KCT0004741已完成未知
Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency
CliPS0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1)Men and women aged 19 or older
- •2)Patients diagnosed with intractable limbal stem cell deficiency in single eye who have severity in which corneal neovascularization invades more than two quadrants
- •3)Patients who do not have improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
- •4)Those whose best corrected visual acuity of the eye with the limbal stem cell deficiency at screening is 20/40 or less
- •5)Patients who voluntarily agreed to participate in this study and signed a consent form
排除标准
- •1)Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
- •2)If it is judged to be difficult to reconstruct the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
- •3)Severe dry eye patients with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia at screening < 2 mm/5 min)
- •4)Patients confirmed with acute ocular surface inflammation of both corneas at Visit 2
- •5)Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
- •6)Patients with uncontrolled comorbidities such as moderate to severe infections and bleeding
- •7)Positive for virus infection (HBV, HCV, HIV, CMV, HTLV?/?, syphilis)
- •8)Uncontrolled diabetic patients (HbA1c =9.0%)
- •9)Hypertension patients whose blood pressure is not controlled below SBP 140mmHg or DBP 90mmHg despite taking antihypertensives at screening
- •10)Uncontrolled glaucoma patients with intraocular pressure (IOP) above 21 mmHg despite taking glaucoma medication
- •11)Pregnant or lactating women
- •12)Among women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials (*hormonal contraception, intrauterine device (Intrauterine device (IUD) or Intrauterine system (IUS)), fallopian ligation, double barrier method (Combination use of barrier methods such as male condom, female condom, cervical cap, contraceptive diaphragm, and contraceptive sponge)
- •13)Those who participated in another clinical study within 4 weeks prior to participation in this study and have received an investigational product or have undergone a procedure with an investigational medical device
- •14)Other patients judged by the investigator to be inappropriate to participate in the clinical study
研究者
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