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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell transplantation | Experimental | Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expanded autologous bone marrow-derived mesenchymal stem cell | Combination Product | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | 10000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34080789 | Result | Nguyen LT, Hoang DM, Nguyen KT, Bui DM, Nguyen HT, Le HTA, Hoang VT, Bui HTH, Dam PTM, Hoang XTA, Ngo ATL, Le HM, Phung NY, Vu DM, Duong TT, Nguyen TD, Ha LT, Bui HTP, Nguyen HK, Heke M, Bui AV. Type 2 diabetes mellitus duration and obesity alter the efficacy of autologously transplanted bone marrow-derived mesenchymal stem/stromal cells. Stem Cells Transl Med. 2021 Sep;10(9):1266-1278. doi: 10.1002/sctm.20-0506. Epub 2021 Jun 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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