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

Type 2 Diabetes Mellitus Clinical Trial

— ASD2  

Official title:

Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343782
• Other study ID #: VinmecRISCGT70
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: June 2024
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Combination Product:
• Expanded 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

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

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 effi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin dose	Reduction of insulin dose requirement by =50% in both groups	up to the 12-month period following treatment
Primary	Adverse events	Number of adverse events in both groups	up to the 12-month period following treatment
Secondary	Hemoglobin A1c (HbA1c) level	Improvement of HbA1c level as compared to baseline between two groups	up to the 12-month period following treatment