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Updated: Jun 3, 2026

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Clinical Outcomes and Safety of Stem Cell Therapy for Diabetic Foot Ulcers: A Cross-Sectional Analysis of Overlapping
Ying Du1, Zhendong Xu2, Tianlin Wen1
1Department of Orthopedics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.
Purpose:
The care of diabetic foot ulcers (DFU) continues to be a notable clinical challenge. The efficacy and safety of stem cell therapies versus conventional treatments for DFU are debated. Cross-sectional analyses of meta-analyses enable structured comparisons of overlapping reviews, facilitate the identification of inconsistencies, and support evidence-based decision-making when conclusions differ. This study aimed to conduct a cross-sectional analysis of existing meta-analyses comparing stem cell and conventional treatments for DFU outcomes to identify the highest-quality available evidence and clarify areas of consistency and discrepancy.
Methods:
We systematically searched for meta-analyses that investigated stem cell therapies versus conventional treatments for DFU. The complete electronic search strategies for all databases are provided in accordance with PRISMA 2020 recommendations. Methodological quality was assessed using the Oxford Levels of Evidence and original AMSTAR instrument. Data abstraction and quality evaluation were performed independently, and the Jadad decision algorithm was applied to determine the meta-analysis providing the most methodologically robust evidence.
Results:
Nine meta-analyses were included in this study. Five were categorized as Level II evidence, while the remaining four were classified as Level III evidence. The AMSTAR scores ranged from 7 to 10 (median 9). The Jadad algorithm identified the most robust meta-analysis consistently showing improved ulcer healing rates (P < 0.0001), greater pain-free walking distance (P < 0.00001), lower amputation rates (P < 0.0001) compared with conventional treatments. Furthermore, the incidence of adverse events in the stem cell groups was lower compared to conventional treatments (P < 0.001).
Conclusion:
The study indicated that stem cell therapy appeared to be a promising therapeutic option for improving clinical outcomes. However, conclusions should be interpreted with caution due to overlapping primary studies, heterogeneity, and the secondary nature of this cross-sectional evaluation. Moreover, no clear evidence of increased serious adverse events was identified in the highest-quality meta-analysis.
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