[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ENCell\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":43},"100655284","phase-1-evaluate-the-efficacy-and-safety-of-en001-in-patients-with-sarcopenia-phase-1-open-label-dose-escalation-single-center--phase2-randomized-double-blind-placebo-controlled-multi-center-100655284",false,"NCT07808905","Evaluate the Efficacy and Safety of EN001 in Patients With Sarcopenia","A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1\u002F2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients With Sarcopenia","Inclusion Criteria:\n\n* 1\\) Male or Female aged 60 years or older at the time of providing written consent. : Female subjects must meet one of the following criteria for postmenopausal women\\* :\n\n  * Postmenopausal women:\n\n    * Natural amenorrhea for 12 months\n    * At least 6 weeks after surgical menopause (bilateral oophorectomy)\n* 2\\) Individuals diagnosed with sarcopenia at the time of screening, based on the diagnostic criteria in Section 15.1 of the Asian Working Group for Sarcopenia(AWGS) 2019 guidlines, meeting (1) or (2) together with (3):\n\n  * (1) Handgrip Strength: \\\u003C 28kg(men), \\\u003C18kg(women)\n  * (2) 6-Metre Walk test\\\u003C1.0m\u002Fs, or 5-Times Chair Stand Test ≥12seconds, or Short Physical Performance Battery(SPPB)≤9points\n  * (3) Appendicular Skeletal Muscle Mass(ASM) by dual-energy X-ray absorptiometry(DXA):7.0kg\u002Fm\\^2(men), \\\u003C5.4kg\u002Fm\\^2(women)\n* 3\\) Individuals with a nutritional status score of ≥8points on the Screening component of the Long Mini Nutritional Assessment (Long MNA) at the time of screening\n* 4\\) Individuals with a body weight of ≥35 kg and a Body Mass Index (BMI) of ≥15 kg\u002Fm² and \\\u003C30 kg\u002Fm² at the time of screening\n* 5\\) Individuals who have stably adhered to the diet and exercise regimen provided as part of this clinical trial during a run-in period of at least 4 weeks, and who are willing to comply with the regimen throughout the trial period\n* 6\\) Individuals meeting the following laboratory test criteria at the time of screening and baseline:\n\n  * Hemoglobin ≥10 g\u002FdL,\n  * White Blood Cell ≥2,500\u002FμL,\n  * Platelet ≥100,000\u002FμL,\n  * AST or ALT ≤3 × ULN,\n  * International Normalized Ratio (INR) ≤1.3\n* 7\\) Men who have agreed to use the appropriate contraceptive method(s), as specified in the protocol, from the date of signing the informed consent form through the end-of-study visit\n\n  * Appropriate contraception is defined as follows and is achieved by applying one or more methods of contraception :\n\n    * Partner's use of hormonal contraceptives\n    * Partner's placement of an intrauterine device(IUD) or intrauterine system(IUS)\n    * Sterilization procedure or surgery in the participant or partner\n    * Double contraceptive method: use of a male condom in combination with other contraceptive methods \\[hormonal contraceptives, IUD\u002FIUS placement, or sterilization procedure\u002Fsurgery)\n    * Abstinence: Absolute abstinence. If, in the examiner's judgment, the subject's age, occupation, lifestyle, or sexual orientation warrants contraception, strict abstinence from sexual intercourse is also acceptable. However, periodic abstinence (e.g. Karenda method, ovulation method, symptomatic temperature method), abstinence, and external vaginal ejaculation are not recognized as appropriate contraceptive methods.\n\n      8\\) Individuals who(or whose legally authorized representative) have voluntarily agreed to participate in this clinical trial.\n\nExclusion Criteria:\n\n* 1)Those with the following comorbidities confirmed at the time of screening and baseline\n\n  * Patients with chronic kidney disease(CKD-EPI;Estimated Glomerular Filtration Rate(eGFR) \\\u003C30 mL\u002Fmin)\n  * Individuals with uncontrolled thyroid disease(hyperthyroidism or hypothyroidism)\n  * Patients with uncontrolled diabetes(HbA1c \\>8.5%)\n  * Individuals with a neuromuscular or neurological disease (e.g., Parkinson's disease, amyotrophic lateral sclerosis \\[ALS\\], stroke affecting lower extremity function, muscular dystrophy, epilepsy, multiple sclerosis, etc.)\n  * Individuals with severe cardiac disease classified as New York Heart Association (NYHA) Functional Classification III or IV (cardiomyopathy, unstable angina, myocardial infarction, valvular heart disease, arrhythmia, aortic disease, etc.)\n  * Patients with uncontrolled hypertension((Systolic Blood Pressure (SBP) \\>180 mmHg or Diastolic Blood Pressure (DBP) \\>110 mmHg)\n  * Any one of the serum virus tests (HBsAg, anti-HBc, anti-HCV, HIV Ag\u002FAb) is positive\n\n    * (If anti-HBc positive) However, registration is possible if the HBV DNA test result is negative.