Type 1 Diabetes
Conditions
Keywords
Diabetes Adipose-derived mesenchymal stem cell
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.
Interventions
COMBINATION_PRODUCTadipose-derived messenchymal stem cell
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
Sponsors
Gwoxi Stem cell applied technology Company
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | up to the 6-month period following treatment | A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin |
| 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 |
| Insulin dose | up to the 6-month period following treatment | Insulin dose |
Countries
Vietnam
Outcome results
None listed