[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"S.Biomedics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100425304","phase-1-a-study-on-the-anti-wrinkle-efficacy-assessment-and-safety-evaluation-of-the-cluster-of-autologous-dermal-fibroblast-on-bilateral-crows-feet-100425304",false,"NCT04818203","A Study on the Anti-Wrinkle Efficacy Assessment and Safety Evaluation of the Cluster of Autologous Dermal Fibroblast on Bilateral Crow's Feet","A Single Center, Randomized, Evaluator and Subject Blind, Placebo Controlled, Parallel, Phase 1\u002F2 Study for the Anti-wrinkle Efficacy Assessment and Safety Evaluation by Treating Cluster of Autologous Dermal Fibroblasts, 3D-F in Patients With Bilateral Crow's Feet","Inclusion Criteria:\n\n* Participants of ages 19 and older\n* Those with at least 3 points (Moderate) of the IGA-LCL severity scale on both sides in the rest state during screening\n* Those who have visually symmetrical periorbital wrinkles on both sides and have the same IGA-LCL severity scale score in the rest state\n* Those who agreed to discontinue all dermatological treatments including facial wrinkle improvement during this study period\n* Subjects with healthy and undamaged skin at the sampling area (e.g., behind the ears, inside of the arms, armpits, groin, etc.)\n* Those who meet the following criteria based on the blood test at screening or baseline visits\n\n  * White Blood Cell : ≥4.5x10\\^3\u002Fμl and ≤11.0x10\\^3\u002Fμl\n  * Platelet count : ≥100x10\\^3\u002Fμl\n  * Hemoglobin : ≥9 g\u002FdL\n* Those who sign the written consent form after hearing the explanation of the purpose, method, and efficacy of this study\n* Those who can be followed up during the study period\n\nExclusion Criteria:\n\n* Those with arterial bleeding or severe variceal bleeding in the body\n* Those with hypersensitivity to bovine protein or gentamicin\n* Pregnant and breast-feeding or who planning to conceive within six months of clinical trial medication\n* Out of who are pregnant or breast-feeding and A woman who is likely to be pregnant in a postmenopausal or a state of non-Infertility surgery and men with reproductive abilities not willing or planning to use the appropriate contraception defined in this clinical trial during their participation in clinical trials\n* Those with or suspected of having autoimmune diseases (e.g., myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, etc.)\n* At the screening visit, patients with chronic skin disease or such a medical history\n* Those with a medical history or a positive test result for any of the following: hepatitis C virus antibody (HCV Ab), hepatitis B surface antigen (HBsAg), human immunodeficiency virus-1 (HIV-1) antibody, human immunodeficiency virus-2 (HIV-2) antibody (However, if HCV is proven to be completely cured based on the HCV RNA test, he\u002Fshe can be enrolled as a subject.)\n* Those with severe heart diseases (e.g., myocardial infarction, heart failure, etc.) or severe liver diseases (e.g., hepatocirrhosis, liver failure, etc.) or severe kidney diseases (e.g., renal failure, etc.)\n* Those who have tumors or have such medical history within 5 years of screening (However, if the malignant tumor does not relapse for more than 5 years, the candidate may be enrolled as a subject, and in the case of basal cell carcinoma or intradermal squamous cell carcinoma that does not relapse after resection, he\u002Fshe can be enrolled as a subject.)\n* Those with genetic diseases affecting fibroblast or collagen\n* Those who have undergone anticoagulant therapy or antiplatelet therapy within 10 days prior to administration of the study drug, or those who are expected to need to receive them within 3 days after administration of the study drug (However, if the drug is being administered at the time of screening, it is possible to participate in the clinical trial after a seven-day not administering medication period only if the temporary suspension does not pose a medical risk under the tester's judgment, tried tissue biopsy Schedule.)\n* Those who have active or infectious skin diseases (skin infection, inflammation, herpes, etc.), keloids, unhealed wounds or scars, tumors, etc. at the site where the study drug will be administered, or those who have previously received radiation treatment\n* Those with hypersensitivity to local anesthetics (however, those who agree to receive the procedure without applying an anesthetic agent due to hypersensitivity to local anesthetics, do not fall under this criteria.)\n* A person who has a history of significant adverse or hypersensitive reactions to the composition of medications for clinical trials\n* Those who have undergone procedures that can affect periorbital wrinkles, such as dermabrasion, skin regeneration, and plastic surgery, etc, among facial procedures including the eye area\\* or those who are expected to have such procedures during the study period\n* Those who participated in another study and received an investigational drug or used an investigational medical device within 6 months prior to participation in this study, or those who are scheduled to participate in another study during this study period\n* Those with a medical history of autologous dermal fibroblast treatment\n* Those with a medical history of anaphylaxis or severe complex allergies\n* Those with a medical history of keloid formation, hyperpigmentation, or hypertrophic scars on the face\n* Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, or central nervous system, or have had or currently have a mental disorder that significantly affects this study\n* Those who received systemic corticosteroid within 12 weeks prior to participation in this study\n* Those who refuse to take pictures of the site where the study drug is administered\n* Those who are judged to be ineligible by the investigator to participate in this study for other reasons","ALL","19 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is a phase 1\u002F2 clinical trial to evaluate the safety and efficacy of administering clusters of autologous dermal fibroblasts to subjects with periorbital wrinkles on both sides.\n\nIf subjects who have signed the Informed consent form voluntarily are enrolled in this study, they will be tested for eligibility during the screening period. Subjects will visit the study site a total of 6 times while participating in this study. The subjects who meet the inclusion\u002Fexclusion criteria will receive a total of one dose of the IP (Visit 3). Then, the efficacy evaluation will be conducted at Visit 4 (Week 2), Visit 5 (Week 12), and Visit 6 (Week 24), and safety will also be evaluated at each visit.",[27],"Crow's Feet",[29,30,31,32,33],"Fibroblast","Anti-Wrinkle","Cell therapy","Cell spheroid","S.Biomedics","RECRUITING","2025-05-14",{"date":37,"type":38},"2025-05-18","ACTUAL",{"date":40,"type":38},"2020-07-20",{"date":42,"type":20},"2026-06-30",{"name":44,"class":45},"S.Biomedics Co., Ltd.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100424863","phase-1-safety-and-exploratory-efficacy-of-transplantation-therapy-using-psa-ncam-npc-in-ais-a-level-of-sub-acute-sci-100424863","NCT04812431","Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC in AIS-A Level of Sub-acute SCI","A Single Center, Open Label, Single Group, Phase 1\u002F2a Clinical Study to Evaluate the Safety and Exploratory Efficacy of Transplantation Therapy Using PSA-NCAM(+) NPC Derived From hESC Line in AIS-A Level of Sub-acute SCI(From 7 to 60 Days)","SB-SCI-001","Inclusion Criteria:\n\n1. Upon written consent of the patient or the legally acceptable representative of the patient\n2. Male and female patients 18 to 65 years of age\n3. Female patients who showed negative results on the pregnancy test, use an acceptable contraceptive or have no possibility of pregnancy (at least 2 years have elapsed after menopause or have undergone hysterectomy, ovariectomy, or sterilization operation), or male patients who have received vasectomy or are willing to use contraceptives for up to 90 days after administration of the investigational product using a dual contraceptive method\\*\n\n   \\*Dual contraceptive method: Method of using multiple contraceptives, such as using a cervical cap or contraceptive diaphragm in addition to a condom for males\n4. Patients who are capable of being administered with the investigational product on Day 7 to 60 after spinal cord injury\n5. Patients who have been confirmed to have spinal cord injury classified as AIS-A on ISNCSCI, SCIM and\u002For MRI by the investigator, physiatrist, or other spinal cord injury specialist\n6. Patients whose ASIA Impairment Scale (AIS) satisfies AIS-A criteria (spinal segment within C4-C7, complete injury)\n\nExclusion Criteria:\n\n1. Patients with spinal cord injury caused by penetrating trauma such as gunshot or stab wounds\n2. Patients with complete transection on the spinal cord\n3. Patients with spinal cord injury that require more than the mono-segment treatment\n4. Patients with other complications, including neurological defects related to peripheral nerve injury (neuromuscular injury or central spinal cord syndrome), or etiological causes of paraplegia or sensorimotor defects related to an additional underlying condition\n5. Patients with multiple lesions or lesions longer than 2 cm in length found on MRI examination\n6. Patients administered with cells excluding blood transfusion before participating in the clinical study\n7. Patients with the following intercurrent diseases or conditions:\n\n   1. Coagulopathy with INR\\> 1.4 at the time of administration of the investigational product (Day 0)\n   2. Active infection\n   3. Active hypotension requiring vasoconstrictor treatment (less than 60 mmHg of diastolic blood pressure)\n   4. Rupture of the skin on the area of surgery\n   5. Medical history of malignant tumor\n   6. Primary or secondary immunodeficiency\n   7. Clinically significant abnormal values discovered as a result of laboratory tests\n\n      * Creatinine \\> 1.5 mg\u002FdL\n      * When the level found in the liver-function examination is more than twice the upper limit of the normal level\n      * Hematocrit\u002Fhemoglobin \\\u003C30%\u002F10 g\u002FdL\n      * Total WBC \\\u003C 1000\u002FμL\n      * Uncontrolled hypertension (systole\\> 180 mmHg or diastole\\> 100 mmHg)\n      * Uncontrolled diabetes (HbA1c\\> 8%)\n      * Evidence of GI bleeding on the stool guaiac test\n      * Positive on tuberculosis test (However, a chest X-ray may be performed if found positive on the TB test, and the patient may be enrolled upon no findings that suggest active tuberculosis on the chest X-ray.)\n      * Hepatitis B or C\n      * Human Immunodeficiency Virus (HIV)\n   8. Substance abuse or alcoholism\n   9. Unstable or untreated psychiatric disorder\n8. Patients with known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, methylprednisolone, or prednisone\n9. Patients incapable of receiving physical therapy or combination therapy\n10. Patients incapable of going under general anesthesia due to other reasons\n11. Patients judged unsuitable for participation in this clinical study by the investigator","18 Years","65 Years",{"count":58,"type":20},5,[23,24],"This study intends to evaluate the safety and exploratory efficacy of transplantation therapy using neural precursor cells (PSA-NCAM(+) NPC) derived from the human embryonic stem cell line for the treatment of paralysis and other related symptoms from sub-acute spinal cord injury.",[62,63,64],"Spinal Cord Injury, Acute","Spinal Cord Injury at C4 Level With Complete Lesion","Spinal Cord Injury at C5-C7 Level With Complete Lesion",[66,67],"Spinal cord injury","AIS-A",{"date":37,"type":38},{"date":70,"type":38},"2021-09-23",{"date":72,"type":20},"2030-09",{"name":44,"class":45},""]