{"id":"exoflo","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or swelling"},{"rate":null,"effect":"Mild inflammatory response"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ExoFlo consists of allogeneic bone marrow-derived mesenchymal stem cell exosomes that carry bioactive molecules including proteins, lipids, and nucleic acids. These exosomes are designed to modulate the immune response, reduce inflammation, and promote tissue regeneration and healing in damaged tissues.","oneSentence":"ExoFlo is an exosome-based therapeutic that delivers regenerative factors to promote tissue repair and reduce inflammation.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:11:59.095Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoarthritis of the knee"},{"name":"Chronic wounds and tissue repair"}]},"trialDetails":[{"nctId":"NCT05354141","phase":"PHASE3","title":"Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)","status":"RECRUITING","sponsor":"Direct Biologics, LLC","startDate":"2022-07-01","conditions":"Acute Respiratory Distress Syndrome, ARDS","enrollment":970},{"nctId":"NCT05836883","phase":"PHASE1, PHASE2","title":"Study of ExoFlo for the Treatment of Perianal Fistulas","status":"TERMINATED","sponsor":"Direct Biologics, LLC","startDate":"2023-08-28","conditions":"Perianal Fistula, Crohn's Disease","enrollment":5},{"nctId":"NCT05130983","phase":"PHASE1","title":"Study of ExoFlo for the Treatment of Medically Refractory Crohn's Disease","status":"TERMINATED","sponsor":"Direct Biologics, LLC","startDate":"2023-01-23","conditions":"Crohn Disease, Inflammatory Bowel Diseases","enrollment":3},{"nctId":"NCT05176366","phase":"PHASE1","title":"Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis","status":"TERMINATED","sponsor":"Direct Biologics, LLC","startDate":"2022-12-19","conditions":"Ulcerative Colitis, Inflammatory Bowel Diseases","enrollment":4},{"nctId":"NCT05116761","phase":"PHASE1, PHASE2","title":"ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome","status":"WITHDRAWN","sponsor":"Direct Biologics, LLC","startDate":"2024-11","conditions":"Covid19, Postviral Syndrome, Dyspnea","enrollment":""},{"nctId":"NCT04657458","phase":"","title":"Expanded Access for Use of bmMSC-Derived Extracellular Vesicles in Patients With COVID-19 Associated ARDS","status":"NO_LONGER_AVAILABLE","sponsor":"Direct Biologics, LLC","startDate":"","conditions":"Covid19, ARDS, Hypoxia","enrollment":""},{"nctId":"NCT05215288","phase":"","title":"Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients","status":"NO_LONGER_AVAILABLE","sponsor":"Direct Biologics, LLC","startDate":"","conditions":"Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection","enrollment":""},{"nctId":"NCT05127122","phase":"PHASE1, PHASE2","title":"Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS","status":"WITHDRAWN","sponsor":"Direct Biologics, LLC","startDate":"2024-12","conditions":"ARDS, Human","enrollment":""},{"nctId":"NCT04493242","phase":"PHASE2","title":"Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS","status":"COMPLETED","sponsor":"Direct Biologics, LLC","startDate":"2020-09-24","conditions":"COVID-19, ARDS","enrollment":102},{"nctId":"NCT05125562","phase":"PHASE2","title":"Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19","status":"WITHDRAWN","sponsor":"Direct Biologics, LLC","startDate":"2022-12-07","conditions":"COVID-19","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"ExoFlo","genericName":"ExoFlo","companyName":"Direct Biologics, LLC","companyId":"direct-biologics-llc","modality":"Biologic","firstApprovalDate":"","aiSummary":"ExoFlo is an exosome-based therapeutic that delivers regenerative factors to promote tissue repair and reduce inflammation. Used for Osteoarthritis of the knee, Chronic wounds and tissue repair.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}