Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Biological: MSC and PRP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC and PRP<br>15 patients will be given autologous bone marrow-derived mesenchymal stem cells (BM-MSC) and mesenchymal stem cell from allogeneic umbilical cord tissue (UC-MSC) combined with platelet-rich plasma (PRP) by intravenous infusion. | Biological: MSC and PRP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | Assess the changes in fasting blood glucose level after transplantation | every month in the course of 6 months | 
| Hemoglobin A1c (HbA1c) level | Assess the changes in HbA1C level after transplantation | 1 month, 3 months and 6 months after transplantation | 
| Adverse events | Evaluate the safety of therapy by number record of adverse events (AEs) | during the course of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dose | Reduction of insulin dose after transplantation | during the course of 6 months | 
| C-peptide | Assess the improvement in C-peptide level after transplantation | every month in the course of 6 months | 
| Blood insulin level | Assess the changes in blood insulin level after transplantation | every month in the course of 6 months |