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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02315235
The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diabetic painful neuropathy a prevalent, disabling disorder. Currently, the only effective treatments are glucose control and pain management. Diabetic neuropathy is characterized by reduction of vascularity in peripheral nerves and deficiency in neurotrophic and angiogenic factors. Recent studies have shown that bone marrow (BM)-derived stem or progenitor cells have favorable effects on the repair of cardiovascular diseases. Since these BM-derived stem or progenitor cells contain various angiogenic and neurotrophic factors, these cells have been attempted for treating experimental diabetic neuropathy, and turned out to be effective for reversing various manifestations of experimental diabetic neuropathy.
However, stem-cell therapy was not proven in human study. Therefore, we will investigate the efficacy and safety of autologous peripheral blood stem cell injection in diabetic neuropathy.
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de
- SeoulNUH
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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:
- symptomatic diabetic neuropathy moderate pain more than 3 months Michigan Neuropathy Screening Instrument (MNSI) >3 3/day mean pain scale > NRS 4 Body weight >50 kg systolic blood pressure: 90-150 mmHg, Diastolic blood pressure <100 mmHg, Body temperature <37.5℃, Pulse rate: 50-100/min
Exclusion Criteria:
- other cause of neuropathy symptomatic peripheral vessel disease skin lesion or arthritis central neuronal disease drug addiction or abuse Aspartate aminotransferase or Alanine aminotransferase >1.5 times than upper normal limit range Creatinine clearance rate <60ml/min or dialysis Myocardial infarction, unstable angina or heart failure diagnosed in 3 months psychologic disorder pregnancy or lactation
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 |
---|---|
Comparador activo: control
The operator inject normal saline(control) to thirty site of the other side leg of active comparator.
The volume of one site injection is 0.5 ml.
The depth of needle injection would be 1.5cm.
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Normal saline is injected in one leg of patient.
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Comparador activo: stem cell (mononuclear cell)
The stem cell (mononuclear cell) is injected to thirty site of one side leg in operating room after general anesthesia.
The volume of one site injection is 0.5 to 1.0 ml.
The depth of needle injection would be 1.5cm.
|
Granulocyte colony-stimulating factor (G-CSF) is injected into subcutaneous for three days prior to the blood collection (D-3 to D-1). Peripheral mononuclear stem-cell is collected by Cobe spectra apheresis system in D-day. The stem-cell (mononuclear cell) is injected into the muscle in the other side leg of patient. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in pain for a week after the procedure
Periodo de tiempo: baseline, 4 week, 12 week
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The pain scale was calculate by Numeric rating scale (NRS).
We observe a change in NRS pain scores during the follow-up period.
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baseline, 4 week, 12 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The evaluation of changes in the specific neuro-sensory system
Periodo de tiempo: baseline, 4 week, 12 week
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The following tests was evaluated during the follow-up period.
The pain intensity was evaluated by short-form McGill Pain Questionnaire and by sleep disturbance pain score.
The quantitative change of sensory nerve was evaluated by quantitative sensory test (QST).
We measure serum neuron-specific enolase (NSE), glucose, insulin and c-peptide.
The amount of drug requirements will also assess at each follow-up period.
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baseline, 4 week, 12 week
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The secondary effect of the procedure for the peripheral nerves and blood vessels
Periodo de tiempo: baseline, 12 week
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Michigan neuropathy screening instrument (MNSI) is used for screening for diabetic peripheral neuropathy.
Changes in patient's mood is assessed by the Beck Depression Inventory (BDI) system.
Electrophysiological tests are used in the evaluation of nerve conduct velocity.
Skin punch biopsy is used to evaluate the density of epidermal nerve fibers.
Improvement of blood flow in the peripheral veins is evaluated by ankle brachial index (ABI), pulse wave velocity (PWV) and digital arterial plethysmography.
We measure serum glucose, insulin ant c-peptide.
The amount of drug requirements will also assess at each follow-up period.
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baseline, 12 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Hye Seung Jung, Ph.D., Seoul Nation University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- mononuclear cell-based therapy
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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