Cell Therapy in Diabetic Foot Ulcer

Diabetic foot ulcers (DFUs) present a significant challenge in healthcare due to their chronic nature and the complex disruptions they cause in the wound healing process. DFUs commonly result from an impaired healing cascade, affecting critical phases such as hemostasis/inflammation, reepithelialization, and tissue remodeling. These non-healing wounds not only diminish patients' quality of life but also place a substantial burden on healthcare systems worldwide. In recent years, stem cell therapy has emerged as a promising frontier in the treatment of chronic wounds, including DFUs, leveraging the immunomodulatory and regenerative capacities of stem cells and their derivatives. In this context, we conducted a Phase I clinical study to evaluate the safety and preliminary efficacy of placenta-derived stromal cells, embedded within an alginate hydrogel, for DFU treatment. Alginate hydrogel was selected as the cell carrier due to its excellent biocompatibility, which supports cell viability, proliferation, and differentiation. These placenta-derived stromal cells, known as DestroCell, have shown the potential to modulate inflammation, promote angiogenesis, and support tissue repair. Our trial enrolled seven DFU patients, divided into a treatment group receiving stromal cell-loaded alginate hydrogel and a control group receiving alginate alone. The results revealed that after three months, patients in the treatment group experienced an ۸۰% reduction in wound size, with most wounds progressing to the granulation or epithelialization phase, highlighting the effectiveness of cell therapy in advancing wound repair. By contrast, the control group saw a ۵۰% reduction in wound size, with some wounds remaining in the pre-granulation stage, indicating a higher likelihood of recurrence. Histopathological analyses demonstrated that the cell-based treatment was well-tolerated, with no signs of severe inflammation or adverse tissue responses, and the healing process was marked by the formation of collagen—a key factor in effective wound repair. This study underscores the promise of cell therapy in addressing the challenges associated with DFUs and highlights the potential of placenta-derived stromal cells within a supportive hydrogel matrix to promote meaningful clinical improvements. While these early results are promising, further investigations with larger sample sizes are necessary to confirm the full therapeutic potential of this approach and establish cell therapy as a standard treatment for DFUs.

کلیدواژه ها:

Diabetic foot ulcers ، stem cell therapy ، placenta-derived stromal cells ، alginate hydrogel ، wound healing