Safety and efficacy of human gingiva-derived mesenchymal stem cells in patients with type 1 diabetes: a double-blind, randomized, placebo-controlled, phase 1 trial.
Signal Transduct Target TherSep 30, 2026 (epub)
Qi Tang, Li Zhou, Liwen Fan et al.
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In 30 seconds
This phase 1 double-blind, randomized, placebo-controlled trial evaluated the safety and efficacy of human gingiva-derived mesenchymal stem cells (GMSCs) in 18 patients with type 1 diabetes mellitus (T1DM). Results showed that GMSC therapy improved residual β-cell function, as indicated by C-peptide levels, and reduced daily insulin requirements, with one patient achieving insulin withdrawal after the first treatment.
Key findings
- Patients receiving GMSCs showed improved C-peptide levels at week 12.
- There was a decrease in daily insulin requirements among GMSC-treated patients.
- One patient achieved insulin withdrawal after the first GMSC treatment.
- GMSC therapy did not increase the risk of adverse events, including hypoglycemia.
Why it matters
The findings suggest that GMSCs may offer a novel therapeutic approach for managing type 1 diabetes by potentially preserving β-cell function and reducing insulin dependency, which could improve patient outcomes.