An interventional, multicenter, single arm, phase I/IIa clinical trial to investigate the efficacy and safety of allo-APZ2-EB on epidermolysis bullosa (EB). - allo-APZ2-EB-II-01

RHEACELL GmbH & Co. KG0 个研究点目标入组 18 人开始时间: 2020年11月10日最近更新: 2020年11月16日

研究概览

暂无简介。

•1. Male or female patients aged between =18 years and =55 years; After positive safety assessment of 3 treated patients (=18 years and =55 years): male or female patients aged between =12 months and =55 years;
•2. Diagnosed with RDEB;
•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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Tumor diseases or history of tumor disease;
•2. Known positive result for human immunodeficiency virus 1 and/or 2;
•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. History of prior thrombosis or patients at risk for thrombosis;
•6. Clinically significant or unstable concurrent disease or other clinical contraindications to IMP application (based upon investigator's judgment);
•7. Patient/legal representative anticipated to be unwilling or unable to comply with the requirements of the protocol;
•8. Pregnant or lactating women;
•9. Current or previous (within 30 days of enrollment) treatment with another IMP, or participation and/or under follow-up in another clinical trial;
•10. Previous participation in this clinical trial (except for screening failures due to an exclusion criterion);
•11. Known abuse of alcohol, drugs, or medicinal products;
•12. Employees of the sponsor, or employees or relatives of the investigator.

发起方