Tissue-Engineered Skin (Apligraf) in the Healing of Patients With Epidermolysis Bullosa Wounds

Abstract

Background: At present, wound treatment of inherited epidermolysis bullosa (EB) is only supportive.Objective: To determine the safety and clinical effects of tissue-engineered skin (Apligraf; Organogenesis Inc, Canton, Mass) in the healing of wounds of patients with different types of EB.Design: An open-label uncontrolled study of 15 patients with EB treated with tissue-engineered skin. Each patient received tissue-engineered skin on up to 2 wounds on each of 3 clinic visits: day 1, week 6, and week 12. They were evaluated 7 ( ± 3) days and 6 weeks after each round of treatment. A quality-of-life survey was administered during week 6.

Purified Type I Collagen Wound Matrix Improves Chronic Wound Healing in Patients with Recessive Dystrophic Epidermolysis Bullosa

“…Most (85.7%) evaluable subjects saw improvement, and 42.8% had complete reepithelialization. Our results were similar to those of the Apligraf study, which showed that 44% of chronic EB wounds had complete healing after 6 weeks . A systematic analysis of multiple collagen products used for diabetic foot ulcers revealed that 58% of collagen‐treated wounds healed completely , although the rate of epithelialization ranged from 0% to 100%.…”

Safety and Wound Outcomes Following Genetically Corrected Autologous Epidermal Grafts in Patients With Recessive Dystrophic Epidermolysis Bullosa

“…Genetically corrected keratinocytes regenerated functional, self-renewing epidermis in 67% of graft sites tested at 6 months after grafting with type VII collagen or morphologically normal anchoring fibrils detectable up to 1 year for 3 patients (Figure 1 and Figure 2). These results are an improvement compared with previous studies of nongenetically modified allogenic keratinocyte grafts in which only 22% (2/9) chronic wounds showed healing at 18 weeks …”

Evaluation of Apligraf® persistence and basement membrane restoration in donor site wounds: a pilot study

“…Phillips et al concluded that there is no association between the clinical appearance of the treated wound and Apligraf s persistence. 8 Our study, using RT-PCR technology on sample biopsy of the treatment site (similar to methods used in previous studies), 8,13 showed that either the keratinocytes or fibroblasts of Apligraf s may persist for 4 weeks. It is plausible that Apligraf s or AWE DNA may have persisted in the unbiopsied area of the treatment sites; however, assessment of the entire grafted or treated area was prevented by Institutional Review Board constraints.…”

“…Human studies have not found measurable anti‐HLA antibody response to the allogeneic fibroblasts or keratinocytes, or antibody response to bovine collage type 1. The evaluated patients also did not exhibit T‐cell‐specific response to these components of Apligraf ® 13,21,22 . Additionally, in large clinical trials, no clinical rejection of the graft has been reported 11,13,22 .…”