Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety measure
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Safety measure
Time Frame: 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 Outcomes
- Fasting blood glucose (FPG)(up to the 6-month period following treatment)
- C-peptide levels(up to the 6-month period following treatment)
- Blood insulin(up to the 6-month period following treatment)
- HbA1c(up to the 6-month period following treatment)
- Insulin dose(up to the 6-month period following treatment)