Table 2.
Clinical use of human cultured epithelial substitutes (CESs).
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 41 | Autologous epidermal cells | Case Report | 2 (2/0) | 49.5 ± 16.2 (38–61) | None | Burns | 60 ± 28.3 (40–80) | – | 100 | 14–21 | 6 | Absence of stratum corneum during the first week, but 6 months after grafting, the epidermis could not be distinguished from native skin |
| 42 | Autologous keratinocytes | Case Report | 17 (11/6) | 31.8 ± 14.4 (2–56) | None | Burns | 56.1 ± 18.3 (31–85) | – | 31 | 18–22 | 1–1.5 | In some cases, 80% of epithelialized skin was achieved after 6 weeks. Hypertrophic scar formation was less than observed in comparable areas treated with meshed grafts |
| 43 | Autologous keratinocytes | Case Report | 26 | - | None | Burns | 50 (2–75) | – | 15 (0–98) | 7 | – | Limited success |
| 44 | Autologous keratinocytes | Case Report | 26 | 29.03 ± 18.7 (5–80) | None | Burns | 33 ± 16.7 (10–75) | 12.5 ± 6.4 (5–35) | 32.1 ± 15.3 (0–65) | 20–22 | 6 | Keratinocyte culture “take” was significantly lower than that split-thickness skin grafts |
| 4 | 3.7 ± 1.9 (1–5) | None | Giant congenital nevus | – | 55.9 ± 30.9 (30–100) | 56.2 ± 13.7 (40–70) | ||||||
| 45 | Autologous keratinocytes | Case Report | 16 | 29.7 (10–56) | None | Burns | 68.2 (42–85) | 15.9 (4–59) | 4.7 (0–18.6) | — | 4.3 (1.7–9.2) | No impact on the definitive closure of massive burn wounds |
| 46 | Autologous keratinocytes | Case Report | 5 (4/1) | 38.8 (20–60) | None | Burns | 59.6 (48–70) | — | 93.6 (87–100) | — | 48 | Only two patients required any additional grafts to cover open wounds that had originally been covered with CESs |
| 47 | Autologus epithelial cells | Case Report | 28 | 35.3 | None | Burns | 52.2 | 10.4 (2–35) | 26.9 | — | 60 | After 5 years of use, CES engraftment was unpredictable and inconsistent. Should be used only as biologic dressing and experimental adjunct to conventional burn wound coverage with split-thickness autograft |
| 48 | Autologous keratinocytes | Observational Study | 29 | 26 | None | Burns | 77 | — | 53 | 14–18 | 3 | Good cosmetic appearance when compared with meshed split-thickness skin grafting |
| 8 | 2.8 | None | Scald wounds | 23 | — | 73 | ||||||
| 49 | Autologous keratinocytes | Case Report | 7 (4/3) | 11.6 ± 10.7 (1.7–30) | None | Burns | 45.7 ± 19.88 (20–75) | — | 97.1 ± 7.5 | 14 | 2–20 | Epidermal regeneration evaluated 1 month after grafting was stable and complete. Epidermis appeared fully differentiated with a well-developed stratum granulosum |
| 50 | Autologous keratinocytes | Non-randomized trial | 8 | 10.5 ± 2 | Reconstructive procedures were required in the first 2 years for functional problems | Burns | 92.5 ± 1.9 | 44 ± 7 | 60 ± 8 | 21 | 24 | After follow-up scars had a significantly smoother surface and less pigmentation than traditional meshed autografts |
| 51 | Autologous keratinocytes | Non-randomized controlled trial | 7 | 32.1 ± 18 (9–65) | None | Burns | 68.7 ± 20.4 (51–95) | — | 65 ± 46.6 | 16–22 | 1 | An undulated dermo-epidermal junction was present underneath the grafted epithelia cultured on fibrin gel matrices |
| 52 | Autologous epidermal cell sheets | Non-randomized controlled trial | 14 | 40.8 ± 18.3 (3–61) | None | Palmoplantar wounds | — | 100 | 100 | 1 | 27.6 ± 10.5 (12–48) | Expression of keratin 9 was continuously observed after the transplantation |
| 53 | Autologous keratinocytes | Non-randomized controlled trial | 7 | 6.4 ± 1.4 | None | Burns Reconstructive releases | 75.9 ± 5.0 | — | 100 | — | 12 | Successful vascularization was observed in 45.7 ± 14.2% of the wounds, after 14 days |
| 54 | Autologous epidermal cells | Case Report | 2 (2/0) | 33 ± 1.4 (32–34) | None | Burns | 75 ± 14.1 (65–85) | — | 0 | 21–28 | 0.4 | These substitutes could be useful as temporary biological dressing as the take was so poor |
| 55 | Allogeneic keratinocytes | Retrospective Observational Study | 13 (7/6) | 62.2 ± 15.7 (34–84) | None | Chronic skin ulcers | — | 100 | 100 | — | 3.2 ± 2.3 (0.6–7) | There was an overall reduction of 91.5% of wound size in comparison with initial value |
| 56 (NCT00832156) | Autologous epidermal cells | Randomized Controlled Trial (parallel assignment) | 40 (25/15) | 50 ± 19 (20–85) | None | Burns | 24.2 ± 13 (6–51) | — | 90 ± 12.6 (6–51) | 13 | 12 | Epithelialization increased in the wounds after 5–7 days (71.2 ± 24.8%) |
aExpression of measures: mean ± standard deviation (range).