Stem Cell Therapy Marginally Reduces HbA1c and Improves C-peptide in Type 1 Diabetes

Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by the destruction of pancreatic beta-cells, leading to absolute insulin deficiency. Despite intensive insulin therapy, many patients struggle with glycemic control, facing risks of hypoglycemia and long-term complications. Current treatments primarily manage symptoms, but stem cell therapy offers a promising avenue for disease modification, potentially restoring beta-cell function and reducing exogenous insulin dependence. This approach aims to address the underlying pathology rather than just managing its consequences.

Researchers conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating stem cell therapy in T1DM. They comprehensively searched PubMed, Embase, Web of Science, and CENTRAL for studies published until January 2025. The analysis included eight reports from seven RCTs with a total of 169 participants. The primary outcome assessed was glycated haemoglobin (HbA1c) levels. Secondary outcomes included fasting C-peptide levels, insulin dose reduction, insulin independence, and adverse events. The methodological quality and risk of bias for included studies were rigorously assessed using the Risk of Bias 2.0 tool.

The meta-analysis revealed that stem cell therapy was associated with a marginal, statistically significant reduction in HbA1c at 6 months, showing a mean difference (MD) of -0.57% (95% CI: -1.13 to -0.02). However, this effect was not sustained at 12 months, where the MD was -0.49% (95% CI: -0.98 to 0.00), indicating a loss of statistical significance. Fasting C-peptide levels, a marker of endogenous insulin production, demonstrated slight improvements at both time points: an MD of 0.03 ng/mL (95% CI: 0.03 to 0.03) at 6 months and 0.09 ng/mL (95% CI: 0.05 to 0.13) at 12 months. > None of the 169 participants across the included trials achieved insulin independence, and no serious adverse events were reported, suggesting a relatively safe profile but limited efficacy. The certainty of the evidence for all assessed outcomes was rated as "very low," highlighting significant methodological limitations and the need for more robust research.