Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
The purpose of this study is to assess the feasibility, safety and clinical efficacy of the novel clonal fetal mesenchymal stem cell (cfMSC) therapy in patients with type II diabetes mellitus.
• 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.