A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
MSC and PRP
Autoimmune Diseases+5
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Treatment Study
Summary
Study start date: April 1, 2017
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location