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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Mesenchymal stem cell therapy for diabetes: clinical evidence, emerging strategies, and future perspectives
Han-Ying Jhuang1, Jo-Yu Lee2, Li-Tzu Wang1
1School of Medical Laboratory Science and Biotechnology, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan; Ph.D. Program in Medical Biotechnology, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.
Abstract:
Diabetes mellitus (DM) is a multifactorial metabolic disorder in which chronic hyperglycemia arises alongside adipose-tissue dysfunction, ectopic lipid accumulation, endothelial injury, and progressive multiorgan damage. These processes form an interconnected network, and because lowering glucose or blocking any single pathway leaves the other nodes active, the disease continues to advance even when glycemic targets are met. Therapies that act on several nodes at once are therefore conceptually attractive. Mesenchymal stem cell (MSC) therapy fits this requirement, engaging the immune, vascular, and metabolic arms of the disease at the same time through a shared paracrine program. Here, we analyze 107 registered interventional trials, drawn from 124 screened records, that evaluate MSC-based therapies across type 1 diabetes, type 2 diabetes, and a range of diabetic complications. Autologous bone marrow-derived MSCs (BMMSCs) and adipose-derived MSCs (AdMSCs) featured in the earliest trials, and registration has since shifted toward standardized allogeneic umbilical cord-derived MSCs (UCMSCs) and cell-free derivatives. The strongest and most consistent benefits appear in ischemic and wound-healing complications, particularly diabetic foot ulcers, whereas metabolic outcomes remain variable. Together, current early-phase evidence supports MSC therapy as a safe and potentially disease-modifying adjunct, although larger randomized trials with harmonized endpoints are needed to confirm efficacy.
Insights
Mesenchymal stem cell (MSC) therapy shows promise for diabetes complications, particularly in wound healing. While safe and potentially disease-modifying, further large-scale trials are needed to confirm its metabolic benefits.
Area of Science:
- Endocrinology and Metabolic Diseases
- Regenerative Medicine
- Immunology
Background:
- Diabetes mellitus (DM) involves complex hyperglycemia, adipose dysfunction, and multiorgan damage.
- Current therapies targeting single pathways are insufficient as DM progresses.
- Multimodal therapies acting on interconnected disease nodes are conceptually attractive.
Purpose of the Study:
- To analyze registered interventional trials evaluating mesenchymal stem cell (MSC) therapies for diabetes and its complications.
- To assess the evolution of MSC sources and therapeutic approaches in diabetes research.
- To evaluate the efficacy and safety of MSC-based treatments across different diabetic conditions.
Main Methods:
- Systematic review and analysis of 107 registered interventional trials from 124 screened records.
- Categorization of trials based on diabetes type (type 1, type 2) and complications.
- Examination of MSC sources (BMMSC, AdMSC, UCMSC) and cell-free derivatives.
Main Results:
- MSC therapy has been evaluated across type 1 diabetes, type 2 diabetes, and various diabetic complications.
- Early trials utilized autologous BMMSCs and AdMSCs; later trials shifted to allogeneic UCMSCs and cell-free derivatives.
- Most consistent benefits observed in ischemic and wound-healing complications (e.g., diabetic foot ulcers); metabolic outcomes were variable.
Conclusions:
- MSC therapy is a safe adjunct for diabetes, showing potential for disease modification, especially in wound healing.
- Evidence suggests MSCs engage immune, vascular, and metabolic pathways simultaneously.
- Larger, randomized trials with standardized endpoints are necessary to confirm MSC therapy's efficacy for metabolic control in diabetes.
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