{"id":"autologous-cultured-keratinocyte-cell","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection at graft site"},{"rate":null,"effect":"Graft failure or poor take"},{"rate":null,"effect":"Scarring"},{"rate":null,"effect":"Contracture"}]},"_chembl":{"chemblId":"CHEMBL5315092","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This cell therapy involves harvesting keratinocytes from a patient's own skin, expanding them in culture, and then delivering them back to the patient to cover wounds or damaged skin areas. The cells promote re-epithelialization, restore the skin barrier, and stimulate natural healing processes. This autologous approach minimizes immune rejection risk since the cells are derived from the patient themselves.","oneSentence":"Autologous cultured keratinocytes are patient-derived skin cells grown in vitro and applied topically or as a graft to promote wound healing and tissue regeneration.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:59.678Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Severe burns"},{"name":"Chronic wounds"},{"name":"Diabetic ulcers"}]},"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":"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":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Keraheal"],"phase":"phase_3","status":"active","brandName":"Autologous cultured keratinocyte cell","genericName":"Autologous cultured keratinocyte cell","companyName":"Biosolution Co., Ltd.","companyId":"biosolution-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Autologous cultured keratinocytes are patient-derived skin cells grown in vitro and applied topically or as a graft to promote wound healing and tissue regeneration. Used for Severe burns, Chronic wounds, Diabetic ulcers.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}