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

August 12, 2025 updated by: Vinmec Research Institute of Stem Cell and Gene Technology

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 10000
        • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adipose-derived messenchymal stem cell (AD-MSC)
Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus.
Combination product: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measure
Time Frame: 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
up to the 6-month period following treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: up to the 6-month period following treatment
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)
Time Frame: up to the 6-month period following treatment
Fasting blood glucose (FPG) measures the levels of glucose (sugar) in the blood
up to the 6-month period following treatment
C-peptide levels
Time Frame: up to the 6-month period following treatment
C-peptide levels
up to the 6-month period following treatment
Blood insulin
Time Frame: up to the 6-month period following treatment
Blood insulin
up to the 6-month period following treatment
Insulin dose
Time Frame: up to the 6-month period following treatment
Insulin dose
up to the 6-month period following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Collaborators

Gwoxi Stem cell applied technology Company

Investigators

  • Principal Investigator: Liem T Nguyen, Prof, Vinmec Research Institute of Stem Cell and Gene Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISC20.01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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