Cell-Based Product for Regenerating Gum Tissue Okayed

Disclosures

March 09, 2012

March 9, 2012 — The US Food and Drug Administration (FDA) today approved the first cell-based product to repair gum problems, allowing oral surgeons and periodontists to regenerate gum tissue instead of repairing defects with tissue harvested from the patient's mouth.

The product, called Gintuit (Organogenesis), consists of both allogeneic human cells taken from a donor unrelated to the patient and bovine collagen. It is indicated for topical applications to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.

Geoff MacKay, the president and chief executive officer of Organogenesis, told Medscape Medical News that a major application of the product will be for treating gum recession around teeth. The standard of care, MacKay said, has been for periodontists and oral surgeons to graft tissue taken from the patient's palate. Tissue regeneration makes the repair less invasive and solves the problem of the palate sometimes not being able to supply enough graft material to replace all the missing tissue.

Other applications allowed under the FDA's indication are regenerating gum tissue around dental implants and over the edentulous ridge when teeth are missing. The use of the new product in these situations can replace gingival graft surgery, according to MacKay.

Gintuit is a 2-layer cellular sheet. The upper layer consists of human keratinocytes, and the lower layer is built with bovine-derived collagen, human extracellular matrix proteins, and human dermal fibroblasts that make connective tissue.

The FDA declared the product safe and effective on the basis of 2 clinical studies in adults with insufficient gum tissue. In each study, gum tissue increased by at least 2 mm in at least 50% of the patients.

The most common adverse reactions were sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and pain and redness around surgical sites.

More information on today's FDA decision is available on the agency's Web site.

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