FDA approves first cell-based product to treat oral mucogingival conditions in adults

FDA approved the first cell-based product made from allogeneic human cells and bovine collagen (Gintuit, Organogenesis) for the treatment of oral mucogingival conditions in adults, the agency announced Friday.

The treatment regimen for Gintuit is a single application over a surgically created vascular wound bed in the mouth. The human cells must be from a donor unrelated to the patient, FDA said.

Organogenesis CEO Geoff MacKay told Formulary that he believes FDA's action "is a landmark approval for multiple reasons. It the first-ever approval of a mass-produced allogeneic cell-based product via the CBER (Center for Biologics Evaluation and Research) arm of the FDA, and is also the first cell-based product FDA-approved for use in the dental market.

"This breakthrough product represents a completely new therapeutic class in dentistry," he added, "and we hope that it will eventually obviate the need for painful palate graft surgery.”

Mucogingival defects are soft tissue defects involving both the attached gingiva (gums) and other oral tissue at the juncture with the gingiva.

Conditions may be caused by anatomic, traumatic, or infection-related factors and are generally associated with a loss of sufficient amounts of attached gingival tissue to cause soft tissue inflammation that is not resolved by oral hygiene procedures alone.

“Gintuit provides an alternative treatment to the current standard of care for treatment of gingival conditions,” FDA's Karen Midthun, MD, director of CBER, said in a press release.

Gintuit consists of 2 layers. The upper layer is formed by human keratinocytes (the primary cell type in the skin’s outer layer) and the lower layer is constructed of bovine-derived collagen, human extracellular matrix proteins, and human dermal fibroblasts (skin cells that generate connective tissue).

Specifically how Gintuit increases keratinized tissue has not been identified, but studies have demonstrated that Gintuit secretes human growth factors and other proteins that are known to be involved in wound repair and regeneration.

The efficacy of Gintuit was evaluated in 2 clinical studies in adults with insufficient gingival tissue. In each of the 2 studies, Gintuit was associated with an increase of at least 2 millimeters of gingival tissue in at least 50% of study subjects.

The most common adverse reactions were sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and local surgery-site reactions, such as pain and redness.More information is available on the Organogenesis website.