JPRN-jRCT2033230295招募中1 期
A multicenter, uncontrolled, open-label study to investigate the safety and the efficacy of human (allogeneic) amnion-derived mesenchymal stem cells KA-301 for Duchenne muscular dystrophy
akaishi Tomoyuki0 个研究点目标入组 18 人开始时间: 2023年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- >= 5age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients diagnosed with Duchenne muscular dystrophy based on medical history and genetic diagnosis
- •(2) Patients who can walk independently without using walking aids
- •(3) Patients who can complete getting up from the floor in less than 10 seconds
- •(4) Patients who have been receiving corticosteroids for the treatment of the primary disease at a certain dose for at least 3 months prior to the start of administration of the investigational product and are expected to receive the same dose throughout the study period
- •(5) Patients aged at least 5 years old at the time of consent
- •(6) Patients for whom written consent is obtained from a legally acceptable representative (guardian) (Whenever possible, written consent is also obtained from the patient)
排除标准
- •(1) Patients who cannot assess motor function due to cognitive impairment or behavioral problems
- •(2) Patients with injuries that may affect the assessment of motor function, except for patients whose previous lower extremity fractures have completely healed and at least 3 months have passed from the date of injury
- •(3) Patients with complication or history of chronic systemic fungal or viral infection
- •(4) Patients with acute illness within 4 weeks prior to the first administration of the investigational product
- •(5) Patients with other musculoskeletal or neurological disorders, physical disabilities, or medical history not related to Duchenne muscular dystrophy, including pulmonary and cardiac disease
- •(6) Patients with a history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, or allergic disease
- •(7) Patients who have participated in another clinical trial within 30 days or 5 times the half-life of the other investigational drug or product
- •(8) Patients treated with androgen or human growth hormone within the past 3 months
- •(9) Patients with drug hypersensitivity or allergic predisposition
- •(10) Patients with hypersensitivity to corticosteroids or antihistamines used concomitantly with the investigational product
- •(11) Patients who have received exon-skipping therapy within 3 months prior to the first dose of the investigational product
- •(12) Patients who have received gene therapy
- •(13) Patients who have undergone surgery within 3 months prior to administration of the investigational product or are scheduled to undergo surgery during the study period
- •(14) Patients who have used other cell products within the past 3 months
- •(15) Patients with hypersensitivity to the products derived from pigs or humans
- •(16) Patients with positive results for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody tests at screening
- •(17) Patients considered ineligible by the investigator or sub investigators
研究者
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