[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Direct Biologics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642804","phase-2-db-3q-for-the-treatment-of-medically-refractory-crohns-disease-100642804",false,"NCT07625293","DB-3Q for the Treatment of Medically Refractory Crohn's Disease","A Phase 2a Study of DB-3Q for the Treatment of Medically Refractory Crohn's Disease","Inclusion Criteria:\n\n1. Written informed consent from participant\n2. Males and females 18-75 years of age\n3. Diagnosed with Crohn's disease of at least 6 months duration with medically refractory symptoms that failed to respond or responded but recurred after one advanced immunologic therapy (must have been receiving at least one advanced immunological therapy for 14 weeks duration prior to screening, including, but not limited to, adalimumab, certolizumab, , infliximab, risankizumab, upadacitinib, ustekinumab and vedolizumab), or is intolerant, or has a contraindication to advanced immunological therapy with a next step of subtotal colectomy or escalation in medical management\n4. Active CD as defined by a CDAI score ≥ 220 and\u002For SES-CD score ≥ 4\n5. Exposure to corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary\n6. If receiving conventional immunomodulators (i.e., azathioprine \\[AZA\\], mercaptopurine \\[6-MP\\], or methotrexate \\[MTX\\]), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks prior to initial administration of IMP\n7. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to initial administration of IMP\n8. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks. If receiving oral corticosteroids, the dose must be ≤20 mg\u002Fday prednisone or its equivalent and must have been stable for at least 4 weeks prior to initial administration of IMP\n9. If receiving budesonide, the dose must have been stable for at least 2 weeks prior to initial administration of IMP\n10. If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks prior to initial administration of IMP\n11. The following medications\u002Ftherapies must have been discontinued before initial administration of IMP:\n\n    1. Monoclonal therapy (e.g., adalimumab, certolizumab, infliximab, risankizumab, ustenkinumab, and vedolizumab) for at least 8 weeks\n    2. Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks\n    3. 6-thioguanine (6-TG) must have been discontinued for at least 4 weeks\n    4. JAK inhibitors (e.g., upadacitinib) must have been discontinued for at least 4 weeks\n    5. Rectal corticosteroids (i.e., corticosteroids \\[including budesonide\\] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks\n    6. Rectal 5-ASA compounds (i.e., 5-ASAs administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks\n    7. Parenteral corticosteroids for at least 2 weeks\n    8. Total parenteral nutrition for at least 2 weeks\n    9. Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks\n12. No colonic dysplasia and malignancy as ruled out by colonoscopy within 90 days prior to initial administration of IMP\n13. If participant is of reproductive capacity, willing to use adequate birth control measures while in the study\n\nExclusion Criteria:\n\n1. Lack of informed consent\n2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding\n3. Clinically significant medical conditions within the six months before initial administration of IMP: e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the participant\n4. Confirmed Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infections\n5. Aspartate aminotransferase (AST) or Alanine transaminase (ALT) greater than 3 times the upper limit of normal at screening\n6. Abnormal basic laboratory values with the following cut-offs:\n\n   1. Alkaline phosphate \\> 200 U\u002FL\n   2. WBC \\>13 109\u002FL\n   3. Hemoglobin \\\u003C 7 g\u002FdL\n   4. Platelets \\\u003C 50 or \\> 109\u002FL\n   5. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2\n   6. HbA1C \\> 8%\n7. Prothrombin time (PT), partial thromboplastin time (aPTT) or international normalized ratio (INR) greater than 1.5 times the upper limits of normal at screening\n8. Clinically significant abnormal vital signs prior to initial administration of IMP as defined by:\n\n   1. Systolic blood pressure \\>160 or \\\u003C90 mmHg\n   2. Diastolic blood pressure \\>90 or \\\u003C60 mmHg\n   3. Pulse \\\u003C55 or \\>105 bpm\n   4. Respiratory Rate (RR) \\\u003C9 and \\>25 breaths per minute\n   5. Temperature \\>100.4 degrees Fahrenheit\n   6. SpO2 \\\u003C92%\n9. History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment\n10. Ulcerative colitis or indeterminate colitis\n11. Suspicion or presence of an intraabdominal or perianal