Umbilical Cord-Derived Mesenchymal Stem Cells Infusion in Type 2 Diabetes Mellitus Patients: A Retrospective Cytopeutics' Registry Study.

Background: Type 2 diabetes mellitus (T2DM) is characterized by insulin resistance, leading to elevated blood glucose levels. Cellular therapies offer promise for improving hyperglycemia in T2DM. This retrospective study aimed to assess the clinical effectiveness of intravenous allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusion in T2DM patients through various clinical evaluations, focusing on systemic inflammation, metabolic dysfunction, and insulin resistance.

Methods: The data from a total of 218 T2DM patients who attended for follow-up after 6 months, and 83 patients after 12 months after receiving 50-100×10⁶ allogeneic UC-MSCs were analyzed. Blood and urine samples were collected at baseline and follow-up. Key evaluations included changes in anthropometry, diabetes indices, lipids, liver, renal, hormonal, and inflammatory markers.

Results: All patients demonstrated satisfactory outcomes, without adverse effects. Significant reductions in HbA1c levels were observed at 6-months (p<0.001) and 12-months (p=0.016). Insulin (p=0.048) and HOMA-IR (p=0.007) levels significantly reduced within 6-months, with same trend at 12-months. ALT and GGT levels significantly decreased (p<0.05), indicating a reduction in liver inflammation. hs-CRP level among patients with higher inflammation were also reduced at 6-months (p=0.073) and significantly at 12-months (p=0.016). Testosterone (p=0.050) and estradiol (p=0.043) levels increased in males and females, respectively, during 12-month follow-up. Additionally, estimated glomerular filtration rate (eGFR) and creatinine levels improved in stage 2 chronic kidney disease (CKD) at 6- and 12-month (p<0.05), indicating recovered renal function for those in early stage of CKD.

Conclusion: Allogeneic UC-MSCs infusion is safe for patients with T2DM and is associated with overall health outcomes, with sustained benefits up to 12 months. Notably, the treatment significantly improved metabolic indices including glycemic control, liver and renal profile and systemic subclinical inflammation. These findings provide a basis for further exploration of UC-MSCs in managing T2DM in proper randomized control trial, by addressing both metabolic dysregulation and inflammation.