Allogeneic Cultured Cell Scaffold

DrugDrug NameDrug Indication
DB10770Foreskin fibroblast (neonatal)This device is indicated for use for the treatment of full-thickness, diabetic foot ulcers greater than six weeks duration which extends through the dermis, but without tendon, muscle, joint capsule or bone exposure. This drug should be used in conjunction with standard wound care regimens and in patients with an adequate blood supply to the involved foot [L2418].
DB10771Bovine type I collagenFor the management of wounds including: partial and full- thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh’s dermatological surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds [L2500]. Gintuit (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. It uses bovine collagen as a matrix to support the growth of keratinocytes and fibroblasts in wound healing [L2450]. Other products using bovine type 1 collagen include PriMatrix, Integra, Orcel and Matriderm [L2490]. Orcel is a bilayered cellular matrix in which normal human allogeneic skin cells (both epidermal keratinocytes and dermal fibroblasts) are cultured in two separate layers into a Type I bovine collagen sponge, indicated in venous leg ulcers and diabetic foot. Type I bovine collagen acts as a matrix for the growth and proliferation of fibroblasts and keratinocytes, offering structure and support [L2427]. In the laboratory, bovine Collagen Type I purified protein standard is used as a control for SDS-PAGE, Western Blot, ELISA, immunoprecipitation, and for other immunological assays [L2488].
DB10772Foreskin keratinocyte (neonatal)For chronic leg ulcers and diabetic foot [L2439]. Orcel is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month in duration and which have not effectively responded to conventional ulcer therapy. Orcel is also for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than 3 weeks in duration which have not effectively responded to conventional ulcer therapy, and which extend through the dermis but without tendon, muscle, capsule or bone involvement [L2459].
DrugDrug NameTargetType
DB10770Foreskin fibroblast (neonatal)Interleukin-6target
DB10770Foreskin fibroblast (neonatal)Vascular endothelial growth factor receptor 1target
DB10770Foreskin fibroblast (neonatal)Interleukin-1 receptor type 1target
DB10770Foreskin fibroblast (neonatal)TGF-beta receptor type-2target
DB10770Foreskin fibroblast (neonatal)Fibroblast growth factor 1target
DB10770Foreskin fibroblast (neonatal)Interferon gammatarget
DB10770Foreskin fibroblast (neonatal)Fibroblast growth factor receptor 2target
DB10770Foreskin fibroblast (neonatal)Granulocyte-macrophage colony-stimulating factor receptor subunit alphatarget
DB10770Foreskin fibroblast (neonatal)Platelet-derived growth factor receptor betatarget
DB10770Foreskin fibroblast (neonatal)Transforming growth factor beta-1target
DB10770Foreskin fibroblast (neonatal)Tumor necrosis factortarget
DB10772Foreskin keratinocyte (neonatal)Fibroblast growth factor 1target
DB10772Foreskin keratinocyte (neonatal)Epidermal growth factor receptortarget
DB10772Foreskin keratinocyte (neonatal)Granulocyte-macrophage colony-stimulating factor receptor subunit alphatarget
DB10772Foreskin keratinocyte (neonatal)Interleukin-1 betatarget
DB10772Foreskin keratinocyte (neonatal)Interleukin-6target
DB10772Foreskin keratinocyte (neonatal)Interferon gammatarget
DB10772Foreskin keratinocyte (neonatal)Fibroblast growth factor receptor 2target
DB10772Foreskin keratinocyte (neonatal)Platelet-derived growth factor receptor alphatarget
DB10772Foreskin keratinocyte (neonatal)TGF-beta receptor type-2target
DB10772Foreskin keratinocyte (neonatal)Transforming growth factor beta-1target
DB10772Foreskin keratinocyte (neonatal)Tumor necrosis factortarget
DB10772Foreskin keratinocyte (neonatal)Vascular endothelial growth factor Atarget