abscess\n12. Microscopic, ischemic or infectious colitis\n13. Neoplasia of the colon on preoperative biopsy\n14. Evidence of colonic perforation\n15. Colonic stricture that unable to pass an adult colonoscope\n16. Three or more prior small bowel resections\n17. Presence of an ostomy\n18. Massive hemorrhage from the colon requiring emergent surgery in the 6 months prior to screening\n19. Fulminant colitis requiring emergency surgery\n20. Concurrent active clostridium difficile infection of the colon\n21. Concurrent Cytomegalovirus infection of the colon via colonic biopsy with CMV stain taken within 90 days prior to screening\n22. Active or latent tuberculosis\n23. Unable to wean off corticosteroids\n24. Primary sclerosing cholangitis\n25. History of or current alcohol or drug abuse or dependence, recreational use of illicit drugs or prescription medications, or use of medical marijuana within 90 days prior to screening\n26. Known allergy to local anesthetics\n27. Concurrent use of anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix)\n28. History of known inherited or acquired hypercoagulable states.\n29. Electrocardiogram demonstrating cardiac arrhythmia, except for sinus tachycardia within the predefined limit of no greater than 105 bpm.\n30. Use of investigational therapy or treatment within 6 months prior to initial IMP administration","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.",[27],"Crohn Disease (CD)","NOT_YET_RECRUITING","2026-06-10",{"date":31,"type":32},"2026-06-12","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Direct Biologics, LLC","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100586702","phase-2-db-3q-bmmsc-evs-in-patients-with-perianal-fistulizing-crohns-disease-100586702","NCT06918808","DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease","A Phase 2a Study of Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product (DB-3Q) in Patients With Perianal Fistulizing Crohn's Disease","Inclusion Criteria:\n\n1. Written informed consent from participant\n2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1\n3. One or two perianal fistula(s) with 1 or two external openings, that are actively draining\n4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)\n5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula\n6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)\n7. Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) must have been stable for at least 2 weeks prior to Day 1\n8. Oral corticosteroids ≤ 20 mg\u002Fday prednisone or its equivalent and must have been stable for at least 4 weeks prior to Day 1\n9. Approval of a screening pelvic MRI by review of a central radiologist. The definition of an acceptable screening pelvic MRI is provided in the study imaging manual.\n10. Fulfillment of radiologic inclusion by a central radiologist. Radiologic inclusion on MRI is presence of 1 or 2 qualifying perianal fistula(s). Radiologic inclusion assesses anatomic criteria of a perianal fistula and study-defined imaging endpoint criteria. a. Anatomically, a qualifying perianal fistula on MRI fulfills the following from central radiologist assessment: i. has a communication with the internal sphincter of the anal canal ii. is classified as a Parks intersphincteric, transsphincteric, or suprasphincteric perianal fistula. b. For study imaging endpoints, a central radiologist confirms that a fistula has a minimum score of 7 (range 0 to 25) on MAGNIFI-CD and a fistula fibrosis -to-fluid ratio of less than 80%.25, 37 Within components of MAGNIFI-CD, the fistula has a length of 2.5 cm or greater and has a composition of either 'predominantly fluid\u002Fpus' or 'predominantly granulation tissue'. c. Within components of fistula fibrosis-to-fluid ratio, the ratio of hypointense scarring or fibrosis on MRI T2 weighted sequences to hyperintense fluid on MRI T2 weighted sequences is below 80%.25 The fistula is categorized into one of following ranges of fibrosis-to- fluid ratio: i) 0%, ii) 1-19%, iii) 20-39%, iv) 40-59%, or v) 60-79%\n\nExclusion Criteria\n\n1. Lack of informed consent\n2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding\n3. A participant who is unwilling to use medically acceptable contraception methods during participation in study\n4. Active perianal abscess or infection at screening or Day 1\n5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant\n6. Confirmed HIV, Hepatitis B, or Hepatitis C infections\n7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening\n8. History of colorectal cancer within 2 years of screening\n9. History of coagulation disorders and\u002For are currently on anti- coagulant therapy\n10. Presence of a recto\u002Fano-vaginal fistula\n11. Presence of an ileal anal pouch and\u002For history of proctectomy\n12. Presence of severe proctitis (SES CD \\>6)\n13. Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for participant to undergo MRI evaluations (i.e., presence of implantable or external MRI unsafe device that cannot be removed, body weight exceeding limitations, claustrophobia, etc.)\n14. The following out of range laboratory results at screening\n\n    * WBC \\> 13 x 109 \u002FL\n    * Hemoglobin \\\u003C 8 g\u002FdL\n    * Platelet count \\\u003C 100,000\u002FmL\n    * AST\u002FALT \\> 3 times the upper limit of normal\n    * Creatinine \\> 2 μmol\u002FL\n    * PT\u002FINR: 2 times the upper limit of normal\n    * Hemoglobin A1c \\> 6.5 mg\u002FdL\n15. Use of investigational therapy or treatment within 30 days prior to Day 1\n16. Does not meet the radiologic anatomic inclusion criteria: i) has a primary communication with the rectum and not the anal canal; ii) is classified as a Parks extrasphincteric fistula\n17. Does not meet the minimum thresholds for the radiologic imaging endpoint inclusion criteria: i) has a MAGNIFI-CD score of \\\u003C7 (range 0-6) on screening pelvic MRI; ii) has a fibrosis-to-fluid ratio of 80% or more (range 80-100%) on screening pelvic MRI",{"count":20,"type":21},[24],"This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.",[52],"Perianal Fistula Due to Crohn's Disease","RECRUITING","2026-05-14",{"date":56,"type":32},"2026-05-15",{"date":58,"type":32},"2025-05-19",{"date":60,"type":21},"2027-12-31",{"name":38,"class":39},5,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":88,"locationsCount":89},"100466469","phase-3-extracellular-vesicle-treatment-for-acute-respiratory-distress-syndrome-ards-extinguish-ards-100466469","NCT05354141","Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)","Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients With Moderate-to-Severe ARDS: A Phase III Clinical Trial","Inclusion Criteria:\n\n1. Men and women aged 18-75 years of age\n2. Presence of the following criteria for moderate to severe ARDS as defined by the Berlin Criteria within 24 hours of the first infustion:\n\n   1. Onset within 7 days of known clinical insult or requiring increasing respiratory rate, increasing oxygen flows, or increased work of breathing, and\n   2. Bilateral lung opacities not fully explained by pleural effusions, atelectasis, or nodules, and\n   3. PaO2\u002FFiO2 (P\u002FF ratio) ≤ 200 mm Hg, and\n   4. Invasive or noninvasive ventilation with a minimum PEEP 5 cm H2O or minimum of continuous positive airway pressure (CPAP) 5 cm H2O, or High Flow Nasal Oxygen at ≥ 30 L\u002Fmin, and\n   5. Respiratory failure not fully explained by cardiac failure or fluid overload.\n\nExclusion Criteria:\n\n1. Lack of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).\n2. Stated unwillingness to comply with all study procedures and availability for the duration of the study\n3. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.\n4. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.\n5. Major physical trauma in the last 2 days, including motor vehicle accidents, assaults, mechanical falls with sequelae of significant bleeding or craniofacial bruising, and surgeries, such that not one or more injury may be undiagnosed at time of screening.\n6. Duration of mechanical ventilation exceeds 3 days or 72 hours from diagnosis of ARDS.\n7. ALT or AST \\> 8 x Upper Limit of Normal (ULN).\n8. Documented history of cirrhosis.\n9. DNR order, as in electing not to receive chest compressions, cardiac defibrillation, cardiac drugs, or intubation.\n10. Moribund-expected survival \\\u003C 24 hours.\n11. Severe metabolic disturbances at randomization (e.g., ketoacidosis, pH \\\u003C 7.2)\n12. Patient currently connected to Extracorporeal Membrane Oxygenation at initiation of screening.\n13. If the candidate, either a male or female of reproductive potential, is unwilling to two methods of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The required duration of usage of double method OR maintenance of abstinence must include the time from the beginning of the screening period until Day 61, day of withdrawal or early termination\n14. Use of investigational COVID-19 agents or any other investigational agents within 30 days prior to the first dose.",{"count":71,"type":21},970,[73],"PHASE3","To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).",[76,77],"Acute Respiratory Distress Syndrome","ARDS",[79,80,81,77],"ExoFlo","Extracellular Vesicles","Exosome","2026-02-20",{"date":84,"type":32},"2026-02-23",{"date":86,"type":32},"2022-07-01",{"date":60,"type":21},{"name":38,"class":39},32,""]