Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes, BM mesenchymal stem cell
Brief summary
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
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
Interventions
COMBINATION_PRODUCTExpanded autologous bone marrow-derived mesenchymal stem cell
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
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males and females * Age 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin dose | up to the 12-month period following treatment | Reduction of insulin dose requirement by ≥50% in both groups |
| Adverse events | up to the 12-month period following treatment | Number of adverse events in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) level | up to the 12-month period following treatment | Improvement of HbA1c level as compared to baseline between two groups |
Countries
Vietnam
Outcome results
None listed