Allogeneic cultured keratinocytes and fibroblasts in bovine collagen, sold under the brand name Gintuit, is a
cellular therapy used for the treatment of mucogingival (the
oral mucosa
The oral mucosa is the mucous membrane lining the inside of the mouth. It comprises stratified squamous epithelium, termed "oral epithelium", and an underlying connective tissue termed '' lamina propria''. The oral cavity has sometimes been des ...
and
gingival (gum) tissues of the mouth) conditions.
Common adverse reactions observed during clinical trials include sinusitis (sinus inflammation), nasopharyngitis (inflammation of the upper throat, upper respiratory tract infection, aphthous stomatitis (canker sores), 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 (the primary cell type in the skin's outer layer) and a lower layer constructed of bovine-derived collagen, human
extracellular matrix protein
In biology, the extracellular matrix (ECM), also called intercellular matrix (ICM), is a network consisting of extracellular macromolecules and minerals, such as collagen, enzymes, glycoproteins and hydroxyapatite that provide structural and bio ...
s (molecules that support and give structure to cells), and living human dermal fibroblasts (skin cells that generate connective tissues).
It is the first cell-based product made from allogeneic (cells derived from a donor source that is unrelated to the intended recipient) human cells and bovine collagen approved by the US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA).
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
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
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History
The efficacy of allogeneic cultured keratinocytes and fibroblasts in bovine collagen (Gintuit) 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.
References
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Cell therapies