The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in patients with type 1 diabetes mellitus (T1D)
Adipose derived mesenchymal stem cells (AD-MSCs) has many advantages, i.e. the greater ease of access and harvesting by means such as subcutaneous lipoaspiration, a much less painful procedure than harvesting bone marrow stem cells, and a much less ethical concern because they are harvested from autologous fat. The purpose of this study is to evaluate the safety of intravenously (IV) administered adipose-derived mesenchymal stem cell (AD-MSC) in treatment 10 patients with type 1 diabetes mellitus (T1D) at Vinmec International Hospital, Hanoi, Vietnam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Collaborative research program between Vinmec Research Institute of Stem Cell and Gene Technology with the National Yang-Ming University in Taiwan The adipose mesenchymal stem cell line (GXIPC1) was collected from healthy donors who have screened for infectious diseases and then multiplied in large numbers. These products were produced following the GMP laboratory system and approved by Taiwan FDA for preclinical and clinical trials with completed certificates
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam
Safety measure
Safety is recognized as number of adverse events (AE) and serious adverse events (SAE) appear from the time that patients sign in ICF
Time frame: up to the 6-month period following treatment
HbA1c
A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin
Time frame: up to the 6-month period following treatment
Fasting blood glucose (FPG)
Fasting blood glucose (FPG) measures the levels of glucose (sugar) in the blood
Time frame: up to the 6-month period following treatment
C-peptide levels
C-peptide levels
Time frame: up to the 6-month period following treatment
Blood insulin
Blood insulin
Time frame: up to the 6-month period following treatment
Insulin dose
Insulin dose
Time frame: up to the 6-month period following treatment
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