Mesenchymal stem cells (MSCs) may hold great promise for treating diabetic wounds. However, it is difficult for a clinician to use MSCs because they have not been commercialized. Meanwhile, a new commercial drug that contains adipose-derived stem cells (ASCs) has been developed. The purpose of this study was to examine the potential of allogeneic ASC sheets for treating diabetic foot ulcers. Fifty-nine patients with diabetic foot ulcers were randomized to either the ASC treatment group (n = 30) or a control group treated with polyurethane film (n = 29). Either an allogeneic ASC sheet or polyurethane film was applied on diabetic wounds weekly. These wounds were evaluated for a maximum of 12 weeks. Complete wound closure was achieved for 73% in the treatment group and 47% in the control group at week 8. Complete wound closure was achieved for 82% in the treatment group and 53% in the control group at week 12. The Kaplan-Meier median times to complete closure were 28.5 and 63.0 days for the treatment group and the control group, respectively. There were no serious adverse events related to allogeneic ASC treatment. Thus, allogeneic ASCs might be effective and safe to treat diabetic foot ulcers.
Bibliographical noteFunding Information:
Acknowledgments. The authors thank all patients and health care professionals who contributed to make the trial possible. In addition, the authors thank the investigators for their commitment, time, and effort. Funding and Duality of Interest. This study was supported by grants from Anterogen (Seoul, South Korea) and the Ministry of Health & Welfare, Republic of Korea (grant HI16C1037). This research also was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute. No other potential conflicts of interest relevant to this article were reported. Author Contributions. K.-C.M. had direct access to original data, interpreted the data, critically revised the draft of the manuscript, wrote the final version of the manuscript, and approved the final manuscript. H.-S.S. had direct access to original data; contributed to data recording; identified, treated, and monitored study participants; critically revised the draft of the manuscript; and approved the final manuscript. K.-B.K. had direct access to original data, contributed to data analyses and handling, critically revised the draft of the manuscript, and approved the final manuscript. S.-K.H. coordinated the work; had direct access to original data; contributed to data recording; interpreted the data; identified, treated, and monitored study participants; critically revised the draft of the manuscript; and wrote and approved the final version of the manuscript. K.-W.Y. and J.-W.L. identified, treated, and monitored study participants; had direct access to original data; contributed to data recording; critically revised the draft of the manuscript; and approved the final manuscript. M.-H.K. was a researcher and supervised laboratory analyses of this study. K.-C.M. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. Parts of this study were presented in abstract form at PRS Korea 2018: the 76th Congress of the Korean Society of Plastic and Reconstructive Surgeons and the 2nd Asian Forum for Fat & Stem Cells, Seoul, South Korea, 9–11 November 2018; the 6th World Congress for World Association for Plastic Surgeons of Chinese Descent, the 2018 Asian Pacific Plastic and Reconstructive Surgery Forum, and the 2018 Annual Meeting of Taiwan Society of Plastic Surgery, Taipei, Taiwan, 29 November to 1 December 2018; and the 8th Congress for the Korea Association of Stem Cell and Tissue Regeneration, Seoul, South Korea, 2 December 2018.
© 2019 by the American Diabetes Association.
All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism