cfMSC Therapy for Diabetes

Más betegség

• Type 1 diabetes mellitus or other special types of diabetes;
• Severe diabetes-related complications, such as end-stage renal disease, severe proliferative retinopathy, diabetic foot with ulcer and infection, etc.;
• A history of malignant tumors within 5 years, or current suspicious malignant tumor lesions;
• HIV, hepatitis B, hepatitis C and other infectious diseases with positive pathogen indicators;
• Active autoimmune diseases, or long-term use of glucocorticoids and immunosuppressants (except for small dose hormone replacement therapy);
• A history of severe allergic reactions, or allergy to the components of the study cell preparation;
• Mental diseases or poor compliance that cannot cooperate with the study; Other conditions that the investigator deems unsuitable for participating in the study.

Egyéb

• Pregnant or lactating women;
• Actively participating in other clinical research projects at the same time;

• Ability to understand the study protocol and voluntarily sign the written informed consent form;
• A clear diagnosis of type II diabetes mellitus for more than 3 years, with poor blood glucose control under conventional treatment (HbA1c ≥ 7.5% for 3 consecutive months);
• Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;
• Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;
• Karnofsky performance score (KPS) ≥ 70, with good daily living ability;
• Life expectancy > 5 years;
• Normal liver and kidney functions (bilirubin < 1.5×ULN, ALT/AST < 2.5×ULN, creatinine < 1.5×ULN); normal blood routine (absolute neutrophil count ≥ 1.8×10\^9/L, platelets ≥ 100×10\^9/L);
• No serious heart, brain, lung and other important organ diseases, and stable vital signs;
• Women of childbearing age have a negative pregnancy test within 7 days before enrollment, and all subjects of childbearing age agree to take effective contraceptive measures during the study and within 1 year after the end of the study; Willing to cooperate with the whole course of follow-up and complete all examination and observation indicators.