Type 2 Diabetes MellitusPhase 1/2T2DMNCT03943940
BM-MNCs and UC-MSCs Infusion for Type 2 Diabetes Mellitus Patients
A Phase 1/2 study testing BM-MNC and UC-MSC in people with Type 2 Diabetes Mellitus, run by Van Hanh General Hospital at 1 site in Vietnam.
Trial summary
The purpose of this study is to evaluate the preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients. 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?
- BM-MNC and UC-MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 24 Apr 2019to 30 Aug 2020
- 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
- Who is diagnosed with Type 2 Diabetes Mellitus according to the ADA 3 years or more
- Patients are able to read, write and understand ICF form and agree to participate in the study
- Males and females between age 18 and 70 years at the screening.
- FBG > 7 mmol/L
- 8% ≤ HbA1C ≤ 11%
- Fasting C-peptide > 0.6 ng/ml
- Anti GAD (-)
- The patient is treated by two oral diabetes medications but uncontrolled blood glucose (HbA1C ≥ 8%)
Who cannot join
- Pregnant women, planning to become pregnant and lactating women during the study period
- The patient has a disease or a history of vascular disease; history of abdominal or chest aortic disease;
- Patients are diagnosed with heart failure degree IV according to NYHA or kidney failure degree IV according to KDIGO;
- Patients with severe malignancy or dysplasia within 5 years prior to the study period or who are suffering from severe malignant or dysplasia
- Infection is undergoing antibiotic treatment or antibiotics have just been discontinued within 14 days
- Hematologic disease or coagulopathy
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- There are abnormalities in liver function (AST and/or ALT ≥ 2 times or bilirubin ≥ 2.0 times normal value at the time of screening);
- Patients with immunodeficiency diseases such as HIV or hepatitis B and C;
- Acute or chronic pancreatitis or a history of acute pancreatitis;
- Patients taking immunosuppressive drugs (such as azathioprine, methotrexate) within 6 months before the study time or taking immunosuppressive drugs;
- The patient is unable to complete the study;
- The patient is participating in another study.
Trial locations and contacts
1 site in 1 country.
StemCellUnit VanHanh contact
Vietnam1 site, 1 recruiting
- Recruiting
Van Hanh General Hospital
Ho Chi Minh City, Ho Chi Minh, 700000
Phuong Thi-Bich Le, MSc-MD, 902742732 ext. +84, drbphuong@gmail.com
About this study
Official title: A Preliminary Safety and Efficacy Evaluation of Bone Marrow Mononuclear Cells (BM-MNCs) and Umbilical Cord Tissue-derived Mesenchymal Stem Cells (UC-MSC) Infusion for Type 2 Diabetes Mellitus (T2DM) Patients
The purpose of this study is to evaluate the preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients.
Read the detailed description
Mononuclear cells are collected from autologous bone marrow and allogeneic mesenchymal stem cells are isolated and cultured from umbilical cord tissues.
30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cell and mesenchymal stem cell by intravenous infusion and followed up for 6 months. The other 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines, which would be used as the control group.
Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments.
The primary endpoint is to assess the improvement of patient's C-peptid and HOMA-β, HOMA-IR, cytokines TNF-α, IL-1β, Blood glucose level, Hemoglobin A1c (HbA1c) level.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BM-MNC and UC-MSC, Control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MNC and UC-MSCBiological
Autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) under sterile conditions to treat this disease.
