Mesenchymal Stem Cell Therapy for Type 1 Diabetes Mellitus Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03484741|
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 4, 2018
|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
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)email@example.com|
|Contact: Stem Cell Unit, Van Hanh General Hospitalfirstname.lastname@example.org|
|Van Hanh Geral Hospital||Recruiting|
|Ho Chi Minh City, Ho Chi Minh, Vietnam, 700000|
|Contact: Phuong Le, MSc-MD (+84)902742732 email@example.com|
|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|