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

Vinmec Research Institute of Stem Cell and Gene Technology30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Expanded autologous bone marrow-derived mesenchymal stem cellCOMBINATION_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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Outcomes

Primary Outcomes

Insulin dose

Reduction of insulin dose requirement by ≥50% in both groups

Time frame: up to the 12-month period following treatment

Adverse events

Number of adverse events in both groups

Time frame: up to the 12-month period following treatment

Secondary Outcomes

Hemoglobin A1c (HbA1c) level

Improvement of HbA1c level as compared to baseline between two groups

Time frame: up to the 12-month period following treatment

Data from ClinicalTrials.gov

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