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

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ClinicalTrials.gov Identifier: NCT03343782
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343782


Locations
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Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 10000
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology

Publications of Results:
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Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT03343782     History of Changes
Other Study ID Numbers: VinmecRISCGT70
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
Diabetes
BM mesenchymal stem cell
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases