type 2 diabetes mellitus
Conditions
Interventions
treatment group:conventional standard therapy and i.v. injection of autologous adipose-derived stem/stromal cells
Sponsors
Renmin Hospital, Hubei University of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes (T2DM) as defined by ADA (American Diabetes Association) on the Diagnosis and classification of Diabetes Mellitus. 2) Male and female patients age 18 to 70 years of age; and the ability to understand the treatment plan. 3) GAD antibody negative status. 4) Poor glycemic control with recent anti-diabetic therapies, including drugs and/or insulin injection for at least three months; no acute diabetic complications tendency. 5) Insulin and anti-diabetic medication doses should be stable over the 1-3 months prior to randomization. 6) 19 =7.0 mmol/L, and HbAc1>=7.0%. 8) Basal C-peptide 0.5-2.0 ng/mL. 9) Total insulin daily dose at baseline and at randomization <100 units/day. 10) Normal hepatic, cardiovascular, and renal function, no major organ dysfunction, stable enough for interventional treatment. 11) Patients willing to participate and follow up in this clinical trial; Understand and sign the consent form of this study. 12) Ability to tolerate liposuction. 13) There was no obvious abnormality in tumor marker detection, or patient was evaluated and has no risk of cancer.
Exclusion criteria
Exclusion criteria: 1. Pregnant or considering pregnancy in the next 6-month, lactating. 2. Positive tests for HIV, HCV, HBV and syphilis. 3. Uncontrollable or difficult to control cardiovascular and cerebrovascular, liver, kidney, lung, endocrine and other systematic diseases with a life expectancy of less than 1 year. 4. History of malignancy. 5. Acute or chronic infections; 6. Gestational diabetes. 7. Known autoimmune disease. 8. Subjects had alcoholism, drug abuse or mental illness within 3 years prior to this study. 9. Patient participating in another clinical study within 3 months of this study. 10. Serious bleeding tendency, poor coagulation function (PTA <35%). 11. The investigator realizes the patient is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse effects;Glycated hemoglobin, C-peptide; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycemia;Insulin requirement and oral hypoglycemic drugs;SF-36;Beta-cell function; | — |
Countries
China
Contacts
Public ContactBin Zhou
Hubei Provincial Renmin Hospital
Outcome results
None listed