EUCTR2018-001009-98-DE进行中（未招募）1 期
An interventional, multicenter, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-EB on epidermolysis bullosa (EB)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female patients aged between =12 months and =55 years,
- •Staggered design for patient enrollment:
- •1.) at least 3 adult patients =18 to =55 years (safety assessment 2 weeks after last treatment of third patient),
- •2.) at least 3 patients =12 to <18 years (safety assessment 2 weeks after first treatment of third patient),
- •3.) at least 3 patients =5 to <12 years (safety assessment 2 weeks after first treatment of third patient) and
- •4.) at least 3 patients =12 months to <5 years (safety assessment 2 weeks after first treatment of third patient);
- •2. Diagnosed with RDEB (combined diagnoses by genotype assessment [mutation analysis] and correlating phenotype assessment [wound assessment]), patients must have a negative immunofluorescence test result on salt-split skin against proteins of the basement membrane at Visit 1 (existing test results will be accepted);
- •3. Patient is eligible to participate in this clinical trial based on general health condition at the investigator’s discretion;
- •4. Patient/legal representative understands the nature of the procedure and are providing written informed consent prior to any clinical trial procedure;
- •5. Women of childbearing potential must have a negative urine pregnancy test at Visit 1;
- •6. Women of childbearing potential and their partner must be willing to use highly effective contraceptive methods during the course of the clinical trial.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Tumor diseases or history of tumor disease;
- •2. Positive test result for human immunodeficiency virus 1 and/or 2 at Screening;
- •3. Any known allergies to components of the IMP;
- •4. Evidence of any other medical conditions (such as psychiatric illness or active infection) based on physical examination, or laboratory findings that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment; at investigators discretion;
- •5. Inadequate pulmonary function with evidence of chronic obstructive or severe restrictive pulmonary disease;
- •6. Inadequate cardiac function with evidence of uncontrolled high blood pressure, congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to treatment;
- •7. History of prior thrombosis or patients at risk for thrombosis
- •8. Clinically significant or unstable concurrent disease or other clinical contraindications to IMP application (based upon investigator’s judgment);
- •9. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol;
- •10. Pregnant or lactating women;
- •11. Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
- •12. Previous participation in this clinical trial (except for screening failures due to an exclusion criterion);
- •13. Known abuse of alcohol, drugs, or medicinal products;
- •14. Employees of the sponsor, or employees or relatives of the investigator.
研究者
相似试验
进行中（未招募）
1 期
Study to investigate the efficacy and safety of allo-APZ2-EB on wound healing of epidermolysis bullosa (EB)Recessive dystrophic epidermolysis bullosa (RDEB)MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-001009-98-ITRHEACELL GmbH & Co. KG18
进行中（未招募）
1 期
Study to investigate the efficacy and safety of allo-APZ2-EB on wound healing of epidermolysis bullosa (EB)Recessive dystrophic epidermolysis bullosa (RDEB)MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-001009-98-GBRHEACELL GmbH & Co. KG16
进行中（未招募）
1 期
Study to investigate the efficacy and safety of allo-APZ2-EB on wound healing of epidermolysis bullosa (EB)Recessive dystrophic epidermolysis bullosa (RDEB)MedDRA version: 20.0Level: PTClassification code 10014989Term: Epidermolysis bullosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-001009-98-ATRHEACELL GmbH & Co. KG16
进行中（未招募）
1 期
Study to investigate the efficacy and safety of allo-APZ2-EB on wound healing of epidermolysis bullosa (EB)Recessive dystrophic epidermolysis bullosa (RDEB)MedDRA version: 20.0 Level: PT Classification code 10014989 Term: Epidermolysis bullosa System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2018-001009-98-FRRHEACELL GmbH & Co. KG18
进行中（未招募）
1 期
Study to investigate the efficacy and safety of allo-APZ2-DFU on wound healing of diabetic neuropathic ulcer.EUCTR2017-000234-57-DERHEACELL GmbH & Co. KG37