Clonal fetal mesenchymal stem cell (cfMSC) therapy for type 2 diabetes
Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus
This will try an intravenous infusion of clonal fetal mesenchymal stem cells (cfMSCs) to see if they improve insulin production and blood sugar control in adults with long-standing, poorly controlled type 2 diabetes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07495956 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial delivers intravenous infusions of cfMSCs to adults with type 2 diabetes and persistent hyperglycemia despite standard treatment. Eligible participants have diabetes for >3 years, HbA1c ≥7.5% for at least 3 months, and measurable residual C-peptide (0.3–1.5 ng/mL). The study will monitor safety, tolerability, measures of islet function, glycemic control, and insulin requirements over follow-up. Treatment is administered at a single center with serial laboratory and clinical assessments to track adverse events and efficacy signals.
Who should consider this trial
Good fit: Adults aged 18–75 with type 2 diabetes for more than 3 years, poor glucose control on conventional therapy (HbA1c ≥7.5%), BMI 18.5–35 kg/m², residual fasting C‑peptide 0.3–1.5 ng/mL, and adequate organ function are ideal candidates.
Not a fit: Patients with minimal or no residual beta‑cell function (fasting C‑peptide <0.3 ng/mL), uncontrolled major organ disease, or other exclusionary conditions are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, cfMSC infusion could help repair islet function, improve insulin secretion and glycemic control, and reduce long-term complications of diabetes.
How similar studies have performed: Small early-phase trials of various mesenchymal stem cell approaches in diabetes have shown mixed safety results and modest glycemic improvements, while clonal fetal MSCs represent a newer, less-tested product.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, ph.D
- Email: c@szgimi.org
- Phone: +86 0755-86573763
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.