EUCTR2014-002845-23-ES进行中（未招募）1 期
Multinational, multicentre, prospective, open-label, uncontrolled clinical trial to assess the efficacy and safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns - HOLOCORE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
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. Written informed consent prior to any study-related procedures;
- •2. Adult male and female patients (?18 years old) - [Five Paediatric patients aged 2 to 17 years will be also enrolled for safety purposes only];
- •3. LSCD secondary to unilateral or bilateral ocular burns, with at least 1-2 mm2 of undamaged limbus to harvest stem cells for expansion in culture. LSCD will be considered for inclusion in presence of superficial neo-vascularization invading at least two corneal quadrants with central corneal involvement (including corneal neo-vascularisation, corneal opacity or corneal dyschromia) according to the independent assessors;
- •4. Stability of LSCD, defined by a duration of disease of at least 24 months at the time of the Screening Visit and presence of continuum epithelium as per fluorescein staining scored as none or trace;
- •5. Presence of severe impairment in visual acuity at the Snellen chart (legal blindness) after best correction (i.e. Best Corrected Visual Acuity);
- •6. Absence of other clinical contraindications to ACLSC transplantation based upon investigator?s judgment;
- •7. 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: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 73
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. LSCD of mild degree (i.e. below 2 quadrants of neo-vessel invasion without central corneal), due to a recent burn (less than 24 months before screening), or secondary to medical conditions other than burns (i.e.radiotherapy);
- •2. Severe ocular inflammation according to the Efron Grading Scale for Contact Lens Complications. Patient can be re-screened after appropriate treatment;
- •3. Presence of eyelids malposition;
- •4. Conjunctival scarring with fornix shortening;
- •5. Tear secretion deficiency, determined by Schirmer?s test (<5 mm/ 5 min);
- •6. Corneal anaesthesia and conjunctival anaesthesia or severe hypoesthesia;
研究者
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已完成
4 期
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