Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.

Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.

Patrocinadores

Patrocinador principal: Wenzhou Medical University

Fuente Wenzhou Medical University
Resumen breve

This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy.

Descripción detallada

1. Autologous bone marrow stem cells (ABMSC) mobilization and harvest For harvesting more ABMSC, ABMSC mobilization is induced by recombinant human granulocyte colony stimulating factor (rhGCSF,Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before bone marrow puncture.

Bone marrow (160-200ml) of the patients is harvested from both posterior superior iliacs according to standard procedures under local anaesthesia and is collected in a plastic bag containing heparin.

2. Both treatment group and control group receive drugs therapy.

3. ABMSC separation and infusion ABMSC is separated and purified in a class 10,000 clean laboratory. After fat and bony particles are removed by filtration, collected cells are moved to a cell-processing device. The reagents adopt the method of negative cells collection. Take the cells which intended to remove as target cells, and carry out the removal step-by-step. On the basis of this method, red blood cells, blood platelets, blood plasma will be completely removed with part of white cells and lymphocytes being remarkably removed as well while all the stem cells / progenitor cells are being well retained.

The nucleated cell (white blood cell) count of final ABMSC is measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells is counted manually under a microscope by Wright-Giemsa stain method. Cell differentiation factor 34(CD34) positive cells were determined by flow cytometry analysis.

The time of ABMSC separation and purification is 2.5-3 hours. ABMSC is added to 10 ml saline and well mixed by shaking the vial gently. The catheter is pushed to reach the proper hepatic artery. The diameter of the catheter is 1.4mm, it is thin enough to easily been inserted to right gastric artery . The mixture of saline and ABMSC is infused into proper hepatic artery at uniform speed for about two minutes. The catheter is removed after the ABMSCi.

4. Statistical analysis - Categorical data are presented as absolute values and percentages, whereas continuous data are summarized as mean and Standard Deviation. Statistical analysis was performed using t-test for paired or unpaired samples. Time courses of measurements of liver function parameters were analyzed by repeated-measures ANOVA. The analysis is performed using the Statistic Package for Social Science (SPSS). All statistical analysis is based on two-tailed hypothesis tests with a significance level of p< 0.05.

Estado general Recruiting
Fecha de inicio October 2016
Fecha de Terminación October 2020
Fecha de finalización primaria October 2017
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change from baseline alanine aminotransferase at 6 months baseline and 6 months after treatment
Change from baseline aspartate aminotransferase at 6 months baseline and 6 months after treatment
Change from baseline total bilirubin at 6 months baseline and 6 months after treatment
Change from baseline direct bilirubin at 6 months baseline and 6 months after treatment
Change from baseline total bile acid at 6 months baseline and 6 months after treatment
Change from baseline albumin at 6 months baseline and 6 months after treatment
Change from baseline prothrombin time at 6 months baseline and 6 months after treatment
Change from baseline international normalized ratio at 6 months baseline and 6 months after treatment
Change from baseline white blood cell at 6 months baseline and 6 months after treatment
Change from baseline platelet at 6 months baseline and 6 months after treatment
Resultado secundario
Medida Periodo de tiempo
Change from baseline liver density at 6 months baseline and 6 months after treatment
Change from baseline liver size at 6 months baseline and 6 months after treatment
Change from baseline spleen thickness at 6 months baseline and 6 months after treatment
Incidence of adverse events that are related to treatment baseline and 6 months after treatment
Number of participants that survive without developing disease 12 months after treatment
Number of participants that survive with developing disease 12 months after treatment
Number of participants that die after treatment 12 months after treatment
Inscripción 40
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Autologous bone marrow stem cells infusion

Descripción: Autologous bone marrow stem cells are infused into proper hepatic artery

Etiqueta de grupo de brazo: treatment group: ABMSCi & drugs

Otro nombre: ABMSCi

Tipo de intervención: Drug

Nombre de intervención: drugs such as Ursodeoxycholic Acid tablets

Descripción: Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Otro nombre: UDCA

Elegibilidad

Criterios:

Inclusion Criteria:

1. Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect);

2. Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi;

3. Age between 18 and 60 years;

4. Abnormal liver function.

Exclusion Criteria:

1. Enlisted for liver transplantation

2. Diagnosis of hepatocellular carcinoma or other cancers

3. Other severe medical disease, and acute infection

4. pregnant or nursing females,co-infections with HIV ,serious bacterial infection

5. other vital organ or system dysfunction

6. with severe complications of liver cirrhosis

7. hematological disorder

Género: All

Edad mínima: 18 Years

Edad máxima: 60 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
yongping chen Study Chair First Affiliated Hospital of Wenzhou Medical University
Contacto general

Apellido: yongping chen

Teléfono: 8613505777281

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Copia de seguridad de contactos: Investigador: the First Affiliated Hospital of Wenzhou Medical University yongping chen 8613505777281 [email protected] yongping chen, MD Principal Investigator lanman xu, PhD Principal Investigator dazhi chen, MD Principal Investigator minghua zheng, PhD Principal Investigator keqing shi, MD Principal Investigator yu huang, MD Principal Investigator faling wu, MD Principal Investigator ruicong chen, MD Principal Investigator yunlei xiao, MD Principal Investigator
Ubicacion Paises

China

Fecha de verificación

October 2016

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Wenzhou Medical University

Nombre completo del investigador: yongping chen

Título del investigador: Director,Clinical Research

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: treatment group: ABMSCi & drugs

Tipo: Experimental

Descripción: ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Etiqueta: control group: drugs

Tipo: Active Comparator

Descripción: drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally

Acrónimo ABMSCIFTLD
Datos del paciente Undecided
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov