Clinical Trials in China / NCT07495956
Starting soon
Phase 1/2
cfMSC Therapy for Diabetes
NCT07495956 · tracked via the Priya Life Science China tracker
Condition(s) studied
Type II Diabetes Mellitus
Investigational drug(s) / intervention(s)
cfMSC therapy for diabetes
cfMSC therapy for diabetes: Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus
Study 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.
Primary outcome measure(s)
- Number of patients with adverse events. — 24 weeks
Determine the safety and tolerability of clonal fetal mesenchymal stem cell (cfMSC) therapy with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shenzhen Geno-immune Medical Institute | Shenzhen | Guangdong |
More Shenzhen Geno-Immune Medical Institute trials in China
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Starting soon
Lentiviral FVIII Gene Therapy
Starting soon
Multi-CAR-T Cells Targeting B Cell Lymphomas
Starting soon
PSMA-specific CAR-T Cell Therapy
Starting soon
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07495956 on ClinicalTrials.gov ↗ ← All trials in China