Type 1 Diabetes MellitusPhase 1/2NCT03484741
Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients
A Phase 1/2 study testing MSC and PRP in people with Type 1 Diabetes Mellitus, run by Van Hanh General Hospital at 1 site in Vietnam.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- MSC and PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2017to Nov 2018
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria:
- At least one autoantibody associated with Type 1 Diabetes Mellitus such as ICA or GAD.
- Previously diagnosed at a medical facility with Type 1 Diabetes.
- Having evidence of insulin depletion based on the test results during screening.
- Patients treated with fixed insulin dose for at least 3 months.
- Males and females between age 18 and 45 years at the screening.
- Patients able to read, write and understand ICF form
Who cannot join
- Uncontrolled blood pressure at the time of enrollment: systolic pressure >160 mmHg and/or diastolic blood pressure > 100 mmHg.
- Having evidence related to renal dysfunction:
- creatinine > 1.5 mg/dl or (>133 mmol/L) for men.
- creatinine > 1.4 mg/dl or (>124 mmol/L) for woman.
- eGRF < 40 ml/ min
- Proteinuria > 300 mg/day
Show all 18Show fewer
- Having evidence of ketoacidosis at the time of selection.
- Having evidence of ongoing or frequent hypoglycemia.
- Having severe infection
- Infected with hepatitis B virus or hepatitis C or tuberculosis. Positive results of HbsAg or Anti HCV or/and PCR tuberculosis are only acceptable in case of vaccination and without suspicious signs. All other cases are not accepted even in the absence of clinical signs.
- Diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism.
- Having abnormalities in red blood cells such as sickle cells disease.
- Using alcohol and/or tobacco.
- 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.
- Patients who are unable to perform the tests and assessments needed for the study (eg, patients who are unable to perform bone marrow transplantation) or patients who do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country.
Stem Cell Unit, Van Hanh General Hospital contact
Vietnam1 site, 1 recruiting
- Recruiting
Van Hanh Geral Hospital
Ho Chi Minh City, Ho Chi Minh, 700000
Phuong Le, MSc-MD, (+84)902742732, drbphuong@gmail.com
About this study
Official title: A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.
Read the detailed description
Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (UC-MSC).
15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by intravenous infusion. They were followed up for 6 months after transplantation.
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 patients' Fasting blood glucose, HbA1C, C-peptide, and blood insulin level.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- MSC and PRP
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC and PRPBiological
MSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease.
| Study group | Role | What they receive |
|---|---|---|
| MSC and PRP | Experimental | 15 patients will be given autologous bone marrow-derived mesenchymal stem cells (BM-MSC) and mesenchymal stem cell from allogeneic umbilical cord tissue (UC-MSC) combined with platelet-rich plasma (PRP) by intravenous infusion. Receives: Biological: MSC and PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Assess the changes in fasting blood glucose level after transplantation
Measured: every month in the course of 6 months
Hemoglobin A1c (HbA1c) level
Assess the changes in HbA1C level after transplantation
Measured: 1 month, 3 months and 6 months after transplantation
Adverse events
Evaluate the safety of therapy by number record of adverse events (AEs)
Measured: during the course of 6 months
Secondary outcomes (3)
Insulin dose
Reduction of insulin dose after transplantation
Measured: during the course of 6 months
C-peptide
Assess the improvement in C-peptide level after transplantation
Measured: every month in the course of 6 months
Blood insulin level
Assess the changes in blood insulin level after transplantation
Measured: every month in the course of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Apr 2017
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Hanh General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Science Ho Chi Minh City
- Responsible party
- Sponsor
- Investigators
- Phuong Le, MSc-MD, Principal investigator, Stem Cell Unit, Van Hanh General HospitalNgoc Phan, MSc, Principal investigator, Stem Cell Institute, University of Science Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484741
- Sponsor's protocol ID
- DIME 1001
- Other IDs
- DIME 1001
- Status last verified
- Apr 2018
- First submitted
- 16 Mar 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients
- ClinicalTrials.gov ID
- NCT03484741
- Acronym / sponsor ID
- DIME 1001
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Van Hanh General HospitalUniversity, hospital or other
- Collaborators
- University of Science Ho Chi Minh City
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Apr 2018 (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 efficacy of mesenchymal stem cells (MSCs) transplantation for type 1 Diabetes Mellitus patients.
Detailed description
Mesenchymal stem cells (MSCs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (UC-MSC).
15 patients with type 1 Diabetes Mellitus will be enrolled and will receive MSCs by intravenous infusion. They were followed up for 6 months after transplantation.
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 patients' Fasting blood glucose, HbA1C, C-peptide, and blood insulin level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSC and PRP | Experimental | Biological: MSC and PRP15 patients will be given autologous bone marrow-derived mesenchymal stem cells (BM-MSC) and mesenchymal stem cell from allogeneic umbilical cord tissue (UC-MSC) combined with platelet-rich plasma (PRP) by intravenous infusion. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Who is diagnosed with Type 1 Diabetes Mellitus according to the ADA, the patients meet at least one of the following criteria:
- Patients treated with fixed insulin dose for at least 3 months.
- Males and females between age 18 and 45 years at the screening.
- Patients able to read, write and understand ICF form
Key exclusion criteria (18 listed)
- Uncontrolled blood pressure at the time of enrollment: systolic pressure >160 mmHg and/or diastolic blood pressure > 100 mmHg.
- Having evidence related to renal dysfunction:
- Proteinuria > 300 mg/day
- Having evidence of ketoacidosis at the time of selection.
- Having evidence of ongoing or frequent hypoglycemia.
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 |
|---|---|---|
| MSC and PRPMSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease. | Biological | MSC and PRP |
Primary outcome
Fasting blood glucose
Time frame: every month in the course of 6 months
Assess the changes in fasting blood glucose level after transplantation
Hemoglobin A1c (HbA1c) level
Time frame: 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
Evaluate the safety of therapy by number record of adverse events (AEs)
3 secondary outcomes
Insulin dose
Time frame: during the course of 6 months
C-peptide
Time frame: every month in the course of 6 months
Blood insulin level
Time frame: every month in the course of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Individual participant dataSharing planned: Yes
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Stem Cell Unit, Van Hanh General Hospital contact
Phuong Le, MSc-MD principal investigator
Stem Cell Unit, Van Hanh General Hospital
Ngoc Phan, MSc principal investigator
Stem Cell Institute, University of Science Ho Chi Minh City
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 MSC and PRP in people with Type 1 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 7 inclusion and 18 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 4 Apr 2018. 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 Le, MSc-MD ((+84)902742732, drbphuong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: every month in the course of 6 months). The study lists 3 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 4 Apr 2018.