- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01456819
Intramuscular Mononuclear Cells and Mesenchymal Stem Cells Transplantation to Treat Chronic Critical Limb Ischemia
Phase II Efficacy Study of Intramuscular Autologous Bone Marrow Mononuclear Cells Plus Mesenchymal Stem Cell Implantation Versus Autologous Bone Marrow Mononuclear Cells Implantation Only in Patients With Chronic Critical Limb Ischemia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
When the long blood vessels supplying blood to the arms and legs become blocked (ischemic), patient will experience painful sensations in their calves when they walked which slowly become excruciating painful at rest. When the condition worsens, the patients will not be able to feel any pain from their legs and they will not know if there are any small ulcers or cuts on their legs. As a result, a small ulcer which goes unnoticed becomes bigger and can sometimes become infected. In the worst situations, infection might lead towards gangrene and septicaemia. Severe rest pain and/or ulcerations of ischemic limbs are defined as the state of chronic critical limb ischemia and at this point, amputation of the affected limb is suggested.
Conventional treatments include angioplasty/bypass operation to remove blood vessel blockage to restore blood supply, the use of prescribed medicines to aid in ulcer recovery and clear infection and debridement of damaged/infected tissue. Some procedures have to be performed multiple times. Amputation is inevitable in many cases because some blood capillaries cannot be corrected and restenosis of vessels is very common. Cell therapy with mononuclear cells and mesenchymal stem cells from bone marrow is promising because these stem cells are capable of stimulating and regenerating capillaries and blood vessels.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hanafiah Harunarashid, MD
- Número de teléfono: +60391456208
- Correo electrónico: hanafiah@ppukm.ukm.my
Ubicaciones de estudio
-
-
-
Kuala Lumpur, Malasia, 56000
- Reclutamiento
- UKM Medical Centre
-
Contacto:
- Hanafiah Harunarashid, MD
-
Investigador principal:
- Hanafiah Harunarashid, MD
-
Sub-Investigador:
- Mohammad Azim Mohammad Idris, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of critical limb ischemia leading to ischemic ulcers in which amputation is indicated
- Not suitable for, or remain symptomatic despite angioplasty, bypass operation or collateralization
Exclusion Criteria:
- Contraindication to epidural anesthesia and bone marrow aspiration
- Contraindication to contrast angiography
- Evidence of neoplasia and bone marrow diseases
- Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV
- Patients with a limited life expectancy (< 1 year)
- Patients with myocardial infarction or stroke within 6 months
- Patients with coronary intervention within 6 months
- Renal impairment indicated by serum creatinine greater than two times upper limit of the normal range
- Liver impairment indicated by serum aspartate transaminase and alanine transaminase greater than two times upper limit of normal
- Any other co-morbidity which the physician deems as a contraindication to stem cell transplantation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Mononuclear and mesenchymal stem cells
Autologous bone marrow-derived mononuclear cells and mesenchymal stem cells
|
Intramuscular administration into the ischemic limb
Otros nombres:
|
Comparador activo: Mononuclear cells only
Autologous bone marrow-derived mononuclear cells
|
Intramuscular administration into the ischemic limb
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in angiogenesis
Periodo de tiempo: 1 month, 3 months, 6 months, 9 months, 12 months
|
Measurement of angiogenesis by presence of peripheral pulses, capillary refill and transcutaneous oxygen saturation (TCOS).
|
1 month, 3 months, 6 months, 9 months, 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Puntuación analógica visual
Periodo de tiempo: 1 mes, 3 meses, 6 meses, 9 meses, 12 meses
|
1 mes, 3 meses, 6 meses, 9 meses, 12 meses
|
|
Change in ulcer size
Periodo de tiempo: 1 month, 3 months, 6 months, 9 months, 12 months
|
Measurement of ulcer size by clinical assessment and grid maps.
|
1 month, 3 months, 6 months, 9 months, 12 months
|
Exercise Treadmill Test
Periodo de tiempo: 1 month, 3 months, 6 months, 9 months, 12 months
|
1 month, 3 months, 6 months, 9 months, 12 months
|
|
Improvement in vascularity and blood supply
Periodo de tiempo: 1 month, 3 months, 6 months, 9 months and 12 months
|
Measured by digital subtraction angiography (DSA) and ankle brachial systemic pressure index (ABI).
|
1 month, 3 months, 6 months, 9 months and 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hanafiah Harunarashid, MD, UKM Medical Centre
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- FF-113-2011
- NMRR-11-904-9763 (Identificador de registro: National Medical Research Register)
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. .