NCT04773431已完成1 期
Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency
CliPS Co., Ltd1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Rate of Adverse event
研究概览
简要总结
Clinical Study Objective:
To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency
Study Method:
Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 19 or older
- •Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
- •No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
- •BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
- •Voluntarily agreed to participate in this study and signed a consent form
排除标准
- •Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
- •Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
- •Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia < 2 mm/5 min at screening)
- •Acute ocular surface inflammation of both corneas at Visit 2
- •Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
- •Uncontrolled comorbidities such as moderate to severe infections and bleeding
- •Positive for virus infection (HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, syphilis)
- •Uncontrolled diabetes (HbA1c ≥9.0%)
- •Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite taking antihypertensives at screening)
- •Uncontrolled glaucoma (IOP > 21 mmHg despite taking glaucoma medication)
- •Pregnant or lactating women
- •Women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials
- •Participation in another clinical study within 4 weeks
- •Subjects judged by the investigator to be inappropriate to participate in the clinical study
研究组 & 干预措施
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
Experimental
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
干预措施: LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation (Drug)
结局指标
主要结局
Rate of Adverse event
时间窗: From limbal tissue collection until 24 weeks after transplantation
Adverse event
次要结局
- Rate of normal/abnormal results in clinical laboratory test(Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation)
- Blood pressure(systolic/diastolic) at each visit(Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation)
- Pulse rate at each visit(Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation)
- Rate of normal/abnormal results in Electrocardiogram(Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation)
- Rate of normal/abnormal results in physical examination at each visit(Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation)
- Rate of eye infection and inflammation(Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation)
- Intraocular pressure test(Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation)
研究者
研究点 (1)
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