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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell

• Registration Number: NCT03343782
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

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

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-12
• Study First Posted: 2017-11-17
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell transplantation	Expanded autologous bone marrow-derived mesenchymal stem cell	Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval

Primary Outcome Measures

Name	Time	Method
Adverse events	up to the 12-month period following treatment	Number of adverse events in both groups
Insulin dose	up to the 12-month period following treatment	Reduction of insulin dose requirement by ≥50% in both groups

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c (HbA1c) level	up to the 12-month period following treatment	Improvement of HbA1c level as compared to baseline between two groups

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam