{"id":"cultured-autologous-keratinocytes","safety":{"commonSideEffects":[{"rate":null,"effect":"Graft failure or poor integration"},{"rate":null,"effect":"Infection at graft site"},{"rate":null,"effect":"Contracture formation"},{"rate":null,"effect":"Hypertrophic scarring"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This therapy involves harvesting a small sample of the patient's own keratinocytes (skin cells), expanding them in culture to create a large sheet of living skin tissue, and then grafting this autologous cellular product onto burn wounds. The cultured keratinocytes restore the epidermal barrier, promote wound closure, reduce infection risk, and facilitate natural healing by providing viable skin cells that integrate with the patient's existing tissue.","oneSentence":"Cultured autologous keratinocytes are patient-derived skin cells grown in vitro and applied topically to promote wound healing and skin regeneration in severe burn injuries.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:12.129Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Severe thermal burns requiring skin grafting"}]},"trialDetails":[{"nctId":"NCT07222540","phase":"","title":"Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers","status":"TEMPORARILY_NOT_AVAILABLE","sponsor":"PolarityTE","startDate":"","conditions":"DFU, Neuropathic Diabetic Ulcer - Foot, Diabetic Foot Disease","enrollment":""},{"nctId":"NCT06140303","phase":"PHASE3","title":"SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)","status":"ACTIVE_NOT_RECRUITING","sponsor":"PolarityTE","startDate":"2024-02-22","conditions":"Diabetic Foot","enrollment":100},{"nctId":"NCT05372809","phase":"PHASE3","title":"Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs","status":"TERMINATED","sponsor":"PolarityTE","startDate":"2022-04-28","conditions":"Diabetic Foot","enrollment":42},{"nctId":"NCT05503368","phase":"NA","title":"Autologous Cellular Graft in Surgical Treatment of Vitiligo","status":"SUSPENDED","sponsor":"Cairo University","startDate":"2023-06","conditions":"Vitiligo, Generalized","enrollment":20},{"nctId":"NCT05652816","phase":"EARLY_PHASE1","title":"Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients","status":"UNKNOWN","sponsor":"Indonesia University","startDate":"2022-09-06","conditions":"Burn Degree Second, Burn Degree Third","enrollment":20},{"nctId":"NCT04485962","phase":"PHASE1, PHASE2","title":"Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts","status":"COMPLETED","sponsor":"Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus","startDate":"2017-01-01","conditions":"Burns","enrollment":12},{"nctId":"NCT03686449","phase":"NA","title":"Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Post-Burn Raw Area","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2020-11-01","conditions":"Burn With Full-Thickness Skin Loss","enrollment":33},{"nctId":"NCT00832156","phase":"PHASE3","title":"Application of Cultured Autologous Keratinocytes for Burn Wound Healing","status":"COMPLETED","sponsor":"Association of Dutch Burn Centres","startDate":"2008-06","conditions":"Burns","enrollment":40},{"nctId":"NCT03675568","phase":"NA","title":"Non-cultured Autologous Keratinocyte Suspension Versus Traditional Split Skin Graft for Burn Wounds Treatment","status":"WITHDRAWN","sponsor":"Assiut University","startDate":"2018-11-01","conditions":"Burn Wound","enrollment":""},{"nctId":"NCT01454687","phase":"NA","title":"Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes","status":"WITHDRAWN","sponsor":"Stanford University","startDate":"2011-10","conditions":"Epidermolysis Bullosa","enrollment":""},{"nctId":"NCT00587834","phase":"PHASE3","title":"Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue Regeneration","status":"COMPLETED","sponsor":"Organogenesis","startDate":"2007-10","conditions":"Gingival Recession","enrollment":96},{"nctId":"NCT01547962","phase":"NA","title":"A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached Gingiva","status":"COMPLETED","sponsor":"Organogenesis","startDate":"2005-09","conditions":"Gingival Recession","enrollment":25},{"nctId":"NCT00978705","phase":"PHASE3","title":"Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood","status":"UNKNOWN","sponsor":"Biosolution Co., Ltd.","startDate":"2007-11","conditions":"Burn Wound","enrollment":19},{"nctId":"NCT00718978","phase":"NA","title":"Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)","status":"COMPLETED","sponsor":"University of Roma La Sapienza","startDate":"2003-06","conditions":"Burns, Ulcers, Giant Nevi","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":49,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Cultured keratinocytes"],"phase":"phase_3","status":"active","brandName":"Cultured autologous keratinocytes","genericName":"Cultured autologous keratinocytes","companyName":"Association of Dutch Burn Centres","companyId":"association-of-dutch-burn-centres","modality":"Biologic","firstApprovalDate":"","aiSummary":"Cultured autologous keratinocytes are patient-derived skin cells grown in vitro and applied topically to promote wound healing and skin regeneration in severe burn injuries. Used for Severe thermal burns requiring skin grafting.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}