EUCTR2015-004592-74-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 COL7A1 cDNA FOR RESTORATION OF EPIDERMIS IN PATIENTS WITH RECESSIVE DYSTROPHIC EPIDERMOLYSIS BULLOSA. - HOLOGENE7
Holostem Terapie Avanzate s.r.l.0 个研究点目标入组 12 人开始时间: 2016年1月19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
- 入组人数
- 12
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. Informed consent will also include the possibility of additional transplantations and of the rolling over to the long-term extension period;
- •2.Adult male and female patients (=18 years old and < 55);
- •Paediatric patients aged 6 to 17 years will be also enrolled.
- •3.RDEB molecular characterization by mutation analysis;
- •4.NC1 or NC2 antibody immunofluorescence or staining positive in Western Blot;
- •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 or metastasizing SCCs;
- •4.Antibodies to type VII 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 require to undergo pregnancy test.
- •Parental control will be applied for the pediatric population when needed.
- •8.Allergy, sensitivity or intolerance to drugs or excipients (hypersensitivity to any of the excipients listed in Investigator’s brochure or in this protocol):
- •-Transport medium (Dulbecco’s Modified Eagles Medium supplemented with L-glutamine)
- •-Fibrin support
- •-Betaisodona
- •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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