NL-OMON50240已完成4 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
Holostem Terapie Avenzate S.r.l0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
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 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 corneal neo-vascularisation and
- •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).
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 less
- •than 12 months before screening 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. Severe tear secretion
- •deficiency, determined by Schirmer*s test type 1 (<5 mm/ 5 min);, 6. Corneal
- •anaesthesia and conjunctival anaesthesia or severe hypoesthesia;, 7. Active
- •local or systemic infections at the time of screening. Patient can be
- •re-screened after appropriate treatment;, 8. Diagnosis of local or systemic
- •neoplastic disease;, 9. Congenital diseases (i.e., Aniridia);, 10. Bilateral
- •inflammatory diseases (i.e. Stevens-Johnson syndrome, phemphigoid);, 11. A
- •pre-existing blindness precluding a functional recovery;, 12. Female subjects:
- •pregnant or lactating women and all women physiologically capable of becoming
- •pregnant (i.e. women of childbearing potential) UNLESS are willing to use one
- •or more reliable methods of contraception (e.g. oral contraceptives, IUD, tubal
- •ligature). 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 and treatment. Any
- •postmenopausal women (physiologic menopause defined as *12 consecutive months
- •of amenorrhea*) or women permanently sterilized (e.g. tubal occlusion,
- •hysterectomy or bilateral salpingectomy) may be enrolled in the study
- •Parental control will be applied for the paediatric population when needed;,
- •13. Allergy, sensitivity or intolerance to concomitant drugs or excipients
- •(Hypersensitivity to any of the excipients listed in section 6.1 or to bovine
- •serum and murine 3T3-J2 cells);, 14; Contraindications to the local or systemic
- •antibiotics and/ or corticosteroids foreseen by the protocol;, 15.
- •Contraindications to the surgical procedure;, 16. 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;, 17. 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;, 18. Participation in
- •another clinical trial where investigational drug was received less than 4
- •weeks prior to screening visit.
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