NCT07495956

cfMSC Therapy for Diabetes

Clonal Fetal Mesenchymal Stem Cell (cfMSC) Therapy for Type II Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Type II diabetes mellitus is a chronic metabolic disease with progressive islet β-cell dysfunction and insulin resistance as the core pathogenesis, leading to persistent hyperglycemia and a series of microvascular and macrovascular complications. Conventional treatments including lifestyle intervention, oral hypoglycemic agents and insulin injection can only control blood glucose levels, but cannot reverse the loss and dysfunction of islet β-cells, the root cause of the disease. At present, the clinical treatment of diabetes is mainly based on lifestyle intervention, oral hypoglycemic drugs and insulin injection, which can only control blood glucose and cannot fundamentally repair the damaged islet function and reverse the disease process. Mesenchymal stem cells have the characteristics of multi-directional differentiation potential, immune modulation, anti-inflammatory, allogeneic tolerance and paracrine effects. MSCs could have diverse sources. The fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential, high purity and can generate rich levels of various growth factors, and can achieve high quality consistency. The cfMSCs may modulate islet-like cells' differentiation, repair the damaged islet tissue, improve insulin resistance, and regulate the abnormal immune response of the body, which is a potential new strategy for the treatment of diabetes. This study aims to adopt intravenous infusion of cfMSCs to treat patients with type II diabetes who have poor curative effect from the conventional treatment. The goal is to evaluate the safety, feasibility and preliminary clinical efficacy of this novel therapy, and provide important clinical evidence for the clinical transformation and application of cfMSC therapy for diabetes, so as to bring new treatment options for diabetic patients.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	cfMSC therapy for diabetes	Clonal fetal mesenchymal stem cells (cfMSCs) therapy for type II diabetes mellitus

Timeline

• Start date: 2026-03-16
• Primary completion: 2029-03-31
• Completion: 2030-04-30
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China