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.