Type 2 Diabetes Mellitus
Conditions
Keywords
stem cells;, diabetes mellitus;, treatment.
Brief summary
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
* 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.
Interventions
BIOLOGICALmesenchymal 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.
Sponsors
Cellonis Biotechnology Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Free will taking part in the study and ability to provide written informed consent; 2. Type 2 diabetes mellitus (as guideline WHO, 1999); 3. Age 18-75 years old，Male/Female; 4. 19≤Body mass index (BMI)≤30㎏/㎡; 5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％; 6. Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance; 7. Not pregnant or nursing; 8. Negative pregnancy test; 9. Fertile patients will use effective contraception.
Exclusion criteria
1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction); 2. Active infection requiring treatment; 3. Unexplained febrile illness; 4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels; | one year | 1. Insulin resistance index indicated by ITT change compared with baseline. 2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline. 3. Hemoglobin A1c. 4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG). 5. C-peptide levels. 6. Serum Insulin levels. |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse event frequency and severity | one year |
Countries
China
Outcome results
None listed