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FDA NEWS RELEASE

For Immediate Release: March 9, 2012
Media Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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


The Food and Drug Administration today approved GINTUIT, the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. GINTUIT is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.

GINTUIT is used as part of a surgical procedure to treat mucogingival conditions. The treatment regimen is a single application of GINTUIT over a surgically created vascular wound bed in the mouth.

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. These conditions 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,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. 

GINTUIT is a cellular sheet that contains allogeneic human cells and bovine collagen for topical application in the mouth. GINTUIT consists of two 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).

While the specific way GINTUIT increases keratinized tissue has not been identified, 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 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 millimeters of gingival tissue in at least 50 percent 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.

GINTUIT is manufactured by Organogenesis Inc., based in Canton, Mass.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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