The article presents the results of a Phase II randomized, placebo-controlled clinical trial conducted in China, aiming to evaluate the efficacy of intravenous infusion of Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) in adults with Type 2 Diabetes Mellitus (T2D).
1. Methodology
A total of 73 patients were assigned to receive UC-MSC or placebo infusions three times at 4-week intervals, with follow-up for 48 weeks.
2. Metrics
The primary endpoints included changes in Time in Range (TIR) — a metric reflecting the percentage of time glucose levels remain within the target range — and Glycated Hemoglobin (HbA1c).
3. Results
Both groups showed improvements from baseline, but the UC-MSC group demonstrated significantly greater increases in TIR and reductions in HbA1c at 9 and 48 weeks, indicating better glycemic control. More patients in the UC-MSC group achieved the glycemic target (TIR ≥ 70% and HbA1c < 7%) than in the placebo group.
Benefits of Mesenchymal Stem Cells (MSC) in Type 2 Diabetes
1. Significant Improvement in Glycemic Control
1.1 Increased Time in Range (TIR)
MSC therapy was associated with a greater duration of glucose levels within the healthy range, the primary benefit of the study. TIR is considered a superior metric for assessing daily glycemic variability.
1.2 Reduction of HbA1c
Patients treated with UC-MSCs achieved a more pronounced reduction in HbA1c, the standard long-term marker of glucose control.
2. Sustained Long-Term Impact
The beneficial effects on TIR and HbA1c persisted throughout the 48-week follow-up, suggesting a lasting therapeutic benefit.
3. Establishing an Effective Therapeutic Approach
The results highlight that intravenous administration of umbilical cord-derived MSCs is an effective approach to improve TIR, reduce glycemic variability, and potentially lower long-term complications associated with diabetes.
