Type 2 Diabetes MellitusPhase 1/2ASD2NCT03343782
Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type II Diabetes
A Phase 1/2 study testing Expanded autologous bone marrow-derived mesenchymal stem cell in people with Type 2 Diabetes Mellitus, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Expanded autologous bone marrow-derived mesenchymal stem cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Nov 2017to 1 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 10000
About this study
Official title: Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
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
Read the 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
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Expanded autologous bone marrow-derived mesenchymal stem cell
- Keywords
- Diabetes, BM mesenchymal stem cell
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded autologous bone marrow-derived mesenchymal stem cellCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Stem cell transplantation | Experimental | Intervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval Receives: Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin dose
Reduction of insulin dose requirement by ≥50% in both groups
Measured: up to the 12-month period following treatment
Adverse events
Number of adverse events in both groups
Measured: up to the 12-month period following treatment
Secondary outcomes (1)
Hemoglobin A1c (HbA1c) level
Improvement of HbA1c level as compared to baseline between two groups
Measured: up to the 12-month period following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343782
- Sponsor's protocol ID
- VinmecRISCGT70
- Acronym
- ASD2
- Status last verified
- Jun 2024
- First submitted
- 12 Nov 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34080789
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03343782
- Acronym / sponsor ID
- ASD2 / VinmecRISCGT70
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, BM mesenchymal stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell transplantation | Experimental | Combination Product: Expanded autologous bone marrow-derived mesenchymal stem cellIntervention: 30 patients will be transplanted autologous bone marrow-derived mesenchymal stem cells and undergoing 2 treatment with 6 months interval |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded autologous bone marrow-derived mesenchymal stem cellCollect 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 | Combination product | Stem cell transplantation |
Primary outcome
Insulin dose
Time frame: up to the 12-month period following treatment
Reduction of insulin dose requirement by ≥50% in both groups
Adverse events
Time frame: up to the 12-month period following treatment
Number of adverse events in both groups
1 secondary outcome
Hemoglobin A1c (HbA1c) level
Time frame: up to the 12-month period following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Results publication: PubMed 34080789Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Expanded autologous bone marrow-derived mesenchymal stem cell in people with Type 2 Diabetes Mellitus, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin dose (time frame: up to the 12-month period following treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.