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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 study about?

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.

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 informed consent

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

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitario Puerta Del Mar Cadiz Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario Virgen De Valme Sevilla Spain
Clinica De Oftalmologia De Cordoba S.L. Cordoba Spain
Hospital Costa del Sol Marbella Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
17.01.2014

Trial locations

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.

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 ID:
2024-515481-13-00
Protocol code:
CAH/Ulc/2010
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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