Type 1 Diabetes Mellitus
Conditions
Keywords
stem cells;, diabetes mellitus;, treatment.
Brief summary
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
Detailed description
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
Interventions
BIOLOGICALautologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously.
Sponsors
Cellonis Biotechnology Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Free will taking part in the study and ability to provide written informed consent. 2. Confirmed diagnosis of type I diabetes for at least 2 years 3. Insulin-dependent. 4. Age 18-50 years, Male/Female. 5. FBG≥7.0 mmol/L, and HbAc1≥7％. 6. Not pregnant or nursing. 7. Negative pregnancy test. 8. Fertile patients will use effective contraception.
Exclusion criteria
1. Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure. 2. Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction). 3. Active infection requiring treatment. 4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. | 1 year | Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels. |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse event frequency and severity | 1 year |
Countries
China
Outcome results
None listed