About ATMPs, SOPs and GMP: The Hurdles to Produce Novel Skin Grafts for Clinical Use.

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Med Etika Bioet (2005) 17.18

Lost in translation: animal models and clinical trials in cancer treatment. Am J Transl Res (2014) 1.63

Giant naevus, giant excision, eleg(i)ant closure? Reconstructive surgery with Integra Artificial Skin to treat giant congenital melanocytic naevi in children. J Plast Reconstr Aesthet Surg (2009) 1.22

Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems. Cell Tissue Bank (2013) 1.21

Integra Artificial Skin for burn scar revision in adolescents and children. Burns (2009) 1.08

Seven years' experience with Integra as a reconstructive tool. J Burn Care Res (2007) 1.02

An objective long-term evaluation of Integra (a dermal skin substitute) and split thickness skin grafts, in acute burns and reconstructive surgery. Burns (2009) 1.01

Dermal substitution in acute burns and reconstructive surgery: a 12-year follow-up. Plast Reconstr Surg (2010) 1.00

Regulation of advanced therapy medicinal products in Europe and the role of academia. Cytotherapy (2013) 0.98

Matriderm® 1 mm versus Integra® Single Layer 1.3 mm for one-step closure of full thickness skin defects: a comparative experimental study in rats. Pediatr Surg Int (2012) 0.93

The current status of orphan drug development in Europe and the US. Intractable Rare Dis Res (2014) 0.89

European Medicines Agency, CAT Secretariat & US Food and Drug Administration. Regen Med (2011) 0.86

Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med (2013) 0.84

Contracture of skin graft in human burns: effect of artificial dermis. Burns (2014) 0.84

Matriderm® in depth-adjusted reconstruction of necrotising fasciitis defects. Burns (2010) 0.82

The advanced therapy classification procedure. Overview of experience gained so far. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz (2011) 0.81

Single-stage Matriderm® and skin grafting as an alternative reconstruction in high-voltage injuries. Int Wound J (2010) 0.81

Collagen hydrogels strengthened by biodegradable meshes are a basis for dermo-epidermal skin grafts intended to reconstitute human skin in a one-step surgical intervention. J Tissue Eng Regen Med (2012) 0.81

Skingineering I: engineering porcine dermo-epidermal skin analogues for autologous transplantation in a large animal model. Pediatr Surg Int (2011) 0.79

Tissue-engineered dermo-epidermal skin analogs exhibit de novo formation of a near natural neurovascular link 10 weeks after transplantation. Pediatr Surg Int (2014) 0.79

Skingineering II: transplantation of large-scale laboratory-grown skin analogues in a new pig model. Pediatr Surg Int (2011) 0.78

Characterization of pigmented dermo-epidermal skin substitutes in a long-term in vivo assay. Exp Dermatol (2015) 0.78

FMEA and consideration of real work situations for safer design of production systems. Int J Occup Saf Ergon (2016) 0.77

Differential expression of granulocyte, macrophage, and hypoxia markers during early and late wound healing stages following transplantation of tissue-engineered skin substitutes of human origin. Pediatr Surg Int (2014) 0.77

Tissue-Engineered Skin Substitutes. Plast Reconstr Surg (2015) 0.77

Encountering Challenges with the EU Regulation on Advance Therapy Medical Products. Eur J Health Law (2015) 0.77

Novel treatment for massive lower extremity avulsion injuries in children: slow, but effective with good cosmesis. Eur J Pediatr Surg (2010) 0.77