\n    * (If anti-HCV positive) However, registration is possible if the HCV RNA test result is negative.\n  * Any malignancy within 5 years before screening (excluding basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or carcinoma in situ of the cervix may be enrolled even if the 5-year period has not elapsed, provided the investigator determines that the condition has been successfully treated and is in complete remission)\n  * Any medical condition or history of surgery within 24 weeks prior to screening that may affect physical activity or function, including walking or exercise (e.g., fracture, severe knee or hip osteoarthritis, peripheral vascular disease)\n* 2\\) Subjects with a confirmed history of the following treatments:\n\n  * Systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday at screening\n  * Any of the following medications that may affect muscle at screening:\n\n    * Growth hormones (e.g., insulin-like growth factor-1 \\[IGF-1\\] analogues, somatropin)\n    * Sex hormones (e.g., testosterone, estrogen, dehydroepiandrosterone \\[DHEA\\])\n    * Ghrelin or megestrol acetate\n    * Myostatin or myostatin inhibitors (e.g., stamulumab, domagrozumab, landogrozumab)\n    * Bimagrumab\n    * β-receptor blockers, ACE inhibitors, TNF-α antagonists, or GLP-1 agonists (Subjects receiving any of these medications at a stable dose for ≥12 weeks prior to screening and who plan to continue the treatment throughout the study may be enrolled.)\n    * Troponin Activator\n  * Prior treatment with any cell therapy or gene therapy at any time in their lifetime\n  * Those who have received other investigational medicinal products or medical devices within 4 weeks prior to screening\n* 3\\) Subjects with a Korean version of Montreal Cognitive Assessment (MoCA-K) score of less than 23 at screening\n* 4\\) Persons with hypersensitivity to the components of clinical investigational products\n* 5\\) Those who are unable to read or write\n* 6\\) Those who are deemed inappropriate to participate in clinical trials according to the judgment of the investigator\\*\n\n  * Examples of inappropriate reasons include, but are not limited to, the following:\n\n    * History of drug or alcohol dependence or abuse\n    * Medical history (e.g., autoimmune diseases such as myositis, dystonia, etc.) or surgical history that may affect efficacy evaluations, other than those specified in the inclusion\u002Fexclusion criteria\n    * Subjects who are currently participating in, or plan to participate in, high-intensity bodybuilding, muscle-building, or muscle-strengthening programs (However, routine physical activity is not restricted.)","ALL","60 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1\u002F2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Sarcopenia",[27],"Sarcopenia",[29,27,30,31],"EN001","ENCell","MSC","NOT_YET_RECRUITING","2026-09-08",{"date":35,"type":36},"2026-09-11","ACTUAL",{"date":38,"type":20},"2027-03-01",{"date":40,"type":20},"2029-10-31",{"name":30,"class":42},"INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100541350","phase-1-evaluate-the-safety-and-efficacy-of-en001-in-patients-with-charcot-marie-tooth-disease-type-1acmt1a-phase-1b-open-label-dose-escalation-single-center-phase-2a-randomized-double-blind-placebo-controlled-multicenter-100541350","NCT06328712","Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A(CMT1A) (Phase 1b: Open-label, Dose-escalation, Single-center; Phase 2a: Randomized, Double-blind, Placebo-controlled, Multicenter)","A Phase 1b\u002F2a Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients With Charcot-Marie-Tooth Disease Type 1A(CMT1A) (Phase 1b: Open-label, Dose-escalation, Single-center; Phase 2a: Randomized, Double-blind, Placebo-controlled, Multicenter)","Inclusion Criteria:\n\n1. Individuals who have voluntarily agreed to participate in this clinical trial.\n2. Men and women aged 19 years or older at the time of providing written consent.\n3. Individuals who meet all of the following genetic and clinical diagnostic criteria:\n\n   1. Genetic diagnosis: CMT1A type\n   2. Clinical diagnosis:\n\n      * Those with a CMT Neuropathy Score version 2 (CMTNSv2) between 2 or more and 20 or less.\n      * Those experiencing muscle weakness due to foot dorsiflexion impairment.\n4. Women and men of childbearing potential who have agreed to use the appropriate contraceptive method(s) outlined in the protocol during the clinical trial period.\n\n   * Appropriate contraception is defined as follows and is achieved by applying one or more methods of contraception.\n\n     * Hormonal contraceptives\n     * Implantation of an intrauterine device or intrauterine system\n     * Sterilization procedures (vasectomy, tubal ligation, etc.)