UC-MSC: 1-2 x 10^6 cells/kg
ControlOther
Standard medicine
| Study group | Role | What they receive |
|---|---|---|
| BM-MNC and UC-MSC | Experimental | 30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion. Receives: Biological: BM-MNC and UC-MSC |
| Stand medicines | Other | 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of C-peptid and HOMA-β
Assess the changes in C-peptid and HOMA-β level after transplantation
Measured: enrollment, 1 month, 3 months and 6 months after transplantation
The level of HOMA-IR and cytokines TNF-α, IL-1β
Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation
Measured: enrollment, 1 month, 3 months and 6 months after transplantation
Blood glucose level
Assess the changes in Blood glucose level after transplantation
Measured: enrollment, 1 month, 3 months and 6 months after transplantation
Hemoglobin A1c (HbA1c) level
Assess the changes in HbA1C level after transplantation
Measured: enrollment, 1 month, 3 months and 6 months after transplantation
Adverse events
Number of adverse events in both groups
Measured: during the course of 6 months
Secondary outcomes (1)
Insulin dose and drug dosage
Assess the changes in Insulin dose and drug dosage after transplantation
Measured: enrollment, 1 month, 3 months and 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start24 Apr 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Hanh General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phuong Thi-Bich Le, MSc-MD, Principal investigator, Stem Cell Unit, Van Hanh General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943940
- Sponsor's protocol ID
- TNLS012019-TBG
- Acronym
- T2DM
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Safety and Efficacy Evaluation of Bone Marrow Mononuclear Cells (BM-MNCs) and Umbilical Cord Tissue-derived Mesenchymal Stem Cells (UC-MSC) Infusion for Type 2 Diabetes Mellitus (T2DM) Patients
- ClinicalTrials.gov ID
- NCT03943940
- Acronym / sponsor ID
- T2DM / TNLS012019-TBG
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Van Hanh General HospitalUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 9 May 2019 (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 preliminary safety and efficacy of autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) infusion in type 2 Diabetes Mellitus patients.
Detailed description
Mononuclear cells are collected from autologous bone marrow and allogeneic mesenchymal stem cells are isolated and cultured from umbilical cord tissues.
30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cell and mesenchymal stem cell by intravenous infusion and followed up for 6 months. The other 30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines, which would be used as the control group.
Safety is to assess the occurrence of adverse events (AEs) during either stem cells infusion or by physician assessments.
The primary endpoint is to assess the improvement of patient's C-peptid and HOMA-β, HOMA-IR, cytokines TNF-α, IL-1β, Blood glucose level, Hemoglobin A1c (HbA1c) level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BM-MNC and UC-MSC | Experimental | Biological: BM-MNC and UC-MSC30 patients with Type 2 Diabetes Mellitus will be enrolled and received mononuclear cells and mesenchymal stem cells by intravenous infusion. |
| Stand medicines | Other | Other: Control30 patients with Type 2 Diabetes Mellitus will be enrolled and treated by standard medicines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Who is diagnosed with Type 2 Diabetes Mellitus according to the ADA 3 years or more
- Patients are able to read, write and understand ICF form and agree to participate in the study
- Males and females between age 18 and 70 years at the screening.
- FBG > 7 mmol/L
- 8% ≤ HbA1C ≤ 11%
Key exclusion criteria (12 listed)
- Pregnant women, planning to become pregnant and lactating women during the study period
- The patient has a disease or a history of vascular disease; history of abdominal or chest aortic disease;
- Patients are diagnosed with heart failure degree IV according to NYHA or kidney failure degree IV according to KDIGO;
- Patients with severe malignancy or dysplasia within 5 years prior to the study period or who are suffering from severe malignant or dysplasia
- Infection is undergoing antibiotic treatment or antibiotics have just been discontinued within 14 days
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 |
|---|---|---|
| BM-MNC and UC-MSCAutologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) under sterile conditions to treat this disease. UC-MSC: 1-2 x 10^6 cells/kg | Biological | BM-MNC and UC-MSC |
| ControlStandard medicine | Other | Stand medicines |
Primary outcome
The level of C-peptid and HOMA-β
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in C-peptid and HOMA-β level after transplantation
The level of HOMA-IR and cytokines TNF-α, IL-1β
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in HOMA-IR and cytokines TNF-α, IL-1β level after transplantation
Blood glucose level
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in Blood glucose level after transplantation
Hemoglobin A1c (HbA1c) level
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Assess the changes in HbA1C level after transplantation
Adverse events
Time frame: during the course of 6 months
Number of adverse events in both groups
1 secondary outcome
Insulin dose and drug dosage
Time frame: enrollment, 1 month, 3 months and 6 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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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.
StemCellUnit VanHanh contact
Phuong Thi-Bich Le, MSc-MD principal investigator
Stem Cell Unit, Van Hanh General Hospital
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 BM-MNC and UC-MSC in people with Type 2 Diabetes Mellitus, run by Van Hanh General Hospital 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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phuong Thi-Bich Le, MSc-MD (902742732 ext. +84, drbphuong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of C-peptid and HOMA-β (time frame: enrollment, 1 month, 3 months and 6 months after transplantation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2019; AzTrials last refreshed its copy on 4 Nov 2026.