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

NCT05308836 | Completed Phase 1 DMC

• 1 other identifier: ISC20.01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Conditions

Type 1 Diabetes

Keywords

Diabetes Adipose-derived mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• HbA1c

  up to the 6-month period following treatment

• Fasting blood glucose (FPG)

  up to the 6-month period following treatment

• C-peptide levels

  up to the 6-month period following treatment

• Blood insulin

  up to the 6-month period following treatment

• Insulin dose

  up to the 6-month period following treatment

Study Arms (1)

Adipose-derived messenchymal stem cell (AD-MSC)

EXPERIMENTAL

Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus.

Combination Product: adipose-derived messenchymal stem cell

Interventions

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

Adipose-derived messenchymal stem cell (AD-MSC)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead
• Gwoxi Stem cell applied technology Company: collaborator

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 10000, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 32010488 BACKGROUND

• 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.

  PMID: 32582156 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Liem T Nguyen, Prof

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: April 4, 2022
• Study Start: May 4, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)