Efficacy and Safety of Umbilical Cord MSCs for Type 2 Diabetes

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. 

Source:

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

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