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Study on Allogenic Stem Cells and Amniotic Membrane for Patients with Advanced Corneal Ulcers Unresponsive to Standard Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a severe eye condition known as corneal trophic ulcers. These ulcers are advanced and do not respond to standard eye treatments. The study aims to evaluate a new treatment using a special type of artificial cornea, called a nanostructured artificial human cornea. This treatment involves using a combination of human tissues, including the amniotic membrane and allogenic sclerocorneal limbus stem-derived adult limbal cells, which are cells taken from the eye's surface and expanded outside the body. The treatment is designed to help patients who have no other effective options for their severe corneal disease.

The purpose of the study is to assess the safety and practicality of this new treatment approach. Participants in the study will receive the treatment through a process called implantation, where the artificial cornea is placed onto the eye. The study will monitor the condition of the graft, which is the implanted cornea, to ensure it remains intact and does not cause any adverse effects. Researchers will also look for any signs of infection or unwanted blood vessel growth in the eye.

Throughout the study, the health of the participants' eyes will be closely observed. This includes checking for improvements in visual acuity, which is the clarity of vision, and corneal transparency, which refers to how clear the cornea is. The study will also assess the overall quality of life of the participants and use techniques like impression cytology and OCT mapping to examine the surface of the cornea. The trial is expected to continue until 2027, providing valuable insights into the potential of this innovative treatment for those suffering from severe corneal conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include having stage 3 Mackie corneal ulcers that do not respond to conventional treatment, among other specific conditions.

  2. Step 2

    Informed consent

    Participants must provide informed consent, acknowledging understanding of the study's purpose and procedures.

  3. Step 3

    Pre-treatment evaluation

    A comprehensive eye examination is performed to assess the current condition of the corneal ulcer and any associated symptoms.

    Laboratory tests are conducted to ensure normal blood parameters, such as leukocytes, neutrophils, and platelets.

  4. Step 4

    Treatment administration

    The treatment involves the implantation of a human nanostructured artificial cornea, which is a living tissue equivalent.

    This product is composed of amniotic membrane and allogenic sclerocorneal limbus stem-derived adult limbal cells, combined with allogenic corneal-derived adult keratocytes.

  5. Step 5

    Post-treatment monitoring

    Regular follow-up visits are scheduled to monitor the condition of the graft, including its integrity and survival.

    The incidence of any adverse events is recorded, along with signs of infection or induced corneal vascularization.

  6. Step 6

    Evaluation of outcomes

    The primary outcomes include the incidence of adverse events and the condition of the graft.

    Secondary outcomes focus on ulcer persistence, visual acuity, corneal transparency, and quality of life assessments.

Who can join the trial?

8 criteria

  • Patients must give their informed consent to participate in the study. This means they agree to join the study after understanding what it involves.
  • Patients must have Stage 3 Mackie corneal ulcers that do not respond to regular medical treatment. These ulcers can be caused by various conditions such as certain syndromes, diabetes, multiple sclerosis, infections like herpes, or injuries.
  • Patients who have had Stage 3 Mackie corneal ulcers in the past and are now experiencing issues like corneal thinning or scarring, with no other effective treatment options available.
  • The corneal problem must involve the stromal layer of the eye but not reach the Descemet membrane. It can be located in the center or on the edges of the cornea.
  • There should be no active eye infection present.
  • Participants can be men or women aged 18 or older, with no maximum age limit.
  • The disease causing the corneal ulcer must have lasted for at least 6 weeks.
  • Patients must have normal blood test results, including a certain number of white blood cells, neutrophils, and platelets, as well as specific levels of liver enzymes (AST/ALT) and creatinine, which is a measure of kidney function.

Who cannot join the trial?

10 criteria

  • Patients with other eye diseases that could interfere with the study.
  • Patients who have had eye surgery in the last 6 months.
  • Patients with active eye infections.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergies, especially to eye medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients with uncontrolled diabetes, which means their blood sugar levels are not stable.
  • Patients with autoimmune diseases, which are conditions where the body's immune system attacks its own cells.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Human Nanostructured Artificial Cornea is a tissue-engineered product designed to replace damaged corneal tissue in patients with severe corneal disease. This artificial cornea is created using advanced nanostructuring techniques to mimic the natural structure of the human cornea. It is intended to help patients who have not responded to conventional ophthalmic treatments by providing a new, healthy corneal surface, potentially improving vision and reducing symptoms associated with corneal ulcers.

What is already known about the treatment

Human Nanostructured Artificial Cornea – This medication is administered as an implant directly into the eye, specifically designed for patients with severe corneal trophic ulcers that do not respond to standard treatments. Currently, it is being evaluated in clinical trials to assess its safety and effectiveness. The main therapeutic indication is for advanced corneal ulcers, which may include complications like stromal thinning or fibrosis. At the molecular level, this artificial cornea works by mimicking the natural structure of the cornea, promoting healing and restoring vision. It falls under the pharmacological classification of tissue-engineered products.

Investigated diseases

Corneal Trophic Ulcers – These are open sores on the cornea that do not heal with standard treatments. They can lead to thinning or scarring of the corneal tissue. The ulcers may be associated with or without limbal insufficiency, which affects the eye's ability to regenerate its surface. Over time, these ulcers can cause significant discomfort and vision problems. The condition may persist or worsen, leading to further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515481-13-00Protocol codeCAH/Ulc/2010Estimated enrolment20 patientsSponsorRed Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).