Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Epithelial Status Assessment
研究概览
简要总结
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use anterior segment Optical Coherence Tomography (OCT)/Scheimpflug Imaging, esthesiometry, and visual analogue scale (VAS) to assess treatment tolerability.
详细描述
The "Safety of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease" study is designed to evaluate the safety and maximal tolerated dose (MTD) of topical MSC Secretome eye drops in patients with chronic ocular surface disease through a dose-escalation study under a 28-day topical application protocol, and also obtain a preliminary observation on the following:
- Incidence of treatment emergent adverse events (TEAE) assessed at 28 days following treatment initiation
- Proportion of patients with improved corneal epithelial barrier at 28 days compared to baseline
- Final visual acuity, corneal epithelial thickness, corneal stromal haze, corneal sensation, and treatment tolerability
The objective is to determine the dose of MSC Secretome through a first-in-human study through a dose-escalation strategy targeting a toxicity rate of 33% or less.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients 18 years of age or older
- •Chronic corneal epithelial disease with fluorescein staining score ≥ 6 by NEI grading scale
- •Reduced corneal sensation (≤ 4 cm measured by Cochet Bonnet esthesiometry) in at least one corneal quadrant
- •A stable ocular surface with no objective clinical evidence of significant (> 50%) improvement/worsening of the epithelial disease in the last 30 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)
排除标准
- •Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).
- •Evidence of corneal ulceration with stromal loss > 10%
- •Presence of an epithelial defect ≥1.0 mm in the largest diameter in the affected eye
- •Presence of any size epithelial defect that has been persistent for more than 30 days
- •Patients unable to discontinue or intermittently remove therapeutic contact lens in the study eye (to apply drops) during the 4-week study period
- •History of any ocular surgery (including laser or refractive surgical procedures) in the affected eye within the 3 months prior to study enrollment
- •History of chemical injury within the last 6 months prior to study enrollment Known hypersensitivity to one of the components of the study or procedural medications (e.g.,fluorescein)
- •History of drug, medication or alcohol abuse or addiction
- •Use of any investigational agent within 4 weeks of screening visit
- •History of previous enrollment in the MSC Secretome Study at a lower dose
- •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
Low dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the lowest dose level.
干预措施: MSC Secretome Eye Drops (Biological)
Medium dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the medium dose level.
干预措施: MSC Secretome Eye Drops (Biological)
High dose of allogenic MSC drops
Escalating doses of allogenic MSC eye drops will be assigned at the high dose level.
干预措施: MSC Secretome Eye Drops (Biological)
结局指标
主要结局
Epithelial Status Assessment
时间窗: Day 28
The primary outcome measure is improved corneal epithelial barrier function at DAY #28assessed by viewing the cornea under slit lamp examination after instillation of sodium fluorescein, assessing the change from baseline in corneal fluorescein staining score. The presence/absence of an epithelial defect on DAY #28 will also be recorded.
次要结局
- Durability of Corneal Epithelial Status Improvement(Baseline, Days 7, 14, 28, 56, 90)
- Corneal Epithelial thickness(Baseline, Days 14, 28, 56, 90)
- Visual Acuity(Baseline, Days 7, 14, 28, 56, 90)
- Tolerability of MSC secretome drops(Baseline, Days 7, 14, 28, 56, 90)
- Corneal Scarring / Haze(Baseline, Days 14, 28, 56, 90)
- Time to Improvement of Corneal Epithelial Barrier(Baseline, Days 7, 14, 28, 56, 90)
研究者
Ali R Djalilian
Professor of Ophthalmology
University of Illinois at Chicago