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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
adipose-derived messenchymal stem cell
Sponsored by
Vinmec Research Institute of Stem Cell and Gene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Diabetes Adipose-derived mesenchymal stem cell

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.
  • 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

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adipose-derived messenchymal stem cell (AD-MSC)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HbA1c
A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin
Fasting blood glucose (FPG)
Fasting blood glucose (FPG) measures the levels of glucose (sugar) in the blood
C-peptide levels
C-peptide levels
Blood insulin
Blood insulin
Insulin dose
Insulin dose

Full Information

First Posted
February 25, 2022
Last Updated
March 31, 2022
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
Collaborators
Gwoxi Stem cell applied technology Company
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1. Study Identification

Unique Protocol Identification Number
NCT05308836
Brief Title
Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Official Title
Phase I Open Label Clinical Trial to Evaluate Safety of Adipose Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
Collaborators
Gwoxi Stem cell applied technology Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Diabetes Adipose-derived mesenchymal stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adipose-derived messenchymal stem cell (AD-MSC)
Arm Type
Experimental
Arm Description
Intervention: Intravenousling (IV) AD-MSC in 10 patients with type 1 diabetes mellitus.
Intervention Type
Combination Product
Intervention Name(s)
adipose-derived messenchymal stem cell
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety measure
Description
Safety is recognized as number of adverse events (AE) and serious adverse events (SAE) appear from the time that patients sign in ICF
Time Frame
up to the 6-month period following treatment
Secondary Outcome Measure Information:
Title
HbA1c
Description
A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin
Time Frame
up to the 6-month period following treatment
Title
Fasting blood glucose (FPG)
Description
Fasting blood glucose (FPG) measures the levels of glucose (sugar) in the blood
Time Frame
up to the 6-month period following treatment
Title
C-peptide levels
Description
C-peptide levels
Time Frame
up to the 6-month period following treatment
Title
Blood insulin
Description
Blood insulin
Time Frame
up to the 6-month period following treatment
Title
Insulin dose
Description
Insulin dose
Time Frame
up to the 6-month period following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liem T Liem, Prof
Phone
0986565015
Email
v.liemnt@vinmec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kien T Nguyen, MsC
Phone
0386958552
Email
v.kiennt25@vinmec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, Prof
Organizational Affiliation
Vinmec Research Institute of Stem Cell and Gene Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liem T Nguyen, Prof
Phone
(+84 4) 3 974 3556
Ext
1420
Email
v.liemnt@vinmec.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32010488
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.
Results Reference
result
PubMed Identifier
32582156
Citation
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.
Results Reference
result
Links:
URL
https://diabetesjournals.org/diabetes/article/67/Supplement_1/1112-P/54170/Heterologous-Adipose-Derived-Mesenchymal-Stem
Description
Heterologous Adipose-Derived Mesenchymal Stem Cells and Vitamin D Supplementation in Patients with Recent-Onset Type 1 Diabetes Mellitus-Six Months Follow-Up

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

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