[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cellution Biologics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100633685","phase-4-evaluate-the-efficacy-and-safety-of-amnion-membrane-disc-allograft-vs-standard-of-care-in-participants-with-dry-eye-disease-100633685",false,"NCT07529899","Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft vs Standard of Care in Participants With Dry Eye Disease","A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease","BLINK","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Corneal Fluorescein Staining (CFS) Modified NEI grade \\&gt; 15 in the study eye.\n3. Distance best corrected visual acuity better than 20\u002F60 Snellen equivalent in each eye\n4. Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.\n5. Participant must be able to follow study instructions, with the intention of completing all required visits\n6. Participant must agree to attend the study visits required by the protocol.\n7. Participant must be able and willing to complete follow-up.\n8. Participant must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. Presence of persistent corneal epithelial defect or ulcer in either eye\n2. Presence of active ocular infection in either eye\n3. Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis\n4. Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis\n5. Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)\n6. Contact lens wear\n7. History of recent ocular surgery\u002Ftrauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK\n8. Presence of cicatricial ocular surface diseases\n9. History of procedures listed in 6.7.1 within the specified washout period\n\n   CONFIDENTIAL\n\n   Version No. 1 Version Date 06APR2026\n\n   Page PAGE 67 of NUMPAGES 67\n\n   VERSION 1.0 CELLUTION BIOLOGICS INC. 06 APRIL 2026\n10. History or use of any medications listed in 6.7.2 within the specified washout period\n11. Ophthalmic use of amniotic membrane in the past 90 days.\n12. Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and\u002For are unwilling to utilize an appropriate form of contraception.\n13. Medical or psychological condition that, in the opinion of the investigator, may interfere with study.\n14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.",[27],"Dry Eye Disease (DED)",[29],"Dry Eye","NOT_YET_RECRUITING","2026-08-04",{"date":33,"type":34},"2026-08-06","ACTUAL",{"date":36,"type":21},"2026-09",{"date":38,"type":21},"2027-12",{"name":40,"class":41},"Cellution Biologics","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":4},"100630583","phase-4-evaluation-of-safety-and-efficacy-of-dehydrated-human-amnion-intermediate-chorion-membrane-dhaicm-allograft-in-treatment-of-partial-thickness-thermal-burns-100630583","NCT07489560","Evaluation of Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft in Treatment of Partial Thickness Thermal Burns","A Prospective, Multicenter, Randomized, Controlled Clinical Investigation Evaluating the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns","PHOENIX","Inclusion Criteria:\n\n* 18 years of age or older\n* One or more thermal burns classified as either superficial partial thickness or deep partial thickness.\n* Total Body Surface Area (TBSA) involvement between 5% and 15%.\n* Total burn index wound area is greater than 25 cm 2 and less than 0.25 m 2 (2500 cm 2 )\n* 1 If 2 or more burns are present, each must have an area greater than 15 cm 2\n* The participant must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n* Full thickness burns.\n* Burns present for \\&gt;72 hours prior to study evaluation\n* Burns requiring immediate autografting.\n* Superficial burns (1 st -degree) or burns not meeting criteria to be included in TBSA calculations.\n* Chemical or electrical burns.\n* Burns secondary to blast injury.\n* Burns causing vascular or respiratory compromise and burns requiring escharotomy\n* Any severe systemic comorbidities which could impair healing (e.g. active sepsis or major organ failure).\n* Known coagulopathy, platelet disorder, INR \\&gt; 1.6, PTT \\&gt; 38s, or platelets \\&lt; 50,000 per mm 3\n* Uncontrolled diabetes.\n* Known life expectancy of \\&lt; 6 months.\n* Evidence of active infection in burn.\n* Target area for treatment includes the head, neck, palms of hands, soles of the feet, or genitals.\n* Viral infection which could impair healing or immune function (e.g. HIV, HBV, HCV)\n* Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and\u002For are unwilling to utilize an appropriate form of contraception.\n* Currently requiring dialysis or planning to start within 6 months.\n* Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.\n* Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.\n* Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n* Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.",{"count":51,"type":21},70,[24],"This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn ™ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT\u002FPs), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.",[55],"Partial Thickness Burn",[57,58],"thermal burn","burn",{"date":33,"type":34},{"date":61,"type":21},"2026-10",{"date":38,"type":21},{"name":40,"class":41},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":4},"100621787","evaluation-of-the-safety-and-efficacy-of-dehydrated-human-placenta-tissue-dhpt-for-wound-healing-100621787","NCT07375160","Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","A Retrospective, Real World Evidence (RWE) Trial to Evaluate the Safety and Efficacy of a Dehydrated Human Placenta Tissue (dHPT) for Wound Healing","RETRO-PLAST","Inclusion Criteria:\n\n* 18 years of age or older.\n* Wound treated with Cellution Biologics AmchoPlast, a dehydrated human placental tissue (dHPT).\n* Wound present for greater than or equal to 30 days prior to treatment with dHPT.\n* Wound is not infected.\n* Wound surface area is greater than 1cm2 at initial assessment.\n* Clinical documentation of wound treatment.\n\nExclusion Criteria:\n\n* AmchoPlast dHPT product was not applied to wound.\n* HbA1C \\>12%.\n* Presence of active osteomyelitis.\n* Concurrent treatment for malignant disease.\n* Use of other advanced biologics during treatment period.",{"count":73,"type":21},300,"OBSERVATIONAL","The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.",[77,78,79],"Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Pressure Ulcer (PU)",[81,82,83,84,85],"Chronic Wound","Leg Wound","Amniotic","Allograft","Placenta","2026-02-27",{"date":88,"type":34},"2026-03-03",{"date":90,"type":21},"2026-04",{"date":92,"type":21},"2026-12",{"name":40,"class":41},""]