Clinical trial
Outcomes of Expanded Autologous Bone Marrow-derived Mesenchymal Stem Cells Therapy in Type 2 Diabetes
Name
VinmecRISCGT70
Description
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mesenchymal stem cells transplantation in the treatment of type 2 diabetes mellitus
Trial arms
Trial start
2017-11-01
Estimated PCD
2019-08-01
Trial end
2019-08-01
Status
Completed
Phase
Early phase I
Treatment
Expanded autologous bone marrow-derived mesenchymal stem cell
Collect bone marrow from lilac crest using local anaesthetic and syringe collection. Mesenchymal stem cell will be isolated, expanded and characterized in vitro under the GMP- grade procedure
Arms:
Stem cell transplantation
Size
30
Primary endpoint
Insulin dose
up to the 12-month period following treatment
Adverse events
up to the 12-month period following treatment
Eligibility criteria
Inclusion Criteria:
* Males and females
* Age from 18 years and above.
* Hemoglobin A1c (HbA1c) is ranged from 7.5% to 9% at baseline.
* Type 2 diabetes duration 5 years or more.
* Before the screening, joint or combined with insulin, oral medications to treat more than 3 months.
* Who signed the informed consent form.
Exclusion Criteria:
* Type 1 diabetes.
* Chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, etc.
* According to the medical doctor's judgement, may endanger the safety of the subjects
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-06-04
1 organization
1 product
1 indication
Indication
Type 2 Diabetes Mellitus