Autologous Cultivated Limbal Stem Cell Transplantation on Amniotic Membrane Scaffold to Achieve Corneal Surface Repair and Visual Rehabilitation.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Possible corneal re-epithelialization in the patients suffering from Limbal stem cell deficiency
研究概览
简要总结
The clinical trial is a non-randomized non-blinded, single centre interventional study to assess the efficacy of autologous limbal stem cells (LSC) expanded on decellularized human amniotic membrane (HAM) as a dual transplant to cure unilateral limbal stem cell deficiency (LSCD). LSCD is an extremely debilitating eye disorder which is painful and cause blinding. In the proposed clinical trial, decellularized human amniotic membrane (HAM) will be used as surrogate niche for ex-vivo expansion of LSC and the same will be transplanted on LSCD patients. We expect that treated patients will show corneal re-epithelialization, the primary outcome of our clinical trial. As a secondary outcome, there will be improved visual acuity and improved quality of life of in LSCD patients. Additionally, a centre for limbal stem cell transplantation at KS Hegde Charitable Hospital, NITTE (DU) can be established to treat LSCD patients of Karnataka and neighbouring districts of Kerala.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Unilateral limbal stem cell deficiency caused due to
- •ocular burns,
- •chemical injury,
- •injury due to UV radiation,
- •Ocular surface squamous neoplasia,
- •recurrent pterygium,
- •mild cases of Stevens-Johnson syndrome
- •Mucous membrane pemphigoid.
排除标准
- •patients with bilateral corneal disease,
- •Ocular surface disease including dry eye disease, defined as a Schirmer’s test of less than 10mm at 5 minutes,
- •h/o prior history of corneal transplantation
- •h/o ongoing and other active ocular pathology
- •h/o severe pathological and psychological conditions that might interfere with the patient’s participation in the clinical trial
- •Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation,
- •Inability/refusal to give written informed consent
- •History or evidence of cardiac disease: congestive heart failure, 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.
- •Pregnant and lactating patients, positive urine pregnancy test in women of childbearing potential.
结局指标
主要结局
Possible corneal re-epithelialization in the patients suffering from Limbal stem cell deficiency
时间窗: Day1 | Day7 | Day15 | Day 30 | Day 60 | Day 90 | Day 180 | Day 360
次要结局
- Improvements in the visual acuity due to possible corneal re-epithelialization.(After successful completion of proposed clinical trial, a centre for limbal stem cell transplantation at KS Hegde Charitable Hospital, NITTE (DU) can be established to treat)
研究者
Dr Vaishakha S Shetty
K.S Hegde Medical Academy