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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Combination Product: adipose-derived messenchymal stem cell


Participation Criteria
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Eligibility Criteria
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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. Be within 12 months of diagnosis with T1D Blood test: Fasting blood glucose > 7 mmol / L, 7,5% < HbA1C <10%. Have at least one antibodies associated with T1D such as ICA or GAD 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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose-derived messenchymal stem cell (AD-MSC)<br>Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus. | Combination Product: adipose-derived messenchymal stem cell<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to the 6-month period following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin | 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 | up to the 6-month period following treatment | 
| C-peptide levels | C-peptide levels | up to the 6-month period following treatment | 
| Blood insulin | Blood insulin | up to the 6-month period following treatment | 
| Insulin dose | Insulin dose | up to the 6-month period following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Adipose-derived mesenchymal stem cell