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Allogenic Corneal-Derived Adult Keratocytes, Ex-Vivo Expanded

This article delves into the clinical trials investigating the use of Allogenic Corneal-Derived Adult Keratocytes, Ex-Vivo Expanded, in combination with other advanced therapies for treating severe corneal ulcers. These innovative studies aim to evaluate the safety, feasibility, and efficacy of nanostructured artificial corneas in patients who have not responded to conventional treatments. The trials focus on regenerating corneal tissue and improving visual outcomes for individuals with challenging corneal conditions.

Table of Contents

What is ALLOGENIC CORNEAL-DERIVED ADULT KERATOCYTES, EX-VIVO EXPANDED?

ALLOGENIC CORNEAL-DERIVED ADULT KERATOCYTES, EX-VIVO EXPANDED is an advanced therapy medicinal product that is being studied for the treatment of severe corneal ulcers[1]. This innovative treatment is part of a larger product called NANOULCOR, which combines these keratocytes with other cells to create a living tissue equivalent[2].

To understand this treatment, let’s break down the terms:

  • Allogenic: This means the cells come from a donor, not the patient themselves.
  • Corneal-derived: The cells are taken from the cornea, which is the clear front part of the eye.
  • Adult keratocytes: These are specialized cells found in the cornea that help maintain its structure and clarity.
  • Ex-vivo expanded: The cells are grown and multiplied in a laboratory before being used for treatment.

How Does It Work?

The treatment works by providing new, healthy cells to repair damaged corneal tissue. When a person has a severe corneal ulcer, the normal corneal cells are damaged or destroyed. By implanting these laboratory-grown keratocytes, along with other types of cells, doctors hope to regenerate the damaged cornea[1].

The cells are delivered as part of a nanostructured fibrin-agarose artificial cornea model called NANOULCOR. This artificial cornea is designed to mimic the structure of a natural cornea, providing a scaffold for the implanted cells to grow and integrate with the patient’s existing corneal tissue[2].

What Conditions Does It Treat?

This treatment is primarily being studied for severe corneal ulcers that do not respond to conventional treatments. These ulcers can be caused by various conditions, including[1][2]:

  • Genetic disorders (e.g., Riley-Day syndrome, Goldenhar-Gorlin syndrome)
  • Neurological conditions (e.g., multiple sclerosis)
  • Infections (e.g., herpes simplex, herpes zoster)
  • Injuries to the eye
  • Complications from eye surgeries
  • Certain medications
  • Autoimmune disorders

It may also be used to treat the sequelae (after-effects) of previous corneal ulcers, such as stromal thinning or fibrosis[2].

Current Clinical Trials

There are currently two clinical trials studying this treatment:

  1. A Phase IIb trial evaluating the clinical efficacy of NANOULCOR in patients with severe corneal ulcers[1].
  2. A multicenter trial to evaluate the safety and feasibility of the treatment in patients with advanced corneal trophic ulcers refractory to conventional treatment[2].

These trials aim to determine how well the treatment works compared to standard treatments, how safe it is, and how feasible it is to use in clinical practice.

Who Is Eligible for Treatment?

While the exact eligibility criteria may vary between trials, generally, patients who might be eligible for this treatment include[1][2]:

  • Adults (18 years or older) with severe corneal ulcers that haven’t responded to conventional treatments for at least 3-6 weeks
  • Patients with stromal involvement (damage to the middle layer of the cornea) that doesn’t reach the innermost layer (Descemet’s membrane)
  • Individuals without active eye infections
  • Those willing to use approved contraceptive methods during the study (if applicable)

Patients who may not be eligible include those with[1][2]:

  • Active eye infections
  • Certain systemic infections (e.g., HIV, hepatitis B or C)
  • Pregnancy or breastfeeding
  • Recent history of cancer
  • Recent participation in other clinical trials

Safety and Side Effects

As this is an experimental treatment, all potential side effects are not yet known. The clinical trials are designed to evaluate the safety of the treatment and monitor for any adverse events[1][2]. Some potential risks that are being monitored include:

  • Local, regional, or systemic infections
  • Induced corneal vascularization (growth of blood vessels into the cornea)
  • Graft-related issues (e.g., detachment or resorption of the artificial cornea)

Patients in the trials will be closely monitored for any side effects or complications.

Future Prospects

If the current clinical trials show positive results, this treatment could offer new hope for patients with severe corneal ulcers who don’t respond to conventional treatments. The researchers are not only looking at whether the treatment can heal the ulcers, but also whether it can improve visual acuity, reduce complications, and enhance patients’ quality of life[1].

