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FDA NEWS RELEASE4 N6 }; u( i* B0 z3 k1 F
For Immediate Release: March 9, 2012
( f1 y! j( V7 x/ lMedia Inquiries: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov! x+ U+ d, \- l' a3 l) j
Consumer Inquiries: 888-INFO-FDA# C* ~* t y; o5 P* h; x, @% u- B+ j! K* l
* {4 ^. a; W- bFDA approves first cell-based product to treat oral mucogingival conditions in adults$ q' U* O. s0 C+ U+ P0 ?" w
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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.
5 Y! b( c. X# Q# W6 { P7 F/ zGINTUIT 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.2 }5 [" r6 J, M2 G
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.! O5 a, o4 O* y2 Z' O4 x
“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.
a+ a- \* p! VGINTUIT 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).. m' U" ]8 ^: E) r/ N* ~4 `9 r
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.
4 |2 q( p9 A# v' v, w I; x8 D% LThe 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.3 }( ~2 U6 v {
The most common adverse reactions were sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and local surgery site reactions, such as pain and redness.% M8 g' w2 i8 Q* x: `
GINTUIT is manufactured by Organogenesis Inc., based in Canton, Mass.0 P8 t. {/ @2 p
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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ORGANOGENESIS INC. ANNOUNCES FDA APPROVAL OF GINTUIT™ FOR ORAL SOFT TISSUE REGENERATION
. b2 ] B$ l# h! c6 k6 R& l! p$ r9 \FDA Approval Marks First-Ever CBER-Approved Allogeneic Cell-Based Product3 l$ }# k7 L9 O" L5 R
Canton, Mass.– Monday, March 12, – Today Organogenesis Inc., a business leader in the regenerative medicine field, announced that the United States Food and Drug Administration (FDA) has approved GINTUIT™ (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), a cell-based product that has been shown to predictably generate new and aesthetically appealing oral soft tissue (gum tissue)., M' T/ z# ]: _* C# g- |$ t
The GINTUIT approval marks two important firsts: the first-ever approval of an allogeneic cell product via the Center for Biologics Evaluation and Research (CBER) arm of the FDA, and the first cell-based technology that is FDA-approved for use in the dental market.
: z6 s: D- _! n5 U+ u"This FDA approval is a significant milestone for our company, for the FDA, and for the regenerative medicine and dental surgery fields," said Organogenesis President & CEO Geoff MacKay. "As a pioneer in regenerative medicine, Organogenesis continues to lead the way by ushering in a completely new therapeutic class in dentistry. Our second breakthrough cell-based product, GINTUIT will help dental surgeons generate new gum tissue for their patients without turning to palate graft surgery."
) N3 y) O& ~0 m% f3 |! qGINTUIT is a cellular sheet that contains human fibroblasts, keratinocytes, human extracellular matrix proteins and bovine collagen. These cells produce a wide array of cytokines and growth factors, signals that allow cells to communicate with each other. These proteins are important factors for the healing and regeneration of tissue.
7 j7 O5 f: u6 N5 O"Anyone who has experienced the discomfort of palatal graft surgery will immediately recognize the benefits of a product that has been shown to generate new gum tissue, and importantly, does not require excision of tissue from the roof of a patient's mouth," continued Mr. MacKay.
. @ x' V' Y9 y2 d8 D0 H+ GOrganogenesis completed a multi-center, randomized, pivotal clinical trial to determine the efficacy and safety of GINTUIT to regenerate oral soft tissue in patients with gingival recession. The GINTUIT-treated sites generated a clinically significant amount of keratinized oral soft tissue. Moreover, GINTUIT-generated gum tissue better matched the color and texture of the patient's surrounding tissue versus traditional palatal grafting procedures. Importantly, patients overwhelmingly preferred GINTUIT over the grafting procedure when taking into consideration all aspects of treatment (surgery, recovery, appearance). - O; l0 h% f& ^5 g& Z M
In clinical trials, GINTUIT was considered safe and well tolerated. The most common adverse reactions observed in the clinical trials (≥1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery.
% y5 H# Y% m9 r( X/ U) Z9 E2 a% o6 u"Healthy gingiva or gum tissue is important for protecting teeth and dental implants. The loss of keratinized gingiva is a very common, yet serious, problem," said Dr. Michael K. McGuire, the lead investigator of the GINTUIT pivotal trial and a pioneer in the use of tissue engineering technologies in periodontology. "GINTUIT holds the promise of rewriting the rules of regeneration. Delivering a construct with living cells that can generate new tissue indistinguishable from what nature intended is unprecedented and exciting."
4 r6 R3 \* C+ ^; p, j% T! S5 LOrganogenesis expects that GINTUIT will be commercially available via a controlled market release beginning in the summer of 2012 and available to the broader U.S. market in 2013.. @! p: {, q4 P3 H
The latest FDA approval comes at a time of rapid growth and development for Organogenesis. The company is currently in the midst of a major, multi-year expansion of its global headquarters, research and development, and manufacturing facilities in Massachusetts.; o- }3 W! e4 _" D% ? o4 K( e* T
"In addition to this FDA approval, the company has reached a number of important landmarks in the past twelve months," said Mr. MacKay. "We broke ground on our new state-of-the-art regenerative medicine manufacturing facility, and we hired our 500th employee. This is truly an exciting time for our trailblazing company."7 v) V* b6 X: u
About GINTUIT™ R4 x* ^' H3 v
GINTUIT™ is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. GINUIT is not intended to provide root coverage.
$ }* Y8 u# E6 r5 Q( V5 ZThe most common adverse reactions observed in the clinical trials (≥1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery.
2 X2 O4 ~ n) R0 qAbout Organogenesis, Inc. # @* ~. k* T) j5 s, o0 b) @
Having pioneered the field, Massachusetts based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active wound healing and oral regeneration. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit www.organogenesis.com.# ]" z, F0 z1 I6 w4 {
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发表于 2012-3-13 11:02
