A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
MSC and PRP
Maladies Auto-immunes+5
+ Diabète Mellitus
+ Diabète sucré, Type 1
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2017
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.15 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 45 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site