de estudio

Intervencionista

Inscripción (Actual)

137

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Duke University Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

4 años a 11 años (Niño)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión

  1. Edad ≥ 4 años a < 12 años (11 años, 364 días) en el momento del consentimiento
  2. Diagnóstico clínico confirmado del DSM-5 de trastorno del espectro autista utilizando la Lista de verificación del DSM-5 según lo informado por la Breve observación de los síntomas del autismo (BOSA) y la Entrevista de diagnóstico del autismo revisada (ADI-R)
  3. Prueba de X frágil realizada y negativa; Se realizó CMA y/o secuenciación del exoma completo y los resultados no se relacionaron con el diagnóstico de autismo
  4. Estable con el régimen de medicación psiquiátrica actual (dosis y programa de dosificación) durante al menos 2 meses antes de la infusión del producto del estudio
  5. Recuento absoluto normal de linfocitos (≥1200/uL para participantes afroamericanos y ≥1500/uL para todos los demás participantes)
  6. GAI ≥ 65 a través de pruebas cognitivas realizadas por el personal del estudio
  7. El participante y el padre/tutor hablan inglés
  8. Capaz de viajar a la Universidad de Duke dos veces (línea de base, seis meses), y el padre/tutor puede participar en encuestas y entrevistas provisionales
  9. Consentimiento del padre/tutor de al menos uno de los padres/tutor

Criterio de exclusión

  1. General:

    1. La revisión de registros médicos y/o evaluaciones de detección indica diagnóstico de TEA y/o GAI > 65 sin confianza
    2. Diagnóstico conocido de cualquiera de las siguientes condiciones psiquiátricas coexistentes: depresión, trastorno bipolar, esquizofrenia, trastorno obsesivo compulsivo asociado con el trastorno bipolar, síndrome de Tourette
    3. Los datos de detección sugieren que el participante no podría cumplir con los requisitos de los procedimientos del estudio según lo evaluado por el equipo del estudio.
    4. La familia no quiere o no puede comprometerse a participar en todas las evaluaciones relacionadas con el estudio, incluido el seguimiento del protocolo
    5. El hermano está inscrito en este estudio (Duke IMPACT)

  2. Genético:

    1. Los registros indican que el niño tiene un síndrome genético conocido como (pero no limitado a) síndrome X frágil, neurofibromatosis, síndrome de Rett, esclerosis tuberosa, mutación PTEN, fibrosis quística, distrofia muscular o un defecto genético definitivamente asociado con ASD
    2. Mutación patógena conocida o variación del número de copias (CNV) asociada con TEA (p. ej., 16p11.2, 15q13.2, 2q13.3)

  3. Infeccioso:

    1. Infección activa conocida del SNC
    2. Evidencia de infección no controlada basada en registros o evaluación clínica
    3. Seropositividad conocida al VIH
    4. Exposición a COVID-19 en los 14 días anteriores o prueba de COVID-19 positiva en los 28 días anteriores. Los sujetos con antecedentes de infección por COVID-19 deben estar libres de síntomas durante 14 días antes de la visita inicial.

  4. Médico:

    1. Trastorno metabólico conocido
    2. Disfunción mitocondrial conocida
    3. Antecedentes de epilepsia inestable o trastorno convulsivo no controlado, espasmos infantiles, síndrome de Lennox Gastaut, síndrome de Dravet u otro trastorno convulsivo crónico similar
    4. Neoplasia maligna activa o neoplasia maligna anterior que se trató con quimioterapia
    5. Antecedentes de un trastorno de inmunodeficiencia primaria
    6. Antecedentes de citopenias autoinmunes (es decir, ITP, AIHA)
    7. Condición médica coexistente que pondría al niño en mayor riesgo de complicaciones de los procedimientos del estudio
    8. Enfermedad genética o adquirida concurrente o comorbilidad(es) que podrían requerir un futuro trasplante de células madre
    9. Deterioro sensorial significativo (p. ej., ceguera, sordera, deficiencia auditiva no corregida) o motor (p. ej., parálisis cerebral)
    10. Deterioro de la función renal o hepática determinada por creatinina sérica > 1,5 mg/dl o bilirrubina total > 1,3 mg/dl, excepto en pacientes con enfermedad de Gilbert conocida
    11. Anomalías hematológicas significativas definidas como: hemoglobina <10,0 g/dL, plaquetas <150 x 10e9/uL, WBC <3000 células/mL, ALC <1200/uL para afroamericanos o <1500/uL para todos los demás participantes.
    12. Evidencia de dismorfología física clínicamente relevante indicativa de un síndrome genético según la evaluación de los PI u otros investigadores, incluidos un médico genetista y psiquiatras capacitados para identificar características dismórficas asociadas con afecciones del desarrollo neurológico.

