A Systematic Review on Clinical Efficacy of Stem Cells Related Treatment Strategies for the Management of Diabetes Mellitus
Vasanthaprabha Rajasekar, Sri Hari Prasath GurumurthiAbstract
Background:
Diabetes mellitus (DM) is a prevalent chronic disease associated with high morbidity and mortality. Current therapeutic strategies remain limited in achieving sustained metabolic control and preventing long-term complications. Mesenchymal stem cell (MSC) based therapies have shown promising regenerative and immunomodulatory potential. Therefore, we conducted a systematic review to evaluate the clinical efficacy of stem cell-based therapies in the management of DM.
Materials and Methods:
A systematic search was conducted using electronic databases from January 2015 to December 2024. Eligible studies included randomized controlled trials (RCTs) and controlled experimental studies in humans or animal models that investigated a single stem cell-based intervention for type 1 DM (T1DM) or type 2 DM (T2DM). The process involved extracting data and evaluating study quality with the Cochrane Risk of Bias 2 tool; statistical analyses were conducted in RevMan 5.4.1.
Results:
Sixteen studies (seven human and nine animal) were included. Stem cell therapies consistently improved glycemic outcomes, including lower glycated haemoglobin, fasting, and postprandial glucose, with higher C-peptide and β-cell preservation. Clinical studies showed reduced insulin requirements and improved sensitivity, while preclinical models confirmed β-cell regeneration and immunomodulatory effects. Safety profiles were favorable, with no major adverse events reported.
Conclusion:
Stem cell-based therapies, especially MSCs, demonstrate significant potential as adjunctive treatments for T1DM and T2DM, improving glycemic control and reducing insulin dependence. While preclinical evidence is strong, clinical data remain limited. Larger, multicenter RCTs with extended follow-up are needed to confirm efficacy, standardize protocols, and ensure long-term safety.