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Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes (ASD2)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
Expanded autologous bone marrow-derived mesenchymal 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 2 Diabetes Mellitus focused on measuring Diabetes, BM mesenchymal stem cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females from 18 years and above.
  • Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline.
  • Type 2 diabetes duration 5 years or more.
  • Before the screening, joint or combined with insulin, oral medications to treat more than 3 months.
  • Who signed the informed consent form.

Exclusion Criteria:

  • Type 1 diabetes.
  • Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc.
  • According to the medical doctor's judgement, may endanger the safety of the subjects

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene Technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell transplantation

Arm Description

Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval

Outcomes

Primary Outcome Measures

Insulin dose
Reduction of insulin dose requirement by ≥50% in both groups
Adverse events
Number of adverse events in both groups

Secondary Outcome Measures

Hemoglobin A1c (HbA1c) level
Improvement of HbA1c level as compared to baseline between two groups

Full Information

First Posted
November 12, 2017
Last Updated
June 14, 2021
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03343782
Brief Title
Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes
Acronym
ASD2
Official Title
Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology

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 and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus
Detailed Description
Bone marrow-derived mesenchymal stem cells have the immunosuppressive effect and secrete a variety of cytokines, improve the microenvironment of diabetic patients, targeting insulin resistance tissue, ameliorate the metabolic disorder of islet damage, protect and regeneration of the islet beta cells; reduce high blood sugar.The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in treatment 30 patients with type 2 diabetes mellitus 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 2 Diabetes Mellitus
Keywords
Diabetes, BM mesenchymal stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell transplantation
Arm Type
Experimental
Arm Description
Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval
Intervention Type
Combination Product
Intervention Name(s)
Expanded autologous bone marrow-derived mesenchymal stem cell
Intervention Description
Collect bone marrow from lilac crest using local anaesthetic and syringe collection. Mesenchymal stem cell will be isolated, expanded and characterized in vitro under the GMP- grade procedure
Primary Outcome Measure Information:
Title
Insulin dose
Description
Reduction of insulin dose requirement by ≥50% in both groups
Time Frame
up to the 12-month period following treatment
Title
Adverse events
Description
Number of adverse events in both groups
Time Frame
up to the 12-month period following treatment
Secondary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c) level
Description
Improvement of HbA1c level as compared to baseline between two groups
Time Frame
up to the 12-month period following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females from 18 years and above. Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline. Type 2 diabetes duration 5 years or more. Before the screening, joint or combined with insulin, oral medications to treat more than 3 months. Who signed the informed consent form. Exclusion Criteria: Type 1 diabetes. Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc. According to the medical doctor's judgement, may endanger the safety of the subjects
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34080789
Citation
Nguyen LT, Hoang DM, Nguyen KT, Bui DM, Nguyen HT, Le HTA, Hoang VT, Bui HTH, Dam PTM, Hoang XTA, Ngo ATL, Le HM, Phung NY, Vu DM, Duong TT, Nguyen TD, Ha LT, Bui HTP, Nguyen HK, Heke M, Bui AV. Type 2 diabetes mellitus duration and obesity alter the efficacy of autologously transplanted bone marrow-derived mesenchymal stem/stromal cells. Stem Cells Transl Med. 2021 Sep;10(9):1266-1278. doi: 10.1002/sctm.20-0506. Epub 2021 Jun 3.
Results Reference
result

Learn more about this trial

Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes

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