Stem Cells From Human Exfoliated Teeth in Treatment of Diabetic Patients With Significantly Reduced Islet Function
ClinicalTrials.gov Identifier: NCT03912480
Study information
Sponsor: Second Military Medical University, China
Study Phase: Phase I/II
Study Type: Interventional Clinical Trial
Estimated Enrollment: 24 participants
Study Population: Adults with type 2 diabetes mellitus and significantly reduced pancreatic islet function.
BACKGROUND:Type 2 diabetes is characterized by insulin resistance and progressive loss of pancreatic β-cell function, making long-term blood glucose control increasingly difficult. Although current medications can improve glycemic control, they do not restore damaged pancreatic tissue. Dental pulp stem cells (DPSCs) possess immunomodulatory and regenerative properties that may improve islet function, reduce insulin requirements, and promote metabolic recovery.
METHODS:This Phase I/II clinical trial evaluates the safety and therapeutic efficacy of intravenous dental pulp stem cell (DPSC) infusions in patients with type 2 diabetes and markedly reduced islet function. Participants receive multiple DPSC infusions and undergo follow-up assessments of fasting blood glucose, glycated hemoglobin (HbA1c), pancreatic islet function, insulin requirements, lipid metabolism, and treatment safety over a 12-month period.
RESULTS:The study has been completed, and the associated clinical findings demonstrated that DPSC therapy improved glycemic control, reduced insulin requirements, and enhanced pancreatic islet function in many participants. Patients with lower baseline triglyceride levels and better preserved β-cell function experienced the greatest therapeutic benefit, while treatment was well tolerated with no serious treatment-related adverse events reported.
CONCLUSIONS:This clinical trial demonstrated that dental pulp stem cells may represent a safe and promising regenerative therapy for patients with type 2 diabetes and significantly reduced islet function. The findings support continued clinical development of DPSC-based therapies aimed at restoring pancreatic function and improving long-term diabetes management.
ClinicalTrials.gov Identifier: NCT03912480
Sponsor: Second Military Medical University, China