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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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GINTUIT - Questions and Answers

 

  1. What is GINTUIT?
 
Gintuit is the first FDA approved cell-based product, made from allogeneic human cells and bovine collagen, indicated “for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.”
 
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 is not intended to provide dental root coverage. 
 
Note: The term “allogeneic” refers to cells derived from a donor source that is unrelated to the intended recipient. The term “mucogingival” refers to the oral mucosa and gingival (gum) tissues of the mouth.
 
  1. How is GINTUIT used?
 
The treatment regimen is a single application of GINTUIT over a surgically created vascular wound bed in the mouth. Additional information regarding the administration of GINTUIT can be found in the Dosage and Administration section of the approved labeling (see product link below).
  
  1. What are the ingredients in GINTUIT?
 
GINTUIT is a cellular sheet that consists of two layers, an upper layer comprised 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 proteins, and living human dermal fibroblasts (skin cells that generate connective tissues). 
 
  1. How Does GINTUIT work?
 
The mechanism of action by which GINTUIT works to increase keratinized tissue has not been identified.
 
In vitro studies have demonstrated that GINTUIT secretes human growth factors and cytokines, and contains extracellular matrix proteins. These factors are known to be involved in wound repair and regeneration.
 
  1. How was safety and efficacy demonstrated? 
 
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 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.
 
  1. What are the common adverse reactions observed with GINTUIT? 
 
Common adverse reactions observed during clinical trials with GINTUIT included 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. Additional information on adverse reactions can be found in the approved labeling.
 
  1. Who should not receive GINTUIT?
 
GINTUIT should not be used in patients who have oral infections or in patients with known allergies to bovine collagen.
 
  1. Where can I find additional information on GINTUIT?