Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes (ASD2)

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT03343782

VinmecRISCGT70

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Stem cell transplantation

Experimental group

Description:

Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval

Treatment:

Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell