Ongoing Clinical Trials for Ulcerative Keratitis
There are currently 2 ongoing clinical trials investigating new treatments for severe corneal ulcers that do not respond to standard medical therapy. Both trials are exploring advanced tissue-engineered artificial cornea products that use specially prepared stem cells and biological matrices to help regenerate damaged corneal tissue. These experimental treatments aim to offer hope to patients who have run out of conventional treatment options.
Clinical trial locations
- Spain
Study on the Effectiveness of NANOULCOR for Patients with Severe Corneal Ulcers Using Allogenic Limbal Cells and Keratocytes
This Phase IIb clinical trial is testing NANOULCOR, a nanostructured artificial cornea made from specially prepared cells combined in a biological matrix. The treatment uses allogenic sclerocorneal limbus stem-derived adult limbal cells and allogenic corneal-derived adult keratocytes, which are expanded outside the body and then formed into a living tissue equivalent.
Main inclusion criteria: Patients must be at least 18 years old and have trophic corneal ulcers that have not responded to usual medical treatments for at least 3 weeks. The ulcer may affect the stromal layer of the cornea but should not reach deeper structures like Descemet’s membrane. Patients who have had this type of ulcer before and now have lasting effects such as corneal thinning, clouding, or calcium deposits may also qualify. Women of childbearing age must have a negative pregnancy test, and both men and women must agree to use safe birth control methods during the study and for six months afterward.
Main exclusion criteria: Patients cannot participate if they have other eye conditions that could interfere with study results, are currently using medications that might affect eye healing, have had eye surgery in the last 3 months, are pregnant or breastfeeding, have known allergies to study medication ingredients, are participating in another clinical trial, have serious illnesses that could affect participation, or are unable to follow study procedures or attend required visits.
Trial focus: The study aims to evaluate how well NANOULCOR works in healing severe corneal ulcers compared to a control group. The artificial cornea is implanted into the affected eye, and researchers monitor the healing process, changes in vision, any complications that arise, and the overall quality of life of participants. The study includes a six-month follow-up period to assess the continued effectiveness and safety of the treatment. Researchers will also record any side effects and check that the implanted corneal construct remains intact without detaching or dissolving.
Investigational drug: NANOULCOR is a nanostructured fibrin-agarose artificial cornea model designed to help regenerate the damaged area of the cornea. It provides a scaffold that supports cell growth and tissue regeneration, potentially improving vision and healing the ulcer. This tissue-engineered product is specifically designed for ocular surface reconstruction.
Study on Allogenic Stem Cells and Amniotic Membrane for Patients with Advanced Corneal Ulcers Unresponsive to Standard Treatment
This trial is evaluating a human nanostructured artificial cornea that combines amniotic membrane with allogenic sclerocorneal limbus stem-derived adult limbal cells and allogenic corneal-derived adult keratocytes. The treatment is designed for patients with severe corneal disease who have no other effective treatment options available.
Main inclusion criteria: Patients must be at least 18 years old with no maximum age limit and have Stage 3 Mackie corneal ulcers that do not respond to conventional treatment. These ulcers may be caused by various conditions including certain syndromes, diabetes, multiple sclerosis, infections like herpes, or injuries. The disease must have lasted for at least 6 weeks. The corneal problem must involve the stromal layer but not reach the Descemet membrane, and there should be no active eye infection present. Patients must have normal blood test results, including specific counts of white blood cells, neutrophils, and platelets, as well as appropriate levels of liver enzymes and creatinine.
Main exclusion criteria: Patients are excluded if they have other eye diseases that could interfere with the study, have had eye surgery in the last 6 months, have active eye infections, are pregnant or breastfeeding, have a history of severe allergies (especially to eye medications), are currently in another clinical trial, have a history of drug or alcohol abuse, have uncontrolled diabetes with unstable blood sugar levels, have autoimmune diseases where the body’s immune system attacks its own cells, or have any condition that study doctors believe would make participation unsafe.
Trial focus: The study aims to assess the safety and practicality of this new treatment approach. The artificial cornea is implanted onto the eye, and researchers monitor the condition of the graft to ensure it remains intact and does not cause adverse effects. They also watch for signs of infection or unwanted blood vessel growth in the eye. Throughout the study, improvements in visual acuity (clarity of vision) and corneal transparency (how clear the cornea is) are assessed. The study also evaluates the overall quality of life of participants and uses advanced techniques like impression cytology and OCT mapping to examine the corneal surface. The trial is expected to continue until 2027.
Investigational drug: The Human Nanostructured Artificial Cornea is a tissue-engineered product created using advanced nanostructuring techniques to mimic the natural structure of the human cornea. It is intended to replace damaged corneal tissue by providing a new, healthy corneal surface, potentially improving vision and reducing symptoms associated with corneal ulcers. At the molecular level, this artificial cornea promotes healing and helps restore vision by mimicking the eye’s natural structure.
Summary
Both ongoing clinical trials for severe corneal ulcers are being conducted in Spain and focus on innovative tissue-engineered treatments using artificial cornea models. These trials represent important advances in treating patients who have exhausted conventional treatment options. Both studies use similar approaches involving specially prepared stem cells from the eye’s surface combined with biological scaffolds, though they differ slightly in their specific compositions and structural designs.
The NANOULCOR trial is in Phase IIb and uses a randomized controlled design to compare the treatment’s effectiveness against a control group. The second trial focuses primarily on safety and practicality assessment. Both trials require patients to have had unsuccessful conventional treatments for several weeks and exclude those with active infections, recent eye surgeries, or conditions that might interfere with study participation. These experimental treatments offer potential hope for patients with severe corneal ulcers that have led to corneal thinning, scarring, or other complications, though their effectiveness and safety are still being evaluated.