umbilical cord mesenchymal stem cells and liraglutide in diabetes mellitus

Conditions: Type 2 Diabetes

Summary: umbilical cord mesenchymal stem cells (sc) transplantation was a novel therapy for diabetes mellitus, with less side effects and more advantages. clinical trials had verified that good metabolic control would be achieved when liraglutide (glp-1) was added to the conventional therapies. the investigators hypothesized that the combined therapy of umbilical cord mesenchymal stem cells transplantation and liraglutide in type 2 diabetes mellitus will aid the differentiation of stem cells into insulin-producing cells, improve the survival of differentiated cells, protect the residual beta-cells and improve insulin secreting function, so as to achieve a favorable glucose homeostasis.


Eligibility criteria:
inclusion criteria: * male and female patients age 35 to 65 years of age. * ability to provide written informed consent. * mentally stable and able to comply with the procedures of the study protocol. * clinical history compatible with type 2 diabetes (t2dm) as defined by ada(1997) on the diagnosis and classification of diabetes mellitus * basal c-peptide 0.5-2.0 ng/ml * hba1c ≥ 7.5 and ≤ 11% before standard medical therapy (smt). * patients must have been treated with smt for 1-4 months prior to matching. insulin dose and metformin doses should be stable over 1 month prior to matching. * hba1c ≥ 7.5 and ≤ 10% at time of matching. * total insulin daily dose (tdd) at time of matching should not exceed 1.0 units/day/kg * 18.5 kg/㎡≤bmi≤40.0kg/㎡ exclusion criteria: * abnormal liver function \>2.5 x uln * evidence of renal dysfunction:serum creatinine \> 1.5 mg/dl (males) and 1.3 mg/dl (females). * gastrointestinal operation history. * type 1 diabetes mellitus; dka; secondary diabetes. * uncontrolled blood pressure: sbp \>180 mmhg or dbp \>100 mmhg at the time of matching. * evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months. * presence of active proliferative diabetic retinopathy or macular edema. * any acute or chronic infectious condition that in the criteria of the investigator would be a risk for the patient. * for female participants: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study. for male participants: intent to procreate 3 months before or after the intervention or unwillingness to use effective measures of contraception. oral contraceptives, norplant?, depo-provera?, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. * active infection including hepatitis c, hiv, or tb as determined by a positive skin test or clinical presentation, or under treatment for suspected tb. * subjects that are being treated with any medication that could interfere with the outcome of the study such as: thiazolidinediones and other glucagon like peptide 1 (glp-1) analogues (exenatide, byetta), pramlintide (amylin), dipeptidyl-peptidase iv (dpp-iv) inhibitors (i.e. sitagliptin, januvia) * any known or suspected allergy to liraglutide or other relevant products. * evidence of thyroid adverse events (serum calcitonin increase, goiter, thyroid cancer, et al) or pancreatitis caused by other glp-1 analogues. * subjects with past history or family history of medullary thyroid carcinoma(mtc) or multiple endocrine neoplasia syndrome type 2(men2) .