CTRI/2020/07/026891进行中（未招募）1 期
A proof of concept study to evaluate the clinical safety and efficacy of Ex-vivo Cultivated Allogeneic Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •1.Male and female participants who are >=18 and <= 60 years of age.
- •2.Patients having unilateral superficial corneal pathologies (defined as involving the anterior 200µM of the corneal stroma on ASOCT imaging)
- •3.Corneal burns, ulcers and scars
- •4.No prior history of corneal transplantation
- •5.No ongoing and other active ocular pathology
- •6.Candidate for stem cell transplant
- •7.No severe pathological and psychological conditions that might interfere with the patientâ??s participation in the study
- •8.Able to provide written and audio-visual informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, for any reason without prejudice
排除标准
- •1.Bilateral corneal disease,
- •2.Corneal scars with limbal dysfunction (clinically defined as absent limbal palisades or conjunctivalization of the cornea)
- •3.Ocular surface disease including dry eye disease (defined as a Schirmerâ??s test of less than 10mm at 5 minutes),
- •4.Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation,
- •5.Children ( <18 years of age),
- •6.Less than 3 months after documented clinical resolution of acute disease
- •7.Inability/refusal to give written informed consent
- •8.Undergo any of the anterior segment imaging tests.
- •9.Patient should have not participated in another clinical study within 30 days of their enrolment on this study.
- •10.History or evidence of cardiac disease: congestive heart failure; New York Heart Association (NYHA) class 2 or greater (see Appendix 6); active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, atrio-ventricular block of second or third degree, or uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction (MI) or coronary revascularization.
- •11.Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential
- •12.Reproductive age patients not practicing effective and adequate birth control measures
- •13.Previous participation in this study
研究者
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