GEN Exclusives

More »

GEN News Highlights

More »
Mar 12, 2012

FDA Approves Organogenesis’ Gintuit Cell-Based Product for Gum Disease

  • FDA approved Organogenesis’ cell product Gintuit™ (allogeneic cultured keratinocytes and fibroblasts in bovine collagen) for the regeneration of oral soft tissue. The firm says clearance in the U.S. is the first for an allogeneic cell product via FDA’s Center for Biological Evaluation and Research (CBER), and also the first for a cell-based technology for use in dental applications.

    Gintuit consists of a cellular sheet comprising human fibroblasts, keratinocytes, human extracellular matrix proteins, and bovine collagen. The product is applied topically to a surgically created vascular wound bed, for the treatment of mucogingival conditions in adults. FDA clearance was based on data from a pivotal trial in patients with gingival recession, which showed that Gintuit-treated sites generated marked amounts of keratinized oral soft tissue. The Gintuit-generated tissue also more closely matched the patient’s surrounding tissue compared with traditional palatal grafting procedures.

    Regenerative medicine company Organogenesis is focused on the development of cell products for bioactive wound healing and oral regeneration. The firm’s flagship FDA-approved Apligraf® is a human cell-based therapy for the treatment of venous leg ulcers and diabetic foot ulcers. Organogenesis is separately continuing with late-stage development of VCT01™. The candidate is bilayered bioengineered skin, comprising a dermal matrix generated de novo from the human dermal fibroblasts, seeded with human keratinocytes.

    Organogenesis is in the process of constructing what it claims will represent the world’s largest automated living cell production plant in Massachusetts, and is due to be completed in 2013.

     


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

New Drugs for Ebola

Do you think that biopharma companies should not have to go through the normal drug approval process in order to get potential life-saving therapies to Ebola patients more quickly?