cfMSC Therapy for Diabetes

Summary

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.

Eligibility

Inclusion Criteria:

1. Ability to understand the study protocol and voluntarily sign the written informed consent form;
2. 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);
3. Age 18-75 years old, with a body mass index (BMI) of 18.5-35 kg/m²;
4. Fasting C-peptide level 0.3-1.5 ng/mL, indicating residual islet function;
5. Karnofsky performance score (KPS) ≥ 70, with good daily living ability;
6. Life expectancy \> 5 years;
7. 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);
8. No serious heart, brain, lung and other important organ diseases, and stable vital signs;
9. 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.

Exclusion Criteria:

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

Conditions2

Interventions1

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