Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
- Conditions
- Type 1 Diabetes
- Interventions
- Combination Product: adipose-derived messenchymal stem cell
- Registration Number
- NCT05308836
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
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Patient diagnosed T1D (according to the instructions of the Ministry of Health No: 5481/QD-BYT dated December 30, 2020)
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Aged from 5 years and over.
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The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.
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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.
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At the time of screening at Vinmec for study enrollment, patients are actively managing their blood glucose levels with insulin.
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The patient does not have other serious acute illness requiring treatment
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The patient agrees to use stem cell transplant for treatment
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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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adipose-derived messenchymal stem cell (AD-MSC) adipose-derived messenchymal stem cell Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus.
- Primary Outcome Measures
Name Time Method Safety measure up to the 6-month period following treatment Safety is recognized as number of adverse events (AE) and serious adverse events (SAE) appear from the time that patients sign in ICF
- Secondary Outcome Measures
Name Time Method Fasting blood glucose (FPG) up to the 6-month period following treatment Fasting blood glucose (FPG) measures the levels of glucose (sugar) in the blood
C-peptide levels up to the 6-month period following treatment C-peptide levels
Blood insulin up to the 6-month period following treatment Blood insulin
HbA1c up to the 6-month period following treatment A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin
Insulin dose up to the 6-month period following treatment Insulin dose
Trial Locations
- Locations (1)
Vinmec Research Institute of Stem Cell and Gene Technology
🇻🇳Hanoi, Vietnam