Stem Cell Therapy for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.

Detailed Description
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To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments. To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.

Official Title
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A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Biological: mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free will taking part in the study and ability to provide written informed consent; Type 2 diabetes mellitus (as guideline WHO, 1999); Age 18-75 years old，Male/Female; 19≤Body mass index (BMI)≤30㎏/㎡; Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％; Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance; Not pregnant or nursing; Negative pregnancy test; Fertile patients will use effective contraception. Exclusion Criteria: Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction); Active infection requiring treatment; Unexplained febrile illness; Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: mesenchymal stem cells|1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels; | Insulin resistance index indicated by ITT change compared with baseline. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and Postmeal blood glucose (PBG). C-peptide levels. Serum Insulin levels. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse event frequency and severity |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cells;, diabetes mellitus;, treatment.