Allogeneic cultured keratinocytes and fibroblasts in bovine collagen

Allogeneic cultured keratinocytes and fibroblasts in bovine collagen, sold under the brand name Gintuit, is a cellular therapy used for the treatment of mucogingival conditions.
Common adverse reactions observed during clinical trials include sinusitis, nasopharyngitis, and local surgery site reactions such as pain and redness.
Allogeneic cultured keratinocytes and fibroblasts in bovine collagen is a cellular sheet that consists of two layers, an upper layer composed of living human keratinocytes and a lower layer constructed of bovine-derived collagen, human extracellular matrix proteins, and living human dermal fibroblasts. It is the first cell-based product made from allogeneic human cells and bovine collagen approved by the US Food and Drug Administration. It was approved for medical use in the United States in March 2012.

Medical uses

Allogeneic cultured keratinocytes and fibroblasts in bovine collagen is indicated for topical application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.

History

The efficacy of allogeneic cultured keratinocytes and fibroblasts in bovine collagen was evaluated in two clinical studies in adults with insufficient gingival tissue. In each of the two studies, Gintuit was associated with an increase of at least 2 mm of gingival tissue in at least 50% of the study subjects. The overall clinical trial safety data for Gintuit included 121 subjects from both studies.