{"id":"skinte","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection at application site"},{"rate":null,"effect":"Graft failure or poor integration"},{"rate":null,"effect":"Scarring"}]},"_chembl":null,"_dailymed":{"setId":"f8366a24-06ac-4417-a1fc-ea7338a0781d","title":"SKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"SkinTE uses a patient's own skin cells (keratinocytes and fibroblasts) to create a living tissue construct that mimics natural skin architecture. The engineered tissue is applied directly to wounds or burns, where it integrates with the patient's remaining tissue and promotes healing through cellular regeneration and restoration of skin barrier function.","oneSentence":"SkinTE is a living, autologous skin tissue engineered from a patient's own cells to regenerate functional skin for wound healing and burn treatment.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:34:52.499Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute thermal burns"},{"name":"Chronic wounds"}]},"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":"NCT03881267","phase":"NA","title":"SkinTE® in the Treatment of Venous Leg Wounds","status":"COMPLETED","sponsor":"PolarityTE","startDate":"2019-03-29","conditions":"Venous Leg Ulcer, Venous Stasis, Venous Stasis Ulcer","enrollment":29},{"nctId":"NCT03881254","phase":"NA","title":"SkinTE™ in the Treatment of Diabetic Foot Wounds","status":"COMPLETED","sponsor":"PolarityTE","startDate":"2019-04-02","conditions":"Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot","enrollment":100}],"_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":["Autologous Heterogeneous Skin Construct"],"phase":"marketed","status":"active","brandName":"SkinTE","genericName":"SkinTE","companyName":"PolarityTE","companyId":"polarityte","modality":"Biologic","firstApprovalDate":"","aiSummary":"SkinTE is a living, autologous skin tissue engineered from a patient's own cells to regenerate functional skin for wound healing and burn treatment. Used for Acute thermal burns, Chronic wounds.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}