EUCTR2014-002845-23-IT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). - 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
- 80
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. Informed consent will also include the possibility of a second transplantation and of the rolling over to the long-term extension study HOLOCORE-FU. In case the patient will be judged by the investigator as eligible to a second transplantation, an additional written addendum to the first informed consent form will have to be obtained to proceed with the second ACLSCT;
- •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 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 central corneal involvement (including corneal neo-vascularization 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 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 1/10th (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:
- •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 ), 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
- •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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