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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05308836
• Other study ID #: ISC20.01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 4, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology	Gwoxi Stem cell applied technology Company

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

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 A — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c	A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin	up to the 6-month period following treatment
Secondary	Fasting blood glucose (FPG)	Fasting blood glucose (FPG) measures the levels of glucose (sugar) in the blood	up to the 6-month period following treatment
Secondary	C-peptide levels	C-peptide levels	up to the 6-month period following treatment
Secondary	Blood insulin	Blood insulin	up to the 6-month period following treatment
Secondary	Insulin dose	Insulin dose	up to the 6-month period following treatment

External Links

•   Heterologous Adipose-Derived Mesenchymal Stem Cells and Vitamin D Supplementation in Patients with Recent-Onset Type 1 Diabetes Mellitus-Six Months Follow-Up