Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus

Detailed Description
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Bone marrow-derived mesenchymal stem cells have the immunosuppressive effect and secrete a variety of cytokines, improve the microenvironment of diabetic patients, targeting insulin resistance tissue, ameliorate the metabolic disorder of islet damage, protect and regeneration of the islet beta cells; reduce high blood sugar.The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in treatment 30 patients with type 2 diabetes mellitus at Vinmec International Hospital, Hanoi, Vietnam

Official Title
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Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females from 18 years and above. Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline. Type 2 diabetes duration 5 years or more. Before the screening, joint or combined with insulin, oral medications to treat more than 3 months. Who signed the informed consent form. Exclusion Criteria: Type 1 diabetes. Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc. According to the medical doctor's judgement, may endanger the safety of the subjects

Ages Eligible for Study
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Minimum Age: 18 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: Stem cell transplantation<br>Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval | Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell<br>* Collect bone marrow from lilac crest using local anaesthetic and syringe collection. Mesenchymal stem cell will be isolated, expanded and characterized in vitro under the GMP- grade procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dose | Reduction of insulin dose requirement by ≥50% in both groups | up to the 12-month period following treatment | 
| Adverse events | Number of adverse events in both groups | up to the 12-month period following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) level | Improvement of HbA1c level as compared to baseline between two groups | up to the 12-month period following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, BM mesenchymal stem cell