EUCTR2014-002845-23-PL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
- •3. LSCD secondary to unilateral or bilateral physical or chemical
- •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 evidence of central corneal (central 6 mm
- •diameter) involvement (including central corneal neo-vascularisation or
- •corneal opacity) according to the independent assessors;
- •4. Stability of LSCD, defined by a duration of disease of at least 24
- •months (12 months for minors) at the time of the Screening Visit and as
- •presence of continuum epithelium as per fluorescein staining scored as
- •none or trace;
- •5. Presence of severe impairment in visual acuity defined by a score
- •after best correction (i.e. Best Corrected Visual Acuity) equal or below
- •1/10 (or 20/200) at the Snellen chart (legal blindness);
- •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 vascularization
- •invasion), due to a recent burn (less than 24 months before screening
- •for adults and 12 months for minors), 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;
- •7. 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 (i.e. use of contrast medium in the
- •last two weeks) or any other invasive procedure which could
- •affect the integrity of the epithelium
研究者
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已完成
4 期
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