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What is Keratinocytes Fibroblasts Collagen
Keratinocytes Fibroblasts Collagen (Gintuit) is a sterile, topically applied scaffold product that contains allogeneic human cells, human extracellular matrix proteins, and bovine collagen.
This product is used in the oral cavity in the treatment of mucogingival conditions in adults.
Keratinocytes Fibroblasts Collagen is available as a ready-to-use circular cellular sheet that, when placed (non-submerged) onto a surgically created vascular wound bed, forms a soft cohesive network of fibers that increase keratinized tissue.
The product improves healing, allowing the regeneration of aesthetically appealing tissue that has the same color and texture of the surrounding tissues; the treatment may also preclude the need for patient-donated tissue grafts. In clinical evaluation, the product formed keratinized tissue that was non-inferior to soft tissue grafting. Further, because Keratinocytes; Fibroblasts; Collagen contains bovine collagen, patients with known allergies to bovine collagen should not use this product.
The FDA approved Gintuit in March 2012. Gintuit represents the first approval of an allogenic cell product via the FDA’s Center for Biologics Evaluation and Research, and the first cell-based technology for use in the dental market.
Indications
- mucogingival conditions
For the treatment of mucogingival conditions
Side Effects
The most common adverse reactions to Keratinocytes; Fibroblasts; Collagen (Gintuit) observed in the clinical trials (>= 1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous ulcer or stomatitis, and the local effects of oral surgery.
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- bovine protein hypersensitivity
- breast-feeding
- children
- fungal infection
- geriatric
- infants
- infection
- neonates
- new primary malignancy
- pregnancy
- viral infection
Interactions
No information is available regarding drug interactions associated with Keratinocytes Fibroblasts Collagen
