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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 June 2021 |
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Main ID: |
NCT03343782 |
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Date of registration:
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12/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes
ASD2 |
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Scientific title:
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Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes |
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Date of first enrolment:
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November 1, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03343782 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Vietnam
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell
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Primary Outcome(s)
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Adverse events
[Time Frame: up to the 12-month period following treatment]
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Insulin dose
[Time Frame: up to the 12-month period following treatment]
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Secondary Outcome(s)
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Hemoglobin A1c (HbA1c) level
[Time Frame: up to the 12-month period following treatment]
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Secondary ID(s)
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VinmecRISCGT70
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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