Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

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.

Inclusion Criteria:

• Patient diagnosed T1D (according to the instructions of the Ministry of Health No: 5481/QD-BYT dated December 30, 2020)

• Aged from 5 years and over.

• The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.

• Blood testing conducted at the time of diagnosis:

  • Fasting blood glucose ≥ 7 mmol / L,
  • HbA1C ≥ 6.5%.
  • Have at least one antibodies associated with T1D such as ICA; GAD; ZnT8 or IAA.

• At the time of screening at Vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin.

• The patient does not have other serious acute illness requiring treatment

• The patient agrees to use stem cell transplant for treatment

• The patient's parent (parent or legal guardian) can read, write, understand the ICF form and agree to sign a consent to participate in the study.

Exclusion Criteria:

• Having evidence related to renal dysfunction: creatinine > 1.5 mg/dl or (>133 mmol/L) for boys, creatinine > 1.4 mg/dl or (>124 mmol/L) for girls
• In case of kidney failure. Proteinuria within the range of nephrotic syndrome (>3.5 g/day or ratio of protein/creatinine in urine >2.7)
• In case of kidney failure
• Having severe infection or infected with hepatitis B virus, hepatitis C virus, HIV virus, or tuberculosis
• Cardiovascular disease, respiratory disease (pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer or neurological disease
• Blood clotting disorders (INR> 1,5, PTT> 40, PT> 15).
• Taking any anticoagulant
• Taking systemic steroids
• Participate in another clinical study involving experimenting drugs and/or medical equipment
• History of allergic reaction to anesthetic agents and/or antibiotics