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NCT Number: NCT03343782

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 10000, Vietnam

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expanded autologous bone marrow-derived mesenchymal stem cell

Combination 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

Primary outcomes

  1. Insulin dose

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

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

  2. Adverse events

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

    Number of adverse events in both groups

Secondary outcomes

  1. Hemoglobin A1c (HbA1c) level

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

    Improvement of HbA1c level as compared to baseline between two groups

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Acronym: ASD2

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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