However, it’s important to remember that this is still an experimental treatment. More research is needed to fully understand its effectiveness, safety, and long-term outcomes. Patients with severe corneal ulcers should discuss all available treatment options with their eye care professional.

Aspect Details
Study Type Phase IIb, randomized, controlled, unblinded, multicentre clinical trials
Treatment Nanostructured fibrin-agarose artificial cornea model (NANOULCOR) containing Allogenic Corneal-Derived Adult Keratocytes and Limbal Cells
Target Condition Severe corneal ulcers refractory to conventional treatment
Primary Objectives Evaluate safety, feasibility, and clinical efficacy in regenerating trophic defects
Secondary Objectives Assess time to healing, visual acuity improvement, reduction of complications, quality of life improvement
Inclusion Criteria Adults with severe corneal ulcers unresponsive to conventional treatment for 3-6 weeks
Exclusion Criteria Active ocular infection, endothelial decompensation, certain systemic diseases, pregnancy
Primary Endpoints Regeneration of trophic defect, adverse events, graft conditions, infection signs
Secondary Endpoints Changes in visual acuity, corneal complications, quality of life, feasibility of treatment

FAQ

  • What is the main purpose of these clinical trials? The main purpose of these clinical trials is to evaluate the safety, feasibility, and clinical efficacy of nanostructured artificial corneas containing Allogenic Corneal-Derived Adult Keratocytes in patients with severe corneal ulcers that have not responded to conventional treatments.
  • Who is eligible to participate in these trials? Eligible participants are adults (18 years or older) with severe corneal ulcers that have not responded to conventional medical treatment for at least 3-6 weeks. They must have stromal involvement that does not reach Descemet's membrane and no active ocular infection.
  • What is the treatment being tested in these trials? The treatment being tested is a nanostructured artificial cornea model called NANOULCOR, which contains Allogenic Corneal-Derived Adult Keratocytes and Allogenic Sclerocorneal Limbus Stem-Derived Adult Limbal Cells, both ex-vivo expanded.
  • What are the primary outcomes being measured in these trials? The primary outcomes include the regeneration of the corneal defect, incidence of adverse events, graft conditions (integrity, survival, or reabsorption), and signs of infection or induced corneal vascularization.
  • How long do these clinical trials last? The duration of these trials varies, but they typically include a treatment period and a follow-up period. One trial mentions a six-month follow-up, while the exact duration for the other is not specified in the provided information.

Ongoing Clinical Trials on Allogenic Corneal-Derived Adult Keratocytes, Ex-Vivo Expanded

  • Study on the Effectiveness of NANOULCOR for Patients with Severe Corneal Ulcers Using Allogenic Limbal Cells and Keratocytes

    Recruiting

    1 1
    Investigated drugs:
    Spain

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

    Not recruiting

    1 1
    Investigated drugs:
    Spain

Glossary

  • Corneal ulcer: A corneal ulcer is an open sore or erosion on the surface of the cornea, which is the clear, dome-shaped outer layer at the front of the eye. It can be caused by various factors and may lead to vision problems if left untreated.
  • Keratocytes: Keratocytes are specialized cells found in the cornea of the eye. They play a crucial role in maintaining the structure and transparency of the corneal tissue.
  • Ex-vivo expanded: This term refers to cells that have been grown and multiplied outside of the body in a laboratory setting before being used for treatment.
  • Stromal involvement: This refers to the condition where the corneal stroma, the thickest layer of the cornea, is affected by disease or injury.
  • Descemet's membrane: Descemet's membrane is a thin, strong layer of tissue that lies between the corneal stroma and the innermost layer of the cornea (endothelium).
  • Nanostructured artificial cornea: A bioengineered corneal substitute designed at the nanoscale level to mimic the structure and function of a natural cornea.
  • Limbal cells: Cells found in the limbal region of the eye, which is the border between the cornea and the sclera (white of the eye). These cells are important for corneal regeneration.
  • Trophic defect: A condition where there is impaired nutrition or maintenance of tissues, in this case, referring to the cornea.
  • Bullous keratopathy: A condition characterized by swelling of the cornea due to fluid buildup, often resulting from damage to the corneal endothelium.
  • Optical Coherence Tomography (OCT): A non-invasive imaging technique that uses light waves to take cross-section pictures of the retina and other structures in the eye.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-nanoulcor-for-patients-with-severe-corneal-ulcers-using-allogenic-limbal-cells-and-keratocytes/
  2. http://clinicaltrials.eu/trial/study-on-allogenic-stem-cells-and-amniotic-membrane-for-patients-with-advanced-corneal-ulcers-unresponsive-to-standard-treatment/