Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

Официальное название

Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease

Обзор

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.

Вмешательства

• Препарат Allogeneic Bone-Marrow Derived Mesenchymal Stromal Cells Secretome
  Eye Drops
• Другое Vehicle Control
  Eye Drops

Первичные конечные точки

• Improvement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome) [Срок оценки: Baseline to Day 56]

Вторичные конечные точки (12)

• Visual Acuity [Срок оценки: Baseline to Day 56]
• Corneal staining and NEI grading [Срок оценки: Baseline to Day 70]
• Ocular Surface Parameters [Срок оценки: Baseline to Day 70]
• Corneal Epithelial Thickness [Срок оценки: Baseline to Day 70]
• Subject Symptoms [Срок оценки: Baseline to Day 70]
• Time to epithelial healing [Срок оценки: Baseline to Day 70]
• Corneal Opacities/Scars [Срок оценки: Baseline to Day 56]
• Corneal vascularization [Срок оценки: Baseline to Day 56]
• Conjunctival injection [Срок оценки: Baseline to Day 56]
• Subbasal corneal nerve density [Срок оценки: Baseline to Day 56]
• Ocular Surface Parameters [Срок оценки: Baseline to Day 70]
• Ocular Surface Parameters [Срок оценки: Baseline to Day 70]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Illinois at Chicago — Chicago

Идентификаторы

NCT: NCT06919081 · 2024-1426 · 3UH3EY031809-04S1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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