Organogenesis wins US OK for first cell-based mucogingival therapy
This article was originally published in Scrip
The US FDA on 9 March cleared Organogenesis' Gintuit for use as part of a surgical procedure to treat oral mucogingival, soft tissue defects involving the gums and other oral tissue at the juncture with the gingival.
The product is the first cell-based therapy made from allogeneic human cells and bovine collagen approved to treat mucogingival, US regulators said.
Gintuit consists of two layers: an upper layer formed by human keratinocytes – the primary cell type in the skin’s outer layer – and the lower layer constructed of bovine-derived collagen, human extracellular matrix proteins and human dermal fibroblasts, or skin cells that generate connective tissue.
The product secretes human growth factors and other proteins known to be involved in wound repair and regeneration.
The efficacy of Gintuit was evaluated in two studies in adults with insufficient gingival tissue. In each of the two studies, Gintuit was associated with an increase of at least 2mm of gingival tissue in at least 50% of study participants.
The most common adverse reactions associated with Gintuit were sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and local surgery site reactions, such as pain and redness.
Dr Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said Gintuit provides an alternative treatment to the current standard of care for gingival conditions, which may be caused by anatomic, traumatic or infection-related factors and are generally associated with a loss of sufficient amounts of attached gingival tissue..