A phase II randomized vehicle-controlled trial of intradermal allogeneic fibroblasts for recessive dystrophic epidermolysis bullosa.

[dystrophic epidermolysis bullosa]

Chronic wounds are a major source of morbidity and mortality in generalized severe recessive dystrophic epidermolysis bullosa (RDEB-GS ).This was a phase II double -blinded randomized controlled trial of intralesional allogeneic cultured fibroblasts in suspension solution versus suspension solution alone for wound healing in RDEB-GS .Adult patients with RDEB-GS were screened for chronic ulcers and reduced collagen VII expression . Up to 6 pairs of symmetric wounds were measured and biopsied at baseline , then randomized to cultured allogeneic fibroblasts in a crystalloid suspension solution with 2 % albumin or suspension solution alone . Ulcer size , collagen VII protein and messenger RNA expression , anchoring fibril numbers , morphology , and inflammatory markers were measured at 2 weeks and at 3 , 6 , and 12 months .All wounds healed significantly more rapidly with fibroblasts and vehicle injections , with an area decrease of 50 % by 12 weeks , compared with noninjected wounds . Collagen VII expression increased to a similar degree in both study arms in wounds from 3 of 5 patients .The number of patients with RDEB-GS who met inclusion criteria was a limitation , as was 1 trial center rather than multicenter .The injection of both allogeneic fibroblasts and suspension solution alone improved wound healing in chronic nonhealing RDEB-GS wounds independently of collagen VII regeneration . This may provide feasible therapy for wound healing in patients with RDEB-GS .

Diseases
Validation

Diseases presenting "reduced collagen vii expression" symptom

dystrophic epidermolysis bullosa

You can validate or delete this automatically detected symptom