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| Name | Class |
|---|---|
| Gwoxi Stem cell applied technology Company | UNKNOWN |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose-derived messenchymal stem cell (AD-MSC) | Experimental | Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adipose-derived messenchymal stem cell | Combination Product | 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 |
| 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 |
| 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 |
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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.
The time from the diagnosis of type 1 diabetes to enrollment ≤ 12 months.
Blood testing conducted at the time of diagnosis:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Liem T Nguyen, Prof | Vinmec Research Institute of Stem Cell and Gene Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | 10000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32010488 | Result | Zhang Y, Chen W, Feng B, Cao H. The Clinical Efficacy and Safety of Stem Cell Therapy for Diabetes Mellitus: A Systematic Review and Meta-Analysis. Aging Dis. 2020 Feb 1;11(1):141-153. doi: 10.14336/AD.2019.0421. eCollection 2020 Feb. | |
| 32582156 | Result | Araujo DB, Dantas JR, Silva KR, Souto DL, Pereira MFC, Moreira JP, Luiz RR, Claudio-Da-Silva CS, Gabbay MAL, Dib SA, Couri CEB, Maiolino A, Rebelatto CLK, Daga DR, Senegaglia AC, Brofman PRS, Baptista LS, Oliveira JEP, Zajdenverg L, Rodacki M. Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study. Front Immunol. 2020 Jun 2;11:993. doi: 10.3389/fimmu.2020.00993. eCollection 2020. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |