Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients
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|ClinicalTrials.gov Identifier: NCT03484741|
Recruitment Status : Unknown
Verified April 2018 by Van Hanh General Hospital.
Recruitment status was: Recruiting
First Posted : April 2, 2018
Last Update Posted : April 4, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: MSC and PRP||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Preliminary Safety and Efficacy Evaluation of Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus (T1DM) Patients|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: MSC and PRP
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.
Biological: MSC and PRP
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.
- 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)
- Insulin dose [ Time Frame: during the course of 6 months ]Reduction of insulin dose after transplantation
- C-peptide [ Time Frame: every month in the course of 6 months ]Assess the improvement in C-peptide level after transplantation
- Blood insulin level [ Time Frame: every month in the course of 6 months ]Assess the changes in blood insulin level after transplantation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484741
|Contact: Phuong Le, MSc-MD||(+84)firstname.lastname@example.org|
|Contact: Stem Cell Unit, Van Hanh General Hospitalemail@example.com|
|Van Hanh Geral Hospital||Recruiting|
|Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000|
|Contact: Phuong Le, MSc-MD (+84)902742732 firstname.lastname@example.org|
|Principal Investigator:||Phuong Le, MSc-MD||Stem Cell Unit, Van Hanh General Hospital|
|Principal Investigator:||Ngoc Phan, MSc||Stem Cell Institute, University of Science Ho Chi Minh City|
|Responsible Party:||Van Hanh General Hospital|
|Other Study ID Numbers:||
DIME 1001 ( Other Identifier: Ministry of Health, Viet Nam )
|First Posted:||April 2, 2018 Key Record Dates|
|Last Update Posted:||April 4, 2018|
|Last Verified:||April 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Clinical Study Report (CSR)
|Time Frame:||6 months after publication|
|Access Criteria:||Type 1 Diabetes Mellitus|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Endocrine System Diseases
Immune System Diseases