  5. Terapia actual/anterior:

    a. Disponibilidad de una unidad de sangre de cordón autóloga calificada almacenada en un banco o uso diferido de los padres de una unidad de sangre de cordón autóloga calificada b. Antecedentes de terapia celular previa c. Uso actual o anterior de IVIG u otros medicamentos antiinflamatorios con la excepción de los AINE d. Terapia inmunosupresora actual o previa i. Sin terapia con esteroides sistémicos que haya durado más de 2 semanas y sin esteroides sistémicos en los 3 meses anteriores a la inscripción. Se permiten esteroides tópicos e inhalados.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: MSC
Una dosis de 6x10e6 células/kg administrada por vía intravenosa.
Biológico: Células del estroma mesenquimatoso del tejido del cordón
Células estromales mesenquimales derivadas de tejido de cordón umbilical humano (hCT-MSC), aisladas y expandidas a partir de tejido de cordón umbilical de donantes alogénicos no emparentados. Una dosis de 6x10e6 células/kg administrada por vía intravenosa.
Comparador de placebos: Infusión de placebo
Otro: Infusión de placebo
Infusión comparativa de placebo

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change on the Average Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales (VABS-3)
Periodo de tiempo: Baseline, 6 months
The primary outcome measure is the mean of the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form. The primary endpoint is the change in this outcome measure from baseline to six months before the second infusion. A positive change in the scores indicates an improvement in socialization and communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score
Periodo de tiempo: Baseline, 6 months
The change in the Socialization Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from baseline to six months. Higher Socialization Standard scores indicate greater socialization. A positive change in the scores indicates an improvement in socialization. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 Communication Standard Score
Periodo de tiempo: Baseline, 6 months
The change in the Communication Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form from baseline to six months before the second infusion. Higher scores indicate greater communication. A positive change in the scores indicates an improvement in communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
CGI-S (Clinical Global Impression - Severity of Illness) Overall Score
Periodo de tiempo: 6 months
The CGI-S Overall Score is a 7-point scale that requires the clinician to rate the severity of the participant's overall functioning and symptoms of autism at the time of assessment, relative to the clinician's experience with participants who have the same diagnosis. The clinician rates the severity of autism symptoms - 1, normal, no symptoms; 2, borderline level of symptoms; 3, mild symptoms; 4, moderate symptoms; 5, marked symptoms; 6, severe symptoms; or 7, extremely severe symptoms. The higher ratings indicate greater severity of overall functioning impairment.
6 months
CGI-I (Clinical Global Impression - Improvement) Overall Score
Periodo de tiempo: 6 months
The CGI-I Overall Score is a 7-point scale that requires the clinician to assess how much the participant's autism overall functioning and symptoms have improved or worsened relative to a baseline assessment. The symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The lower scores indicate greater improvement.
6 months
Change in the Pediatric Quality of Life (PedsQL) Total Scale Score
Periodo de tiempo: Baseline, 6 months
The PedsQL 4.0 Generic Core Scales is a 5-minute parent questionnaire that measures the child's functioning in the dimensions of physical, emotional, social, and school. The items use a Likert rating scale from 0 (Never) to 4 (Almost Always). This 0-4 scale is then transformed to 0=100, 1=75, 2=50, 3=25, and 4=0 for a reverse score. The Total Scale Score is then computed as the sum of all the items over the number of items answered on all the Scales for a total score range of 0 to 100. Higher scores indicate a better quality of life.
Baseline, 6 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Experiencing an Infusion Reaction
Periodo de tiempo: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not what they were randomized. Patients received the infusion to which they were randomized at baseline and the alternate treatment at 6 months. Therefore, adverse events are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion).
up to 12 months
Number of Participants Experiencing Product-related Infections
Periodo de tiempo: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Evidence of Formation of Anti-HLA Antibodies
Periodo de tiempo: Baseline, 6 months, 12 months
Assess for anti-HLA antibodies
Baseline, 6 months, 12 months
Number of Participants Experiencing Graft Versus Host Disease (GVHD)
Periodo de tiempo: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Number of Participants Experiencing Unexpected Adverse Events Related to the Study Product
Periodo de tiempo: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Change on the Adaptive Behavior Composite Subscale Standard Score on the Vineland Behavior Scales (VABS-3)
Periodo de tiempo: Baseline, 6 months
