EUCTR2016-000095-17-AT进行中（未招募）1 期
PROSPECTIVE, OPEN-LABEL, UNCONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFICACY OF AUTOLOGOUS CULTURED EPIDERMAL GRAFTS CONTAINING EPIDERMAL STEM CELLS GENETICALLY MODIFIED WITH A GAMMA-RETROVIRAL (RV) VECTOR CARRYING COL17A1 cDNA FOR RESTORATION OF EPIDERMIS IN PATIENTS WITH JUNCTIONAL EPIDERMOLYSIS BULLOSA - HOLOGENE 17
Holostem Terapie Avanzate s.r.l.0 个研究点开始时间: 2017年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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)Signed and dated informed consent prior to any study-related procedures;
- •2)Male and female patients between 6 years old to 55 years old;
- •3)JEB molecular characterization by mutation analysis;
- •4)NC16A antibody immunofluorescence or positive staining in Western Blot analysis with polyclonal antibody produced against a synthetic peptide corresponding to amino acids 131-145 of human COL17A1;
- •5)Presence of chronic (persistent or recurrent for more than 3 months) large wounds (>10 cm2) and/or persistent or recurrent erosions;
- •6)A cooperative attitude to follow up the study procedures (Caregivers in case of minors).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known or suspected intolerances against anaesthesia;
- •2. Bad general condition (ECOG index >1);
- •3. Unresectable metastasizing Squamous Cell Carcinomas (SCCs);
- •4. Antibodies to type XVII collagen associated antigens demonstrated on indirect immunofluorescence;
- •5. Clinical and/or laboratory signs of acute systemic infections at the time of screening. Patient can be re-screened after appropriate treatment;
- •6. Severe systemic diseases (i.e. uncompensated diabetes);
- •7. Female subjects: pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS they are willing to use one or more reliable methods of contraception with a Pearl index =1. Reliable contraception should be maintained throughout the study.
- •A pregnancy test in urine will be performed at screening in all women of childbearing potential, and repeated before biopsy treatment and at all visits. Any postmenopausal women (physiologic menopause defined as 12 consecutive months of amenorrhea”) or women permanently sterilized (e.g. tubal occlusion, hysterectomy or bilateral salpingectomy) will not be required to undergo pregnancy test.
- •Parental control will be applied for the pediatric population when needed;
- •8. Allergy, sensitivity or intolerance to drugs, excipients or other material (as per Investigator’s brochure):
- •Transport medium (Dulbecco’s Modified Eagles Medium supplemented with L-glutamine); Fibrin support; Povidone iodine;
- •9. Contraindications to the local or systemic antibiotics and/ or corticosteroids foreseen by the protocol;
- •10. Contraindications to undergo extensive surgical procedures;
- •11. Clinically significant or unstable concurrent disease or other clinical contraindications to stem cell transplantation based upon investigator’s judgment or other concomitant medical conditions affecting grafting procedure;
- •12. Patients (or parents in case of paediatric subject) unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study procedures and treatments;
- •13. Participation in another clinical trial where investigational drug was received less than 6 months prior to screening Visit.
研究者
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