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Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

NCT05308836•Vinmec Research Institute of Stem Cell and Gene Technology

View on ClinicalTrials.gov

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.

Eligibility

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam

Key Dates

Start Date

May 4, 2021

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2024

Last Updated

August 17, 2025

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes

Interventions

adipose-derived messenchymal stem cell

COMBINATION_PRODUCT

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

NCT05188027

Type 1 DiabetesPost-menopause

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Dysautonomia in Children With Type 1 Diabetes

Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes

Lipoprotein Kinetics in T1D

Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery