A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
MSC and PRP
Enfermedades del Sistema Endocrino+4
+ Enfermedades Autoinmunes
+ Diabetes Mellitus
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2017
Fecha en la que se inscribió al primer participante.Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (UC-MSC). 15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by intravenous infusion. They were followed up for 6 months after transplantation. Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments. The primary endpoint is to assess the improvement of patients' Fasting blood glucose, HbA1C, C-peptide, and blood insulin level.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 15 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 45 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria: * At least one autoantibody associated with Type 1 Diabetes Mellitus such as ICA or GAD. * Previously diagnosed at a medical facility with Type 1 Diabetes. * Having evidence of insulin depletion based on the test results during screening. * Patients treated with fixed insulin dose for at least 3 months. * Males and females between age 18 and 45 years at the screening. * Patients able to read, write and understand ICF form Exclusion Criteria: * Uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmHg and/or diastolic blood pressure \> 100 mmHg. * Having evidence related to renal dysfunction: * creatinine \> 1.5 mg/dl or (\>133 mmol/L) for men. * creatinine \> 1.4 mg/dl or (\>124 mmol/L) for woman. * eGRF \< 40 ml/ min * Proteinuria \> 300 mg/day * Having evidence of ketoacidosis at the time of selection. * Having evidence of ongoing or frequent hypoglycemia. * Having severe infection * Infected with hepatitis B virus or hepatitis C or tuberculosis. Positive results of HbsAg or Anti HCV or/and PCR tuberculosis are only acceptable in case of vaccination and without suspicious signs. All other cases are not accepted even in the absence of clinical signs. * Diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism. * Having abnormalities in red blood cells such as sickle cells disease. * Using alcohol and/or tobacco. * Blood clotting disorders (INR \> 1.5, PTT \>40, PT \> 15). * Taking any anticoagulant. * Taking systemic steroids. * Participate in another clinical study involving experimenting drugs and/or medical equipment. * Patients who are unable to perform the tests and assessments needed for the study (eg, patients who are unable to perform bone marrow transplantation) or patients who do not agree to participate in the study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación