JPRN-jRCT2033210128招募中3 期
A confirmatory clinical study to evaluate efficacy and safety of ISN001 in patients with epidermolysis bullosa
Ishiko Akira0 个研究点目标入组 8 人开始时间: 2021年5月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
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
- >= 1age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Subject is eligible for the trial if it meets all of the following inclusion criteria:
- •(1) Dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB), or Dowling-Meara type of epidermolysis bullosa simplex (EBS) patient, diagnosed according to the intractable disease diagnostic criteria designated by the Ministry of Health, Labor and Welfare
- •(2) Subject with skin ulcer lesions of epidermolysis bullosa meet the following criteria, on Visit 1 (Day starting the observation) in screening phase and Visit 3 (Day starting treatment):
- •1) Subject has the skin ulcers lesion continuously lasting during the observation period in screening phase
- •2) Subject with the skin ulcer lesion with total size of 10 - 250 cm2
- •(3) Subject with the size of skin ulcer lesion with (+/-) 20% change at both Visit 2 (Day of two weeks after Visit 1) and Visit 3 (Day starting treatment) in comparison to Visit 1
- •(4) Subject who has no clinical signs related to infection, or no visible necrosis in the ulcer lesion where ISN001 is applied
- •(5) Subject aged 1 - 70 years on the date of consent
- •(6) Outpatient or hospitalized patient
- •(7) Prior to recruitment, subject or his/her legal deputy (in the case of an infant subject, both the subject and the deputy) sign the form of informed consent after the nature of the trial and the profile of clinical product are explained
排除标准
- •Subject with the following criteria / condition is excluded from the trial:
- •(1) Subject with the following medical history
- •1) Severe allergy (shock, anaphylaxis symptoms)
- •2) Cutaneous hypersensitivity to topical medications
- •3) Allergy to bovine or porcine protein or constituent of fibrin hydrogel sheet
- •4) Allergy to penicillin, streptomycin or amphotericin B
- •(2) Subject with malignant tumor or with a history of malignant tumor within 5 years before Visit 1 (Day stating observation)
- •(3) Subject with advanced hepatic, cardiac or pulmonary disorders requiring hospitalization, providing that subject undergoing hemodialysis may be associated with renal amyloidosis, so the PI (principal investigator) or sub-investigator in charge of the trial should carefully determine if the recruitment is appropriate or not
- •(4) Subject with the following condition within 1 year prior to recruitment:
- •1) Drug abuse
- •2) Alcohol abuse
- •(5) Subject enrolled into the other trial within 4 months prior to recruitment
- •(6) Subject enrolled into the other clinical trial of regenerative medicine or treated with regenerative medicine within 1 year prior to recruitment
- •(7) Subject under treatment with JACE (ragistered name) or treated within one year prior to Visit 3 (Day starting treatment)
- •(8) Subject enrolled into ISN001-EB-01 clinical trial and applied with ISN001
- •(9) Subject received the following medication within 4 weeks prior to Visit 1 (Day starting observation):
- •1) Subject under 18 years old received oral treatment with corticosteroids over 0.5mg/kg a day for 2-weeks
- •2) Subject over 18 years old received oral treatment with corticosteroids over 20mg a day for 2 weeks
- •3) Subject received topical treatment with corticosteroids, providing that this does not apply except in the area where ISN001 is applied (planned)
- •4) Subject received biological product (except vaccine)
- •5) Subject received radiation therapy or immunosuppressant medication
- •(10) Subject with HBS-antigen, HCV antibody, or HIV antibody test positive
- •(11) Subject with the following condition in the clinical laboratory test on Visit 1 (Day starting observation):
- •1) serum BUN or serum CREA more than double the upper limit of the standard value
- •2) AST, ALT, ALP, T-Bil or TP more than double the upper limit of the standard value
- •3) Blood albumin below 2.0 g/dL
- •4) Blood hemoglobin below 6.0 g/dL
- •(12) Subject requires antibiotics due to bacterial infection on skin ulcer lesion where ISN001is applied (planned) during the observation period from Visit 1 to Visit 3
- •(13) Female subjects: pregnant, lactating patient, patient not intend to contraceptive during the trial period, patient received pregnancy test (serum hCG) on Visit 1 and it exceeds the upper limit of the standard value
- •(14) Subject considered not suitable for the trial by PI or sub-investigator in charge
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