[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PharmaBio Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100594207","clinical-study-of-pal-222-targeting-patients-with-refractory-skin-ulcer-100594207",false,"NCT07016438","Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer","Phase I\u002FIIa Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer","Inclusion Criteria:\n\n* (1) Patients aged 20 years or older at the time of obtaining consent (2) Patients with skin ulcers whose ulcer size has decreased by less than 50% compared to before the start of treatment even after 4 weeks or more of conservative standard treatment (3) Patients with an ulcer of 1 cm2 or more and 3 cm2 or less after debridement (4) Patients with ulcers within 5 cm from the ulcer to be treated (5) Patients with no signs of local infection in the ulcer to be treated (6) If the ulcer had the bone exposure, it needs to be within 10% of the ulcer area (7) Patients with skin reflux pressure of 30 mmHg or more at the treatment site (if the patient has an ulcer on the lower leg or foot) (8) Patients who have received a written explanation of this clinical trial from the principal investigator or clinical investigator, fully understood the information, and given their own written consent to participate in this clinical trial (9) Patients who are able to follow oral or written instructions from the principal investigator or clinical investigator\n\nExclusion Criteria:\n\n* (1) Patients with any of the following systemic diseases\n\n  1. Poorly controlled diabetes mellitus (HbA1c greater than 10% at the most recent examination within 28 days prior to enrollment)\n  2. Hypoalbuminemia (serum albumin level less than 2 g\u002FdL)\n  3. Patients requiring continuous oral steroids (prednisolone equivalent greater than 10 mg per day) (2) Patients requiring general anesthesia or lumbar anesthesia during the study period for the following reasons\n\n  \u003C!-- -->\n\n  1. When local anesthesia is not appropriate for debridement due to scarring or hardness of the wound\n  2. Patients who are mentally disturbed, have involuntary movements, or are unable to keep the wound at rest during transplantation (3) Patients with a history of allergy to human serum albumin, trypsin, anesthetics used in this study, antiseptics, or covering materials (4) Patients with abnormal findings on hematology, hematochemistry, coagulation, or urinalysis at the time of screening that would be problematic for participation in the clinical trial (5) Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or syphilis serology at screening (6) Patients with severe blood disorders (if any of the following criteria are met)\n\n  \u003C!-- -->\n\n  1. Hemoglobin less than 10.0 g\u002FdL\n  2. White blood cell count less than 3,000 \u002Fmicroliter\n  3. Neutrophil count less than 1,500 \u002F microliter\n  4. Platelet count less than 75,000 \u002F microliter (7) Patients with severe heart failure (NYHA cardiac function classification III-IV) (8) Patients with severe hepatic impairment (with a history of or complicated by fulminant hepatitis, cirrhosis, liver tumor, or any of the following criteria)\n\n  \u003C!-- -->\n\n  1. Total bilirubin 1.5x (upper limit of reference value) or higher\n  2. AST (GOP) 3.0x (upper limit of reference value) or more\n  3. ALT (GPT) 3.0x (upper limit of reference value) or more\n  4. ALP 2.5x (upper limit of reference value) or higher (9) Patients with severe renal impairment (creatinine greater than 2 mg\u002FdL) (10) Patients diagnosed with or requiring treatment for malignancy within 5 years prior to obtaining consent (11) Pregnant or lactating women, or patients who wish to become pregnant during the study period (12) Patients whose anticoagulant or antiplatelet medication cannot be discontinued prior to the clinical trial, as determined by the attending physician of the relevant department (13) Patients with drug addiction or alcoholism (14) Patients who are currently participating in another clinical trial (15) Patients who have participated in this clinical trial once and had PAL-222 implanted (16) Patients who are judged to be inappropriate as subjects by the investigator or subinvestigator","ALL","20 Years",{"count":19,"type":20},6,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to assess safety and efficacy in patients with with Refractory skin ulcer no response to existing therapy.