The Safety and Efficacy of Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes- A Literature Review

Abstract

Introduction: Type 2 diabetes (T2D) is the most common type of diabetes, affecting 6.28% of the population worldwide. Over the decades, multiple therapies and drugs have been developed to control T2D, but they are far from a long-term solution. Stem cells are promising as novel regenerative treatments, especially mesenchymal stem cells (MSCs), which are highly versatile in their regenerative and paracrine capabilities and characteristics. This makes them the most commonly used adult stem cells and ideal candidates to treat diabetes.

Objective: To assess the safety and efficacy of mesenchymal stem cells (MSCs) in treating Type 2 diabetes (T2D) in humans.

Methods: Mesenchymal stem cell-based treatments were studied in 262 patients. A total of 6 out of 58 trials fit our inclusion criteria in the last five years.

Results: The treatment of patients with MSCs reduced the dosage of anti-diabetic drugs analyzed over a follow-up period of 12 months. The effective therapy dosage ranged from 1×10⁶ cells/kg to 3.7×10⁶ cells/kg. After treatment, HbAc1 levels were reduced by an average of 32%, and the fasting blood glucose levels were reduced to an average of 45%. The C-peptide levels were decreased by an average of 38% in 2 trials and increased by 36% in 4 trials. No severe adverse events were noted in all trials.

Conclusion: This analysis concludes that MSC treatment of type 2 diabetes is safe and effective. A larger sample size is required, and the trials should also study the effect of differentiated MSCs as insulin-producing cells.

Keywords: diabetes; mesenchymal stem cells; regenerative medicine; stem cell.

Figure 1

Flow diagram - T2DM: T2DM is attributed to multiple risk factors, as mentioned above. These factors can cause beta-cell dysfunction over a period of time. Low capacity or dysfunction of the beta cells reduces insulin secretion by the pancreas, which in turn causes hyperglycemia. These risk factors can also lead to increased fatty acid production by the liver, which causes high amounts of glucose secretion to form in the liver. Increased glucose secretion reduces the function of insulin and leads to insulin resistance. Hyperglycaemia leads to low amounts of glucose absorbed by the muscles and causes an immune response. This damages the liver further and increases insulin resistance.

Figure 2

Prisma Diagram for study analysis. The diagram depicts the inclusion and exclusion criteria for the studies added to the article.

Figure 3

Insulin requirement before and after MSC treatment. The trials showcased different follow-up times. T1, T3, and T6 showed a decline in insulin requirement for a follow-up period of 3 and 6 months but a steady increase in need at the 12-month follow-up. T5 showed a 45% decrease in insulin requirement when followed up at the 6-month mark, but this study was not followed up further. T4 displayed a 22% lower insulin requirement during the 12-month follow-up period. Insulin requirement for T2 was 30% lower at the ten-month follow-up period, after which the study was not followed up.

Figure 4

C-peptide Levels after transplantation of MSCs. T1 and T4 noticed a reduction in c-peptide levels by 12% and 64%, respectively. T2, T3, and T5 noted an increase in the C-peptide levels by 62%, 40%, and 34%, respectively. An increase in T6 was noted after treatment by 10%.

Figure 5

HbAc1 levels before and after treatment with MSCs. There was a significant decrease in the HbAc1 levels in all trials. After follow up, the HbAc1 levels reduced to 1.2%, 32%,26%,7.1%, 31% and 6% for T1, T2, T3, T4, T5, and T6 respectively.