Type 2 diabetes mellitus (T2DM) is a heterogeneous syndrome that is characterized by a progressive deterioration in glycemic control caused by decreased insulin sensitivity and diminished insulin secretion, which has become a serious threat to human health worldwide due to its high prevalence and severe morbidity.
Diet, physical exercise, and glucose-lowering medications have been shown to temporarily improve hyperglycemia but cannot inhibit the pathogenesis or reduce the morbidity of T2DM.
Mesenchymal stem cells (MSCs) are a type of adult stem cells with profound anti-inflammatory and immunomodulatory capacities by secreting a variety of cytokines and immunosuppressive molecules. They have been successfully applied in the treatment of different types of autoimmune diseases, and other medical conditions such as stroke, and myocardial infarction.
A phase II trial was performed by researchers in China, to evaluate the safety and efficacy of umbilical cord-derived MSCs (UC-MSCs) in Chinese adults with T2DM. The study appears in the journal Stem Cell Research & Therapy.
A Good Therapeutic Alternative
The study included a total of 91 patients that were randomly assigned to either receive an intravenous (IV) infusion of UC-MSCs or a placebo 3 times with 4-week intervals. The team followed up the participants for 48 weeks.
The participants received 1 Million MSCs per kg for each infusion. The primary endpoint was the percentage of patients with HbA1c levels of < 7.0% and daily insulin reduction of ≥ 50% from baseline to 48 weeks. The secondary endpoints were changes in insulin requirement and HbA1c levels.
After 48 weeks, 20% of the patients in the treatment group reach the goal. The percentage of insulin reduction of the UC-MSCs group was significantly higher than that of the placebo group (27.78% versus 15.62%, p < 0.05).
The study showed that UC-MSCs transplantation could be a good alternative therapeutic option for patients with T2DM, to improve their metabolic control and reduce insulin requirements.
Zang, L., Li, Y., Hao, H. et al. Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial. Stem Cell Res Ther 13, 180 (2022). https://doi.org/10.1186/s13287-022-02848-6