Clinical trial
Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Name
ISC20.01
Description
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)
Trial arms
Trial start
2021-05-04
Estimated PCD
2024-12-30
Trial end
2024-12-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
adipose-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
Arms:
Adipose-derived messenchymal stem cell (AD-MSC)
Size
10
Primary endpoint
Safety measure
up to the 6-month period following treatment
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.
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2024-06-04
1 organization
1 product
1 indication
Indication
Type 1 Diabetes