\n\nThe main measures it aims to answer are:\n\n* Investigation of adverse events\n* Changes in clinical testing data\n* Changes in vital signs Participants will have one PAL-222 transplanted to the ulcer site. Researchers will compare before and after the transplantation to see if any safety issues are recognized.",[26],"Refractory Skin Ulcer","RECRUITING","2025-06-04",{"date":30,"type":31},"2025-06-11","ACTUAL",{"date":33,"type":31},"2025-04-15",{"date":35,"type":20},"2025-12-31",{"name":37,"class":38},"PharmaBio Corporation","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":39},"100593352","progression-suppression-and-retinal-regression-in-vegf-resistant-amd-100593352","NCT07005323","Progression Suppression and Retinal Regression in VEGF-resistant AMD","Phase I\u002FIIa Clinical Study of PAL-222 Targeting Patients With Neovascular Age-related Macular Degeneration (AMD) That Shows no Response to Existing Therapy","PRESERVE","Inclusion Criteria:\n\n1. Patients aged between 50 and 85 years at the time of consent acquisition\n2. Patients diagnosed neovascular AMD in one or both eyes\n3. Patients with corrected letter vision in the subject eye of 20 letters or more (equivalent to decimal vision of 0.05) and less than 60 letters (equivalent to decimal vision of 0.32)\n4. Patients who apply to one or more of the followings:\n\n   ① RPE defect site in the RPE tear includes the Fovea\n\n   ② The Macular atrophy confirmed by low fundus autofluorescence extends to the fovea\n\n   ③ Patients with choroidal thinning (150 micrometer and less), subretinal fluid resistant to standard treatment, and high activity, but without hard exudated or subretinal hemorrhage which are indicators of the high risk of visual impairment.\n\n   ④ Patients with cystoid macular degeneration with photoreceptor cell loss and intraretinal fluid above fibrovascular pigment epithelial detachment, but without hard exudates or subretinal hemorrhage.\n5. Patients who had little improvement in exudative changes and no improvement, or deterioration of vision in recent two treatment with VEGF inhibitor therapy (two consecutive administration at 4-8-week intervals), after existing therapy\n\nExclusion Criteria:\n\n1. Patients with fibrovascular pigment epithelial detachment (thickness 50 µm or more) in the subfoveal area in the subject eye.\n2. Patients with hard exudates in the subretinal or intraretinal area in the subject eye.\n3. Patients with eye infections\n4. Patients with a history of retinal vascular disease other than neovascular AMD, retinal degenerative disease, rhegmatogenous retinal detachment, macular hole, premacular membrane with retinal wall, uveitis, or other ocular inflammatory disease in the subject eye.\n5. Patients with optic nerve atrophy in the subject eye\n6. Patients with progressive glaucoma in the subject eye (in whom intraocular pressure is not controlled, or visual field loss is progressive or has already spread to the macula)\n7. Patients with severe myopia in the subject eye (axial length of 26.5 mm or more, or spherical equivalent of -7.0 D or less in phakic eyes)\n8. Patients who have undergone intraocular surgery in the subject eye. (In the case of cataract surgery, patients may be enrolled if they have had no endophthalmitis or other complications, have progressed well, and more than 3 months have passed since the surgery)\n9. Patients with corrected visual acuity of the non-subject eye 0.1 or less\n10. Patients who are currently receiving or will receive VEGF inhibitor treatment in the non-subject eye during the study period\n11. Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.\n12. Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction\n13. Patients with allergies to human serum albumin antibiotics, trypsin\n14. Patients with severe blood disorders, heart failure, liver disorders, and renal disorders\n15. Patients diagnosed with malignant tumor within 5 years or patients requiring treatment\n16. Pregnant women, lactating women, patients wishing to become pregnant during the trial period\n17. Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial\n18. Patients with drug addiction or alcoholism","50 Years","85 Years",{"count":51,"type":20},10,[23],"The goal of this clinical trial is to assess safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy.\n\nThe main measures it aims to answer are:\n\n* Investigation of adverse events\n* Changes in clinical testing data\n* Changes in vital signs\n* Changes in intraocular pressure of the therapeutic eye\n* Changes in testing of anterior segment of the therapeutic eye Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.\n\nResearchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized",[55],"Neovascular Age-related Macular Degeneration (AMD)","2025-06-02",{"date":58,"type":31},"2025-06-05",{"date":60,"type":31},"2024-09-12",{"date":62,"type":20},"2027-03",{"name":37,"class":38},""]