Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes
ASD2
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Nov 2017
Longer than P75 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 12, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJune 4, 2024
June 1, 2024
1.7 years
November 12, 2017
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insulin dose
Reduction of insulin dose requirement by ≥50% in both groups
up to the 12-month period following treatment
Adverse events
Number of adverse events in both groups
up to the 12-month period following treatment
Secondary Outcomes (1)
Hemoglobin A1c (HbA1c) level
up to the 12-month period following treatment
Study Arms (1)
Stem cell transplantation
EXPERIMENTALIntervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval
Interventions
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
Eligibility Criteria
You may qualify if:
- Males and females
- Age 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 10000, Vietnam
Related Publications (1)
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.
PMID: 34080789RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
November 12, 2017
First Posted
November 17, 2017
Study Start
November 1, 2017
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
June 4, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share