Bioimpacts. 2022;12: 51-55.
doi: 10.34172/bi.2021.22167
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Original Research

Mesenchymal stromal cell therapy alone does not lead to complete restoration of skin parameters in diabetic foot patients within a 3-year follow-up period

Nadezhda V. Maksimova 1 ORCID logo, Anna V. Michenko 2, Olga A. Krasilnikova 3 ORCID logo, Ilya D. Klabukov 3* ORCID logo, Igor Yu. Gadaev 4 ORCID logo, Michael E. Krasheninnikov 5 ORCID logo, Pavel A. Belkov 6, Aleksey V. Lyundup 5 ORCID logo

1 Department of Endocrinology, Sechenov First Moscow State Medical University (Sechenov University), Russia
2 Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology, Moscow, Russia
3 Department of Regenerative Technologies and Biofabrication, National Medical Research Radiological Center, Obninsk, Russia
4 Chair of Hospital Therapy â„–1, Sechenov First Moscow State Medical University (Sechenov University), Russia
5 Research and Educational Resource Center for Cellular Technologies, Peoples’ Friendship University of Russia, Moscow, Russia
6 Company ANTA-Med, Moscow, Russia
*Corresponding Author: Corresponding author: Ilya D. Klabukov, Email: ilya.klabukov@gmail.com


Introduction: Mesenchymal stromal cells (MSCs) administration is an effective option for the treatment of diabetic foot ulcers (DFUs). However, to date, studies assessing long-term outcomes and evaluating skin parameters after cell-based therapy are lacking. We presented the clinical outcomes of 3 patients, treated for DFUs with the bone marrow MSCs 3 years earlier.
Methods: Ultrasound examination was used to compare collagen density and epidermal thickness in areas of healed ulcers in comparison with non-affected skin used as a control. Ultrasound and dermatoscopy were used to exclude neoplasm formation, to assess scar contracture and wound recurrence.
Results: In all patients, no ulcer recurrence was detected, which was lower than the expected 60% rate of re-ulceration in diabetic patients in a 3-year period (OD [odds ratio] = 0.095, P = 0.12). No neoplasm formation, no contracture of hypertrophic scar, and adjacent tissue were registered. Collagen ultrasound density was decreased by 57% (P = 0.053) and epidermal thickness was increased by 72% (P = 0.01) in the area of healed ulcers in all patients.
Conclusion: MSCs therapy alone did not result in the complete restoration of the skin parameters within a 3-year period. MSCs may represent important adjuvant to the therapy, however, other novel approaches are required to achieve better results.
Keywords: Cell therapy, Diabetic foot ulcer, Mesenchymal stem cells, Mesenchymal stromal cells, Regenerative medicine, Wound healing
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Submitted: 26 May 2020
Revision: 21 Jul 2020
Accepted: 29 Jul 2020
ePublished: 25 Sep 2021
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