Regenerative Approaches to Diabetes: A Comprehensive Review of Stem Cell Therapeutics
DOI: https://doi.org/10.5281/zenodo.21680635
Dr. Kavita Sharma, Dr. Richa Ghai, Dr. Niranjan Rathee
Views: 51 | Downloads: 33
Abstract:
Background: Stem-cell therapies are considered a novel approach for diabetes therapy as a regeneration tool for β-cell function or immune regulation. Although several cell types have been taken through to clinical trials, the evidence base is still diverse. Several cell types have been investigated for clinical trials, but there is currently only a scattered evidence. Methods: Structured literature search was done in PubMed, Embase and ClinicalTrials.gov databases reporting a research study published from January 2000 through June 2025, followed by reference screening. Clinical trials, pilot studies, and case series of stem-cell therapies for type 1 or type 2 diabetes reporting data on glycemic control, β-cell function, insulin requirement and safety were all included. One thousand and twenty (1200) records were identified and 55 were included. Information was collected about design, patient population, cell source, delivery method, efficacy outcomes and adverse events. Heterogeneity of study designs and endpoints led to a descriptive synthesis of findings. Results: Modest improvements in HbA1c and C-peptide were seen across the board, and insulin requirements were reduced in subgroups of patients with mesenchymal stem cells (MSCs). The use of hematopoietic stem cell (HSC) transplantation had potential remission-inducing efficacy in newly diagnosed type 1 diabetes, but with conditioning regimen-related risks. Long-term durability has not been demonstrated from early-phase studies of pluripotent stem cell–derived islets (from ESCs and iPSCs) that have shown encouraging signals of β-cell replacement. Adverse events were generally mild across modalities, the most common being infusion reactions, and/or transient metabolic changes, with serious events mostly due to immunosuppression or myeloablation. To date, there are no human studies that confirm the absence of malignant transformation, but follow-up is limited. Conclusions: Stem-cell therapies for diabetes have shown efficacy and show reasonable short-term safety, but are still in the experimental stage. The evidence available is limited by small sample size, methodological variation and short follow-up periods. Before routine clinical use can be recommended, larger multi-center randomized trials with the same endpoints, GMP-quality manufacturing, and long-term surveillance are needed.