{{Short description|Medication}} {{Use American English|date=April 2023}} {{Use dmy dates|date=April 2023}} {{Infobox drug | drug_name = | INN = | type = <!-- empty --> | image = | width = | alt = | caption =
<!-- Clinical data --> | pronounce = | tradename = Gintuit | Drugs.com = | MedlinePlus = | licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) --> | licence_EU = <!-- EMA uses INN (or special INN_EMA) --> | DailyMedID = Gintuit | licence_US = <!-- FDA may use generic or brand name (generic name preferred) --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU_comment = | pregnancy_category = | routes_of_administration = Topical | class = | ATCvet = | ATC_prefix = None | ATC_suffix = | ATC_supplemental = | biosimilars =
<!-- Legal status --> | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> | legal_AU_comment = | legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> | legal_BR_comment = | legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_CA_comment = | legal_DE = <!-- Anlage I, II, III or Unscheduled --> | legal_DE_comment = | legal_NZ = <!-- Class A, B, C --> | legal_NZ_comment = | legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Gintuit FDA label">{{cite web | title=Gintuit- allogeneic cultured keratinocytes and fibroblasts in bovine collagen cellular sheet | website=DailyMed | date=20 March 2012 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2dedbdf1-ba02-476c-94b5-80ee314d9c9f | access-date=23 April 2023 | archive-date=29 January 2023 | archive-url=https://web.archive.org/web/20230129134720/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2dedbdf1-ba02-476c-94b5-80ee314d9c9f | url-status=live }}</ref> | legal_EU = | legal_EU_comment = | legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> | legal_UN_comment = | legal_status = <!-- For countries not listed above -->
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'''Allogeneic cultured keratinocytes and fibroblasts in bovine collagen''', sold under the brand name '''Gintuit''', is a cellular therapy used for the treatment of mucogingival (the oral mucosa and gingival (gum) tissues of the mouth) conditions.<ref name="Gintuit FDA label" /><ref name="Gintuit Q&A" />
Common adverse reactions observed during clinical trials include 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.<ref name="Gintuit Q&A" />
Allogeneic cultured keratinocytes and fibroblasts in bovine collagen is a cellular sheet that consists of two layers, an upper layer composed 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 (molecules that support and give structure to cells), and living human dermal fibroblasts (skin cells that generate connective tissues).<ref name="Gintuit Q&A" /> It is the first cell-based product made from allogeneic (cells derived from a donor source that is unrelated to the intended recipient) human cells and bovine collagen approved by the US Food and Drug Administration (FDA).<ref name="Gintuit Q&A" /> It was approved for medical use in the United States in March 2012.<ref name="Gintuit FDA label" /><ref>{{cite web | title=Gintuit | website=U.S. Food and Drug Administration (FDA) | date=13 May 2022 | url=https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/gintuit-allogeneic-cultured-keratinocytes-and-fibroblasts-bovine-collagen | access-date=23 April 2023 | archive-date=15 March 2023 | archive-url=https://web.archive.org/web/20230315144355/https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/gintuit-allogeneic-cultured-keratinocytes-and-fibroblasts-bovine-collagen | url-status=live }}</ref><ref>{{cite web | title=2012 Biological License Application Approvals | publisher=Center for Biologics Evaluation and Research | date=16 February 2012 | url=http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm289008.htm | archive-url=https://wayback.archive-it.org/7993/20170112095217/http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm289008.htm | archive-date=12 January 2017 | url-status=dead | access-date=23 April 2023}}</ref><ref>{{cite press release | title=Organogenesis Inc. Announces FDA Approval of Gintuit for Oral Soft Tissue Regeneration | publisher=Organogenesis Inc. | via=PR Newswire | date=12 March 2012 | url=https://www.prnewswire.com/news-releases/organogenesis-inc-announces-fda-approval-of-gintuit-for-oral-soft-tissue-regeneration-142301665.html | access-date=23 April 2023 | archive-date=9 August 2022 | archive-url=https://web.archive.org/web/20220809211527/https://www.prnewswire.com/news-releases/organogenesis-inc-announces-fda-approval-of-gintuit-for-oral-soft-tissue-regeneration-142301665.html | url-status=live }}</ref><ref name="pmid22678374">{{cite journal | vauthors = Schmidt C | title = Gintuit cell therapy approval signals shift at US regulator | journal = Nature Biotechnology | volume = 30 | issue = 6 | pages = 479 | date = June 2012 | pmid = 22678374 | doi = 10.1038/nbt0612-479 | doi-access = free }}</ref>
== Medical uses == Allogeneic cultured keratinocytes and fibroblasts in bovine collagen is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.<ref name="Gintuit Q&A">{{cite web | title=Gintuit - Questions and Answers | website=U.S. Food and Drug Administration (FDA) | date=3 May 2022 | url=https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/gintuit-questions-and-answers | access-date=23 April 2023 | archive-date=26 January 2023 | archive-url=https://web.archive.org/web/20230126224923/https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/gintuit-questions-and-answers | url-status=live }} {{PD-notice}}</ref>
== History == The efficacy of allogeneic cultured keratinocytes and fibroblasts in bovine collagen (Gintuit) was evaluated in two clinical studies in adults with insufficient gingival tissue.<ref name="Gintuit Q&A" /> 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.<ref name="Gintuit Q&A" />
== References == {{reflist}}
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Category:Cell therapies