{"id":"grafixpl-prime","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection at wound site"},{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Delayed wound healing"}]},"_chembl":{"chemblId":"CHEMBL2109456","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This product is composed of dehydrated human amniotic membrane and umbilical cord tissue that contains native extracellular matrix components, growth factors, and anti-inflammatory cytokines. When applied to wounds, it provides a protective barrier, delivers bioactive molecules to the wound bed, and facilitates the body's natural healing processes through tissue regeneration rather than acting as a traditional pharmaceutical agent.","oneSentence":"GrafixPL PRIME is a placental tissue-derived allograft that provides a biological scaffold and growth factors to promote wound healing and tissue regeneration.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:31:24.570Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers)"},{"name":"Acute wounds and surgical wounds"},{"name":"Burn wounds"}]},"trialDetails":[{"nctId":"NCT03742440","phase":"PHASE4","title":"GrafixPL PRIME Evaluation Case Study","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2018-11-20","conditions":"Diabetic Foot Ulcer","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"GrafixPL PRIME","genericName":"GrafixPL PRIME","companyName":"University of Texas Southwestern Medical Center","companyId":"university-of-texas-southwestern-medical-center","modality":"Biologic","firstApprovalDate":"","aiSummary":"GrafixPL PRIME is a placental tissue-derived allograft that provides a biological scaffold and growth factors to promote wound healing and tissue regeneration. Used for Chronic wounds (diabetic foot ulcers, venous leg ulcers, pressure ulcers), Acute wounds and surgical wounds, Burn wounds.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}