KCT0009212尚未招募Unknown
Evaluate the Safety and potential efficacy of human Wharton’s jelly-derived mesenchymal stem cells (EN001) in patients with Charcot-Marie-Tooth disease type 1E)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Those who voluntarily agreed to participate in this clinical study
- •2) Men and women over 19 years of age as of the date of written consent
- •3) Those who meet all of the following genetic and clinical diagnostic criteria
- •? Genetic diagnosis: CMT1E
- •? Clinical diagnosis
- •- CMTNS score of 2 or more
- •- Those with muscle weakness due to foot dorsiflexion
- •4) Women or men of childbearing potential who agreed to use the appropriate contraceptive method suggested in the protocol during the clinical study period.
- •? Appropriate contraception is defined as follows, and is achieved by applying one or more methods of contraception.
- •- Hormonal contraceptives
- •- Implantation of an intrauterine device or intrauterine system
- •- Sterilization procedures (vasectomy, tubal ligation, etc.)
排除标准
- •1) Those with the following comorbidities confirmed at the time of screening
- •(1) Those who have a neuromuscular disease other than CMT1E or a neuropathy-causing factor (uremia) that may affect the safety and treatment effect of this clinical study, according to the judgment of the researcher.
- •(2) Those diagnosed with type 1 or type 2 diabetes
- •(3) Those diagnosed with active pulmonary tuberculosis
- •(4) Patients with uncontrolled hypertension (systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg)
- •(5) Persons with other clinically significant diseases, including significant heart, lung, liver, kidney, hematological, immunological or behavioral diseases or malignant tumors, according to the judgment of the researcher.
- •(6) Those who show the following test abnormalities in clinical laboratory tests at the time of screening
- •? AST or ALT > 3 x ULN
- •?Total bilirubin > 1.5 x ULN
- •? Serum creatinine > 1.5 x ULN
- •? D-dimer > 1.5 x ULN
- •? Serum virus test (HBsAg, anti-HBc, anti-HCV,
- •Positive for any one of HIV Ag/Ab)
- •- (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.
- •2) Medical history and surgical history
- •(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
- •(2) Those with a history of stroke or cerebral ischemic attack within 48 weeks before screening
- •(3) Those with a history of coronary artery disease, such as myocardial infarction or incomplete angina, within 48 weeks before screening
- •(4) Persons with a history of malignant tumor within 240 weeks prior to screening (excluding basal cell carcinoma or squamous cell carcinoma that occurs on the skin)
- •3) Drugs and therapies prohibited from concurrent use
- •(1) A person who participated in another clinical trial and administered/applied an investigational drug or medical device within 4 weeks before screening
- •(2) Those who administered/applied immunosuppressants, chemotherapy, radiation therapy, etc. within 12 weeks before screening
- •(3) Those who administered stem cell therapy or gene therapy within 240 weeks before screening
- •(4) Persons who have administered neurotoxic drugs that may accelerate peripheral nerve damage
- •- Platinum series: cisplatin, carboplatin, oxaliplatin
- •- Taxane series: paclitaxel, docetaxel
- •- Proteasome inhibitors: bortezomib, carfilzomib, ixazomib, etc.
- •- thalidomide and derivatives: thalidomide, lenalidomide, pomalidomide
- •- Vinca alkaloid series: vincristine, vinblastine, vindesine, vinorelbine
- •- Antiarrhythmic drug: amiodarone
- •- Anti-inflammatory and antibiotic: colchicine, nitrofurantoin
- •- Antiretroviral drugs: zalcitabine, stavudine
- •- Others: dichloroacetate, tacrolimus, suramin
- •4) Persons with hypersensitivity to the components of human cells (EN001) used in this clinical study
- •5) Those who have had metal substances (heart pacemaker, nerve stimulator, cochlear implant, etc.) implanted in their body
- •6) Pregnant, lactating, or planning to become pregnant while participating in clinical research
- •7) Persons with a psychiatric disorder (anxiety disorder, claustrophobia, or other significant mental disorder) or a histor
研究者
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