Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal T… (NCT01765244) | Clinical Trial Compass
CompletedPhase 1/2
Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment
Spain16 participantsStarted 2014-01-17
Plain-language summary
This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Man or woman aged≥18, with no upper age limit.
* Patients that give their informed consent for study participation.
* Stage 3 Mackie corneal ulcers that do not respond to conventional medical treatment, or patients having undergone previous stage 3 Mackie corneal ulcers,33 currently suffering sequelae such as stromal fibrosis or corneal thinning, having no effective therapeutic alternative.
* Stromal involvement, not reaching the Descemet membrane. Central or peripheral localization.
* Minimum duration of the disease causing the corneal ulcer: 6 weeks.
* No active ocular infection.
* Patients with normal laboratory parameters as defined by: Leukocytes≥3000 cells/µL; Neutrophils≥1500 cells/µL; Platelets≥100 billion/L; AST/ALT≤1.5 ULN; Creatinine≤1.5 mg/dL.
Exclusion Criteria:
* Absence of stromal involvement.
* Good response to standard medical treatments for corneal disease in less than 3 to 5 weeks.
* Bullous keratopathy or other endothelial decompensations.
* Active ocular infection.
* Positive serology to HBV, HCV, HIV or any other pathology that may interfere with correct patient follow-up.
* Pregnant or breast-feeding women or childbearing-age women that do not consent the use of contraceptive methods approved in the protocol.
* Medical history of active neoplasia within the past 5 years. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events (and serious adverse events) causally related to experimental treatment.
Timeframe: 24 months
2
Implant status (integrity, detachment and reabsorption)
Timeframe: 24 months
3
Local, regional or systemic infections related with the implant
Timeframe: 24 months
4
Induced corneal neovascularization
Timeframe: 24 months
Trial details
NCT IDNCT01765244
SponsorAndalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud