[{"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:":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,96,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100633685","phase-3-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-100633685",false,"NCT07529899","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 \\> 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":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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.",[26],"Dry Eye Disease (DED)",[28],"Dry Eye","NOT_YET_RECRUITING","2026-04-08",{"date":32,"type":33},"2026-04-14","ACTUAL",{"date":35,"type":20},"2026-07",{"date":37,"type":20},"2026-12",{"name":39,"class":40},"Cellution Biologics","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100630583","phase-4-evaluation-of-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-100630583","NCT07489560","Evaluation of 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","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 \\>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 \\> 1.6, PTT \\> 38s, or platelets \\< 50,000 per mm 3\n* Uncontrolled diabetes.\n* Known life expectancy of \\< 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":50,"type":20},70,[52],"PHASE4","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","2026-03-18",{"date":61,"type":33},"2026-03-24",{"date":63,"type":20},"2026-06",{"date":65,"type":20},"2027-06",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":95,"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":76,"type":20},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.",[80,81,82],"Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Pressure Ulcer (PU)",[84,85,86,87,88],"Chronic Wound","Leg Wound","Amniotic","Allograft","Placenta","2026-02-27",{"date":91,"type":33},"2026-03-03",{"date":93,"type":20},"2026-04",{"date":37,"type":20},{"name":39,"class":40},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100610650","phase-4-nonhealing-venous-leg-ulcers-treated-with-a-standard-of-care-soc-alone-or-standard-of-care-and-dehydrated-human-placenta-tissue-dhpt-with-crossover-100610650","NCT07230340","Nonhealing Venous Leg Ulcers Treated With a Standard of Care (SoC) Alone or Standard of Care and Dehydrated Human Placenta Tissue (dHPT) With Crossover","A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers With Crossover for Subjects Randomized to Standard of Care","EVOLVE","Inclusion Criteria:\n\nParticipants are required to meet all the following criteria for enrollment into the study:\n\n1. 18 years of age or older.\n2. Hemoglobin A1c (HbA1c) level is \\\u003C12% (108 mmol\u002Fmol).\n3. Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.\n4. Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.\n5. Affected limb must have adequate perfusion confirmed by vascular assessment performed within 90 days of screening visit. Any of the following methods are acceptable:\n\n   1. ABI ≥ 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic or triphasic.\n6. If the participant has two or more ulcers, they must be separated by at least 2 cm post debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n7. The participant must agree to attend the weekly study visits required by the protocol.\n8. The participant must be willing and able to participate in the informed consent process\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from enrollment:\n\n1. Known life expectancy of \\\u003C6 months.\n2. Target ulcer is infected or there is cellulitis in the surrounding skin.\n3. Evidence of osteomyelitis complicating the target ulcer.\n4. Participant requires systemic antibiotic therapy or has used within the last 7 days.\n5. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent), receiving cytotoxic chemotherapy, or taking medications that the investigator believes will interfere with wound healing (e.g., biologics).\n6. Topical application of steroids to the ulcer surface within 30 days of screening.\n7. Target ulcer exposes tendon or bone.\n8. Surface area of the target ulcer decreases by more than 20% during the 2-week screening phase.\n9. Mini Nutritional Assessment (MNA) score of less than 17.\n10. Participants of child bearing potential who are pregnant, considering becoming pregnant within the next 6 months, and\u002For are unwilling to utilize an appropriate form of contraception.\n11. Currently requiring dialysis or planning to start within 6 months.\n12. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.\n13. Treated with hyperbaric oxygen therapy or a skin substitute within the 30 days prior to screening visit.\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.",{"count":50,"type":20},[52],"The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.",[81],[109,110,85,111,86,88,112],"VLU","Venous Ulcer","Venous Leg Ulcers (VLUs)","allograft","2025-12-09",{"date":115,"type":33},"2025-12-16",{"date":117,"type":20},"2026-01",{"date":119,"type":20},"2027-12",{"name":39,"class":40},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100594033","phase-4-nonhealing-diabetic-foot-ulcers-treated-with-standard-of-care-soc-alone-or-standard-of-care-and-amnion-intermediate-chorion-aic-100594033","NCT07014176","Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)","A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers","ELITE","Inclusion Criteria:\n\nSubjects will be eligible to participate in the study if the following conditions exist:\n\nInclusion Criteria:\n\n1. 18 years of age or older.\n2. Diagnosis of type 1 or 2 Diabetes mellitus.\n3. Hemoglobin A1c (HbA1c) level is \\\u003C 12% (108 mmol\u002Fmol).\n4. Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.\n5. Target ulcer present for minimum of 4 weeks prior to screening visit.\n6. Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.\n7. Target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n8. Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:\n\n   1. ABI ≥ 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic or triphasic.\n9. Subject with two or more ulcers must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n10. Subject must consent to using the prescribed off-loading method for the duration of the study.\n11. Subject must agree to attend study visits required by the protocol.\n12. Subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\nSubjects will be excluded from participation in the study if any of the following conditions exist:\n\n1. Known life expectancy of \\\u003C 6 months.\n2. Target ulcer is not secondary to diabetes.\n3. Target ulcer is infected or there is cellulitis in the surrounding skin.\n4. Evidence of osteomyelitis complicating the target ulcer.\n5. Infection in the target ulcer or a location that requires systemic antibiotic therapy.\n6. Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.\n7. Topical application of steroids to the ulcer surface within one month of screening.\n8. Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.\n9. Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit (\"historical\" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).\n10. Mini Nutritional Assessment (MNA) score of less than 17.\n11. Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.\n12. Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.\n13. Currently require dialysis or planning to start dialysis.\n14. Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.\n15. Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.\n16. Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.",{"count":130,"type":20},120,[52],"The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.",[134],"Diabetic Foot Ulcer",[136,137,138,134,88],"DFU","Diabetic Ulcer","Foot Wound","RECRUITING","2025-10-20",{"date":142,"type":33},"2025-10-21",{"date":144,"type":33},"2025-07-03",{"date":146,"type":20},"2026-10-31",{"name":39,"class":40},8,""]