Table 3.
Clinical use of human cultured dermal substitutes (CDSs).
| Reference | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 60 | Allogeneic fibroblasts | Case Report | 5 (4/1) | 59.5 ± 19.5 (39–81) | In one patient, infection after 14 days was observed but resolved | Burns | – | 100 | 87.8 ± 9.6 (75–98) | 0 (TESSs were cryopreserved previously) | 10–14 | Failed to take permanently on the wound surface, but was able to produce cell growth factors which improved wound healing |
| 1 (0/1) | 88 | None | Necrotizing fasciitis | – | 100 | 88 | ||||||
| 61 | Allogeneic fibroblasts | Case Report | 3 (2/1) | 58.6 ± 12.3 | None | Skin ulcers prior to autologous skin grafting | – | 100 | 26.8 | 0 (TESSs were cryopreserved previously) | 6 | A greater amount of healthy granulation tissue was produced and suitable for autologous skin grafting |
| 62 | Allogeneic fibroblasts | Case Report | 13 (3/10) | 65 ± 9.5 (48–79) | One case presented local infection | Chronic and consecutive leg ulcers | – | 100 | 81.3 ± 9.65 (61–96) | 0 (TESSs were cryopreserved previously) | 2 ± 1.2 (0.75–4.75) | Effective not only for producing tissue granulation and epithelialization, but also for removing necrotic tissue |
| 63 | Allogeneic cryopreserved or fresh fibroblasts | Case Report | 7 (5/2) | 40.4 ± 16.6 | None | Surgical wounds | – | 100 | 100 |
0 (for TESSs previously cryopreserved) 7 (considering only time of culture of the fresh TESSs) |
0.27 | Cryopreserved TESSs were capable of releasing sufficient amounts of several cytokines and of promoting re-epithelialization to a degree comparable to fresh TESSs |
| 64 | Allogeneic fibroblasts | Case Report | 5 (0/5) | 62.6 ± 24.1 (37–89) | None | Skin ulcers | – | 100 | 66.7 | 0 (TESSs were cryopreserved previously) | 2 | Capable of promoting wound healing in intractable skin ulcers that failed to improve despite daily treatment with bFGF for more than 2 months |
| 65 | Allogeneic fibroblasts | Case Report | 8 (3/5) | 53.6 ± 14.1 (33–70) | One case presented local infection | Intractable skin ulcers | – | 100 | 78.4 ± 20.5 (36–100) | 0 (TESSs were cryopreserved previously) | 1 ± 0.3 | Healthy granulation tissue and epithelization developed rapidly in many cases |
| 66 | Autologous fibroblasts | Randomized, Controlled, Multicenter Clinical Trial | 31 (21/10) | 61.2 ± 11.4 | None | Diabetic ulcers | – | 100 | 84 | 21–28 | 12 | Time required for complete healing were lower in the TESS group than control group |
| 67 | Autologous fibroblasts | Prospective, Open‐Labeled Clinical Trial | 5 (5/0) | 60.6 ± 11.1 (47–73) | 30 adverse events, two directly related to the treatment but resolved | Diabetic ulcers | – | 100 | 94 ± 8.9 | >10 | 3 | Side effects were not serious, and three patients were completely healed within 12 weeks after application |
| 55 | Allogeneic fibroblasts | Retrospective Observational Study | 17 (11/6) | 63.3 ± 14.2 (42–91) | None | Chronic skin ulcers | – | 100 | 73.0 | – | 3.2 ± 2.3 (0.6–7) | There was an overall reduction of 73% in comparison with the initial wound size |
| 68 | Allogeneic fetal fibroblasts | Randomized, Double-Blind, Phase I Clinical Trial | 10 (9/1) | 29.5 ± 11 (13–46) | None | Surgical wounds | – | 100 | 94 | 7 (considering only time of culture of the TESSs) | 0.5 | Re-epithelialization was faster than in control groups |
aExpression of measures: mean ± standard deviation (range).