Type 1 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.
Detailed description
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.
Interventions
BIOLOGICALMSC and PRP
MSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease.
Sponsors
University of Science Ho Chi Minh City
Van Hanh General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | every month in the course of 6 months | Assess the changes in fasting blood glucose level after transplantation |
| Hemoglobin A1c (HbA1c) level | 1 month, 3 months and 6 months after transplantation | Assess the changes in HbA1C level after transplantation |
| Adverse events | during the course of 6 months | Evaluate the safety of therapy by number record of adverse events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin dose | during the course of 6 months | Reduction of insulin dose after transplantation |
| C-peptide | every month in the course of 6 months | Assess the improvement in C-peptide level after transplantation |
| Blood insulin level | every month in the course of 6 months | Assess the changes in blood insulin level after transplantation |
Countries
Vietnam
Contacts
Primary ContactPhuong Le, MSc-MD
Backup ContactStem Cell Unit, Van Hanh General Hospital
Outcome results
None listed