The change in the Vineland Adaptive Behavior Scales (VABS-3) Adaptive Behavior Composite Subscale from baseline to 6 months before the second infusion. Higher Adaptive Behavior Composite Standard scores indicate greater adaptive behavior. A positive change in the scores indicates an improvement in adaptive behavior. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 (Vineland Adaptive Behavior Scales) Daily Living Skills Standard Score
Periodo de tiempo: Baseline, 6 months
The change in the Daily Living Skills Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from baseline to six months before the second infusion. Higher Daily Living Skills Standard scores indicate greater daily living skills. A positive change in the scores indicates an improvement in daily living skills. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 Motor Skills Standard Score
Periodo de tiempo: Baseline, 6 months
The change in the Motor Skills Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form from baseline to six months before the second infusion. Higher scores indicate greater motor skills. A positive change in the scores indicates an improvement in motor skills. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in Aberrant Behavior Checklist-Community (ABC-C) Social Withdrawal
Periodo de tiempo: Baseline, 6 months
The change in the Aberrant Behavior Checklist-Community (ABC-C) Social Withdrawal scale from baseline to six months before the second infusion. Higher scores indicate greater problems with social withdrawal. A positive change in the scores indicates a worsening in social withdrawal. This scale has 16 items that are scored on a 4-point Likert scale: 0 = not a problem, 1 = slight problem, 2 = moderately serious problem, 3 = severe problem. The individual items are added together to calculate the Social Withdrawal scale score.
Baseline, 6 months
Change in Pervasive Developmental Disorder Behavior Inventory (PDDBI) Total Score
Periodo de tiempo: Baseline, 6 months
The change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI) from baseline to 6 months before the second infusion. The PDDBI is a measure of problem behaviors and social, language, and learning or memory skills of children who have been diagnosed with autism spectrum disorder. Raw scores are converted to T-scores. The T-score has a mean of 50 with a standard deviation of 10 points with a range of 10-100. Higher scores indicate greater behavioral issues and a positive change in score indicates worsening.
Baseline, 6 months
Change in the Autism Impact Measure (AIM)
Periodo de tiempo: Baseline, 6 months
The change in the Autism Impact Measure (AIM) from baseline to 6 months before second infusion. AIM is a measure of core Autism Spectrum Disorder Symptoms. It is a parent-report questionnaire that includes 41 core-symptom items rated on two corresponding 5-point scales: frequency (ranging from "never" to "always") and impact (ranging from "not at all" to "severely") over the previous two weeks. Frequency and impact ratings are combined, yielding a total score range of 82 to 410. Higher scores indicate greater symptom severity; a positive change in score indicates worsening of symptoms.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Emotional Control Subscale
Periodo de tiempo: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Emotional Control subscale from baseline to month 6 before the second infusion. BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Working Memory Subscale
Periodo de tiempo: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Working Memory subscale from baseline to month 6 before the second infusion. The BREIF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Inhibit Subscale
Periodo de tiempo: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Plan/Organization Subscale
Periodo de tiempo: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Plan/Organization subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Shift Subscale
Periodo de tiempo: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Shift subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Expressive Vocabulary Test (Third Edition, EVT-3)
Periodo de tiempo: Baseline, 6 months
The change in the Expressive Vocabulary Test (Third Edition, EVT-3) from baseline to 6 months before the second infusion. The EVT-3 is a measure of a participant's ability to match a spoken word with an image of an object, action, or concept. The number of words that are retrieved is converted to a Standard Score, where 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers. A positive change in EVT-3 score indicates improvement.
Baseline, 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Joanne Kurtzberg, MD

Colaboradores

The Marcus Foundation
Cryo-Cell International

Investigadores

  • Investigador principal: Lauren Franz, MBChB, Duke University
  • Investigador principal: Beth Shaz, MD, Duke University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de octubre de 2020

Finalización primaria (Actual)

2 de mayo de 2023

Finalización del estudio (Actual)

1 de febrero de 2024

Fechas de registro del estudio

Enviado por primera vez

12 de septiembre de 2019

Primero enviado que cumplió con los criterios de control de calidad

12 de septiembre de 2019

Publicado por primera vez (Actual)

13 de septiembre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Pro00113011
  • Pro00102894 (Otro identificador: Duke IRB)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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