Table 2.
Wound healing outcomes using allogeneic epidermal TESSs in clinical studies for EB
| EB subtype | References | Study type | Patients (N) | Type of TESS | Follow-up | Outcome |
|---|---|---|---|---|---|---|
| RDEB | [31] | Case report | 1 | Skin explants derived from full-thickness allografts cultured on plastic culture surface into stratified epithelia | 4 months | No sign of rejection, inflammation or any significant blistering at the allograft site; however, no further follow-up to assess long-term wound closure |
| [31] | Case report | 1 | Keratinocytes cultured on a feeder layer of murine fibroblasts into keratinocyte sheets | 4 months | All wounds epithelialised at 7 days with no renewed blistering; however, no further follow-up to assess long-term wound closure | |
| [31] | Prospective study | 6 | 2 weeks | 4 out of the 6 allograft sites healed faster than the controls over a short 2-week follow-up. However, no change in C7 levels were observed, suggesting that allogeneic keratinocytes were promoting proliferation and migration of resident C7-mutant keratinocytes at the wound edges via the release of cytokines and growth factors | ||
| [22] | Prospective study | 10 | 2 weeks | Slight analgesic effect, but no functional repair | ||
| [31] | Case report | 1 | Allogeneic keratinocyte sheets in conjunction with meshed split-thickness autografts | 3 months | Near complete healing except for minor blisters at edges of the split-thickness autografts | |
| DDEB | [32] | Case report | 1 | Allogeneic keratinocyte sheets in conjunction with meshed split-thickness autografts | 8–20 months | Complete epithelialisation at each of the two grafted sites after 8 and 10 months, respectively |
| JEB | [56] | Case report | 1 | Keratinocytes cultured on a feeder layer of murine fibroblasts into keratinocyte sheets | 8 months | All wounds remained completely epithelialised for 8 months; however, four grafting procedures were required. No further follow-up to assess long-term wound closure |
| [31] | Case report | 1 | 1 week | Significant epithelialisation over approximately 70% of the patient’s epidermis but only a 1-week follow-up reported. Renewed blistering and infections were observed at multiple graft sites | ||
| EBS | [23] | Case report | 1 | Commercially available epidermal allograft Kaloderm® (Tego Science, Seoul, Korea) consisting of allogeneic keratinocyte sheets | 3 weeks | Twice-weekly grafting resulted in a wound surface reduction of 50% but only over a short 3-week follow-up period |
C7 type VII collagen, DDEB dominant dystrophic epidermolysis bullosa, JEB junctional epidermolysis bullosa, RDEB recessive dystrophic epidermolysis bullosa, TESS tissue-engineered skin substitute