Table 5.
Clinical use of human mesenchymal stem cells in tissue-engineered skin substitutes (TESSs).
| References | Cells | Type of clinical study | n (male/ female) | Age (years)a | Treatment-related adverse events | Indication | Total body surface area (TBSA) affected (%)a | Affected area covered (%)a or Affected area covered (%TBSA)a | TESS successful engraftment (%)a or TESS successful engraftment (% TBSA)a | Period between skin biopsy and grafting (days)a | Follow-up (months)a | Outcomes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 172 | Autologous hBM-MSCs | Case Report | 1 | 77 | None | Diabetic wounds | – | 100 | 100 | 0, 7, and 17 | 1 | Wound showed a steady overall decrease in size and an increase in vascularity of the dermis and in the dermal thickness of the wound after 29 days |
| 173 | Autologous hBM-MSCs | Case Series | 20 (9/11) | 64.8 ± 20 (22–91) | None |
Severe burns (2) Decubitus ulcer (11) Skin ulcers (7) |
50 ± 14.1 (40–60) –Burns | – | 100 | Few weeks | >2 | High tissue regenerative ability was observed, the healing mechanism was activated, and therapeutic effects were independent of age or cause |
| 174 | Autologous hBM-MSCs | Case Report | 1 (1/0) | 19 | None | Burns—Scar excision wounds | >60 | – | 60 | – | 24 | Contraction of skin was significantly less at the hBMMSC transplantation site than at the control site |
| 175 | Autologous hAT-MSCs | Case Report | 2 (0/2) | 48.5 ± 9.2 (42–55) | None | Surgical wounds— Burns | – | 100 | 100 | 0 | 7–60 | This technique was not recommended routinely, but should be considered for burns patients with contractures affecting cosmetically or functionally challenging areas |
| 176(NCT02619877) | Allogeneic hAT-MSCs | Phase II Multicenter Randomized Clinical Trial (parallel assignment-single blind) |
22 (14/8) 17 (13/4)–Control Group |
59.9 ± 13.3 (26–80) 68.4 ± 9.9 (43–79) |
None | Chronic diabetic ulcers | – | 100 | 100 | 0 | 3 | Complete wound closure was achieved for 82% of patients in the treatment group and 53% in the control group at week 12 |
| 178 | Allogeneic hWJ-MSCs | Randomized Clinical Trial | 5 | (30–60) | None | Chronic diabetic wounds | – | 100 | 96.7 | – | 1 | After treatment, some patients reported even a decline in pain |
| 177 | Autologous hAT-MSCs | Prospective Clinical Analysis | 6 (3/3) | 66.3 ± 9.0 | None | Chronic diabetic ulcers | – | 100 | 74.5 ± 32.5 | 21 | 3 | There was granulation tissue formation starting from 7 days after topical application. After 90 days, a healed and re‐epithelialized tissue was observed |
aExpression of measures: mean ± standard deviation (range).