Drug intelligence / Profile preview

allogeneic cultured keratinocytes and fibroblasts in bovine collagen

Development stage
Approved
Lead developer
Organogenesis
Modality
Implantable Hydrogels → Hydrogel Systems → Drug Delivery Systems, Implantable Devices → Device-based Delivery → Drug Delivery Systems, Cell Therapies, Recombinant Proteins and Enzymes, Injectable Hydrogels → Hydrogel Systems → Drug Delivery Systems
Administration
Topical
01

Overview

Gintuit is an allogeneic cellularized scaffold product composed of a bilayered sheet containing allogeneic human keratinocytes, dermal fibroblasts, human extracellular matrix proteins, and bovine type I collagen. It is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the oral cavity for the treatment of mucogingival conditions in adults. The product does not function as a tissue graft; instead, it provides a scaffold that supports wound healing and regeneration by delivering growth factors, cytokines, and extracellular matrix proteins involved in tissue repair. The active ingredients are derived from donated human newborn foreskin tissue (keratinocytes and fibroblasts) combined with bovine collagen[1][2][4][5]. The precise mechanism by which Gintuit increases keratinized tissue at the treated site has not been identified[1][8]. Gintuit is notable as the first FDA-approved cell-based technology for use in dental applications. It does not provide root coverage but generates new oral soft tissue that matches surrounding gum color and texture more closely than traditional grafts[5]. Its safety or efficacy with repeat applications has not been established.

Brand names
Gintuit
Other names
allogeneic cultured keratinocytes and fibroblasts in bovine collagenbovine type i collagen + foreskin keratinocyte (neonatal) + foreskin fibroblast (neonatal)

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