Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)
研究概览
简要总结
In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age · Patients 18 years of age or older
- •Ocular Health
- •Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment
- •No objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 14 days
- •Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)
- •If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.
- •Study Procedures
- •Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.
排除标准
- •Ocular Health
- •Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
- •History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.
- •Treatment with Oxervate in the study eye within 12 months of enrollment.
- •Study Procedures
- •Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).
- •Use of any investigational agent within 4 weeks of screening visit.
- •Participation in another clinical study at the same time as the present study.
- •Participants who are pregnant at the time of study enrollment.
研究组 & 干预措施
Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome for Topical Eye Drop
干预措施: Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome (Drug)
Vehicle
Vehicle (unconditioned media)
干预措施: Vehicle Control (Other)
结局指标
主要结局
Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)
时间窗: Baseline to Day 56
Proportion of subjects with improved epithelial barrier and/or integrity from baseline to DAY 56 as determined by the investigator on slit lamp examination: · Improved epithelial barrier, defined as ³ 50 % improvement in corneal fluorescein staining score using NEI grading scale · Improved epithelial integrity, defined as complete closure of persistent epithelial defect, measured with ImageJ on slit lamp images
次要结局
- Time to epithelial healing(Baseline to Day 70)
- Ocular Surface Parameters(Baseline to Day 70)
- Visual Acuity(Baseline to Day 56)
- Corneal staining and NEI grading(Baseline to Day 70)
- Corneal Epithelial Thickness(Baseline to Day 70)
- Subject Symptoms(Baseline to Day 70)
- Corneal Opacities/Scars(Baseline to Day 56)
- Corneal vascularization(Baseline to Day 56)
- Conjunctival injection(Baseline to Day 56)
- Subbasal corneal nerve density(Baseline to Day 56)
研究者
Ali R Djalilian
Principal Investigator
University of Illinois at Chicago