Type 1 Diabetes Mellitus
Conditions
Interventions
Control:Placebo iv.
Treatment:GMSC iv.
Sponsors
the Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-60 years old male and female; (2) signing an informed consent form; (3) procedures in which the spirit is normal and can comply with the test protocol; (4) Comply with WHO 1999 diagnostic criteria for type 1 diabetes (T1DM); (5) The course of T1DM is = 2 years when enrolled; (6) Baseline C-peptide level = 0.3 ng/mL; (7) Glycated hemoglobin (HbA1c) = 7.0% when enrolled; (8) Women of childbearing age have no birth plan within 1 year.
Exclusion criteria
Exclusion criteria: (1) Body mass index BMI > 30 kg/m2; (2) insulin requirement > 100 U / day; (3) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) is 2.5 times higher than the upper limit of normal and / or serum creatinine (Cr) = 133umol/l (1.5mg / dl); (4) severe liver and kidney dysfunction, accompanied by proliferative diabetic retinopathy or macular edema; (5) had undergone coronary angioplasty, coronary stenting, coronary artery bypass surgery, myocardial infarction, unstable angina, clinically significant electrocardiographic abnormalities, cerebrovascular accidents or transient cerebral ischemia attack; (6) acute and chronic pancreatitis, active infections, including hepatitis C, HIV, or tuberculosis as determined by skin positive tests or clinical manifestations, or suspected tuberculosis treatment; (7) need long-term use of systemic steroid hormone therapy, patients with bleeding disorders: such as hemophilia, patients with primary thrombocytopenic purpura; (8) Patients with malignant tumors and mental illnesses who are allergic to MSC and preservation solution; (9) pregnant women, lactating women; (10) Other patients with severe concomitant diseases, which the investigators believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IVGTT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycometabolism index;Liver and kidney function index;Oxidative strss markers;Exogenous Insulin Demanded Quantity Change;Proinisulin Content;Urine albumer excretion rate;Immunological indicators;T-cell activity measure-de-E-receptor method;Inflammatory Factor Detection;Hypersensitive C-reactive Protein Levels; | — |
Countries
China
Contacts
Public ContactSong Guo Zheng
the Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed