- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03106662
Mesenchymal Stem Cell Infusion in Haploidentical Hematopoietic Stem Cell Transplantation in Patients With Hematological Malignancies
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Mesenchymal stem cells (MSCs) have been utilized in the treatment and prevention of graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation (alloSCT). However, studies on MSC use in alloSCT from haploidentical donors (haploSCT) have been limited.
In this study, the investigators aim 1) to evaluate MSCs' efficacy in GVHD prophylaxis and effect on engraftment of the haploidentical graft, 2) to improve the success rate of haploSCT by further decreasing GVHD incidence and graft failure rate. With higher haploSCT success rates, haploidentical donors would be important alternative graft sources in patients without HLA-matched donors.
Forty patients who present to Ankara University, School of Medicine, Division of Hematology with hematological malignancies and have indications for haploSCT will be included in the study after informed consent is obtained. MSCs will be procured and isolated from donor bone marrows. MSCs will be isolated, cultured, and stored in the good manufacturing practice (GMP) laboratory in Ankara University Stem Cell Institute. Donor bone marrow will be harvested, four to six weeks prior to transplantation, for MSC isolation and culture. Patients will receive either an ablative or non-ablative induction regimen based on their age, diagnosis, and the disease status at the time of transplantation. Donor bone marrow will be harvested a second time on the day of transplantation and the procured bone marrow graft will be infused to the patient the same day. GVHD prophylaxis will include post-transplantation cyclophosphamide (Cy) on days +3 and +4 (50 mg/kg/day), tacrolimus, and mycophenolate mofetil. Stored MSCs will be infused to the patient on day +6. The endpoints include graft failure rate, GVHD incidence, transplant-related mortality, disease-free survival, and overall survival.
The investigators aim to evaluate the utility of MSCs in improving haploSCT results and to enhance the reliability and success of haploSCT. Successful transplants from haploidentical donors would ameliorate the problem of matched donor paucity in countries with a limited number of hematopoietic stem cell donors, such as Turkey, and would establish haploidentical donors an alternative donor source for patients without matched donors in Turkey. As haploidentical donors may be parents or children, rapid and easy access to donors would decrease wait times for alloSCT. Moreover, national current account deficit may be reduced through using grafts obtained from haploidentical donors residing in Turkey instead of grafts from foreign stem cell/umbilical cord banks.
In this project, the investigators seek to develop clinical therapy applications in concordant with the ambition of "renewal and repair of human cells, tissues, and organs through cellular therapy and cellular products" that is included in the The Scientific and Technological Research Council of Turkey 1003 Call for Projects.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Ankara, Pavo
- Ankara University School of Medicine Department of Hematology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosed with haematological malignancy
- Indication of haploidentical hematopoietic stem cell transplantation
- No restrictions for transplantation
Exclusion Criteria:
- Any restriction for transplantation
- No indication of haploidentical hematopoietic stem cell transplantation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Mesenchymal Stem Cell in Haplo-SCT
After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day.
At +6 post transplant day, 2-8x10^8 cell/kg mesenchymal stem cells will be infused.
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After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day.
At +6 post transplant day, 2-8x10^8 cell/kg mesenchymal stem cells will be infused.
After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Effect of mesenchymal stem cells on overall survival in haploidentical stem cell transplantation
Periodo de tiempo: 36 months
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36 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Effect of mesenchymal stem cells on graft versus host disease incidence in haploidentical stem cell transplantation
Periodo de tiempo: 36 months
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36 months
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Effect of mesenchymal stem cells on graft failure incidence in haploidentical stem cell transplantation
Periodo de tiempo: 36 months
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36 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias por sitio
- Enfermedades hematológicas
- Neoplasias Hematológicas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Ciclofosfamida
Otros números de identificación del estudio
- 213S196
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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