Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients
NCT ID: NCT03484741
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2017-04-01
2018-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
No
Sponsors
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University of Science Ho Chi Minh City
OTHER
Van Hanh General Hospital
OTHER
Responsible Party
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Principal Investigators
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Phuong Le, MSc-MD
Role: PRINCIPAL_INVESTIGATOR
Stem Cell Unit, Van Hanh General Hospital
Ngoc Phan, MSc
Role: PRINCIPAL_INVESTIGATOR
Stem Cell Institute, University of Science Ho Chi Minh City
Locations
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Van Hanh Geral Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DIME 1001
Identifier Type: OTHER
Identifier Source: secondary_id
DIME 1001
Identifier Type: -
Identifier Source: org_study_id
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