Status:
COMPLETED
Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Collaborating Sponsors:
Gwoxi Stem cell applied technology Company
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
5+ years
Phase:
PHASE1
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 ha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05308836
Start Date
May 4 2021
End Date
December 30 2024
Last Update
August 17 2025
Active Locations (1)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 10000