\n     * Double contraceptive method: male condom along with other contraceptive methods \\[hormonal contraceptives (oral contraceptives, subcutaneous contraceptives (Implanon, etc.), long-acting contraceptive injections, emergency contraceptive pills), implantation of an intrauterine device or intrauterine system (Loop, Mirena), Infertility procedures (vasectomy, tubal ligation, etc.)\\]\n     * Abstinence: Absolute abstinence. If, in the examiner's judgment, the subject's age, occupation, lifestyle, or sexual orientation warrants contraception, strict abstinence from sexual intercourse is also acceptable. However, periodic abstinence (e.g. Karenda method, ovulation method, symptomatic temperature method), abstinence, and external vaginal ejaculation are not recognized as appropriate contraceptive methods.\n\nExclusion Criteria:\n\n1. Those with the following comorbidities confirmed at the time of screening\n\n   1. Subjects with neuromuscular diseases other than CMT1A or neuropathy- inducing factors (uremia) that may affect the safety and efficacy evaluation of this clinical trial, according to the judgment of the investigator.\n   2. Individuals diagnosed with type 1 or type 2 diabetes\n   3. Individuals diagnosed with active pulmonary tuberculosis\n   4. Patients with uncontrolled hypertension (systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg)\n   5. Subjects with other clinically significant diseases, including significant heart, lung, liver, kidney, hematological, immunological or behavioral diseases or malignant tumors, according to the investigator's judgment\n   6. Individuals who display the specified test abnormalities in laboratory tests at the time of screening:\n\n      * AST or ALT \\> 3 x ULN\n      * Total bilirubin\\> 1.5 x ULN\n      * Serum creatinine \\> 1.5 x ULN\n      * Any one of the serum virus tests (HBsAg, anti-HBc, anti-HCV, HIV Ag\u002FAb) is positive (If anti-HBc positive) However, registration is possible if the HBV DNA test result is negative. (If anti-HCV positive) However, registration is possible if the HCV RNA test result is negative.\n   7. Those who have ankle contracture or have undergone surgery that may affect muscle strength measurement tests\n2. Medical history and surgical history\n\n   1. Those who have undergone orthopedic surgery (bone or ligament correction, artificial joint implantation, osteotomy, arthroscopic surgery) on the lower extremities within 24 weeks before screening\n   2. Those with a history of stroke or cerebral ischemic attack within 48 weeks before screening\n   3. Those with a history of coronary artery disease, such as myocardial infarction or incomplete angina, within 48 weeks before screening\n   4. Those with a history of malignant tumor within 240 weeks before screening (excluding basal cell carcinoma or squamous cell carcinoma that occurs on the skin)\n3. Drugs and therapies prohibited from concurrent use\n\n   1. Those who participated in another clinical trial and administered\u002Fapplied clinical trial drugs\u002Fmedical devices within 4 weeks before screening\n   2. Those who administered\u002Fapplied immunosuppressants, chemotherapy, radiation therapy, etc. within 12 weeks before screening\n   3. Persons who have administered cell therapy or gene therapy throughout their lives\n   4. Persons who have administered neurotoxic drugs that can accelerate peripheral nerve damage ① Within 1 week of Screening\n\n      * Anti-inflammatory agents or antibiotics: Colchicine, Nitrofurantoin\n      * Antiretroviral agents: Zalcitabine, Stavudine\n      * Dichloroacetate\n\n        ② Within 55 weeks of Screening\n      * Antiarrhythmic agent: Amiodarone\n      * Antiparasitic agent: Suramin\n4. Persons with hypersensitivity to the components of clinical investigational products\n5. Those who have had metal substances (heart pacemaker, nerve stimulator, cochlear implant, etc.) implanted in their body\n6. Pregnant, lactating, or planning to become pregnant during the clinical trial period\n7. Subjects with a psychiatric disorder (anxiety disorder, claustrophobia, or other significant mental disorder) or a history of drug and alcohol abuse that may affect the clinical trial, according to the judgment of the investigator.\n8. Those who are deemed inappropriate to participate in clinical trials according to the judgment of the investigator","19 Years",{"count":53,"type":20},27,[23,24],"A Phase 1b\u002F2a Clinical Trial to Evaluate the Safety and Efficacy of EN001 in Patients with Charcot-Marie-Tooth Disease type 1A(CMT1A) (Phase 1b: Open-label, Dose-escalation, Single-center; Phase 2a: Randomized, Double-blind, Placebo-controlled, Multicenter)",[57],"Charcot-Marie-Tooth Disease Type 1A",[29,59,30,31,60],"CMT1A","CMT","RECRUITING","2026-05-21",{"date":64,"type":36},"2026-05-26",{"date":66,"type":36},"2024-05-30",{"date":68,"type":20},"2026-12-31",{"name":30,"class":42},3,""]