NCT06727721
Safety and Efficacy of OCN19-overexpressed Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Refractory Type 2 Diabetes Mellitus
Recruiting · Phase 2 · Lu jin ，MD · registry updated 2024-12-17
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Umbilical cord mesenchymal stem cell injection expressing OCN19, while playing the role of MSCs, can directly stimulate the expression of insulin gene and the division and proliferation of islet beta cells, which is expected to further enhance the therapeutic effect of stem cells. In non-clinical studies, it was found that MSCs expressing OCN19 had better hypoglycemic effect than MSCs
Inclusion
- Accoding to WHO diagnostic standards, patients with type 2 diabetes (fasting blood glucose ≥ 7.0 mmol/L), 30-75 years old, regardless of gender;
- Able to clearly understand the purpose of clinical trials and comply with trial requirements, willing to participate in this study, and sign an informed consent form;
- kg/m2 ≤ Body Mass Index (BMI) ≤ 30 kg/m2;
- % ≤ glycated hemoglobin ≤ 10%;
- Insulin should be subcutaneously injected for more than six months, and insulin and/or other oral hypoglycemic drugs (limited to metformin only) should be used α The dosage of glycosidase inhibitors remained stable for the first 3 months before randomization;
- During the study period, all males and females with reproductive potential were willing to accept the use of efficient contraceptive methods.
Exclusion
- Type diabetes, pregnancy diabetes or other special type diabetes patients;
- Patients with severe allergic constitution or allergic to any ingredients used in cell culture;
- Patients who have used drugs that affect glucose metabolism within the past month, such as glucocorticoids, thiazide diuretics, oral contraceptives, tricyclic antidepressants, etc;
- Screening the patients with acute complications such as diabetes ketoacidosis and non ketotic hyperosmolar syndrome in recent 6 months;
- Serious cardiovascular and cerebrovascular events such as NYHA grade III or IV heart failure, myocardial infarction, cerebral infarction, and cerebral hemorrhage occurred within the past 6 months;
- Patients with abnormal blood routine (including white blood cell or neutrophil count below the lower limit of normal, abnormal platelet count, and hemorrhagic disease);