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Allogenic Sclerocorneal Limbus Stem-Derived Adult Limbal Cells, Ex-Vivo Expanded

This article discusses clinical trials investigating the use of Allogenic Sclerocorneal Limbus Stem-Derived Adult Limbal Cells, Ex-Vivo Expanded, in treating severe corneal ulcers. These advanced therapy trials aim to evaluate the safety, feasibility, and effectiveness of nanostructured artificial corneas for patients who have not responded to conventional treatments. The studies focus on regenerating damaged corneal tissue and improving visual outcomes for those with challenging eye conditions.

Table of Contents

What is this treatment?

ALLOGENIC SCLEROCORNEAL LIMBUS STEM-DERIVED ADULT LIMBAL CELLS, EX-VIVO EXPANDED is an advanced therapy medicinal product being studied for the treatment of severe corneal ulcers[1]. This innovative treatment is also known by other names, including:

  • NANOULCOR
  • Nanostructured fibrin-agarose artificial cornea model
  • Human nanostructured artificial cornea

This treatment is a type of living tissue equivalent, which means it’s designed to mimic and replace damaged corneal tissue[1].

How does it work?

This treatment works by using specially prepared cells to help regenerate damaged corneal tissue. It combines two types of cells[1]:

  1. Allogenic sclerocorneal limbus stem-derived adult limbal cells: These are stem cells taken from the limbus (the border between the cornea and the white part of the eye) of a donor. They are grown (expanded) in a laboratory.
  2. Allogenic corneal-derived adult keratocytes: These are cells from the cornea of a donor, also expanded in the lab.

These cells are combined with a special biological matrix to create a living tissue equivalent that can be implanted into the patient’s eye[1]. The goal is for this artificial cornea to integrate with the patient’s own tissue and help heal severe corneal damage.

What conditions does it treat?

This treatment is being studied for patients with severe corneal ulcers that haven’t responded to conventional treatments. Specifically, it may help with[2]:

  • Corneal trophic ulcers: These are persistent sores on the cornea that don’t heal properly.
  • Sequelae of previous ulcers: This refers to complications or after-effects of past corneal ulcers, such as:
    • Stromal thinning (thinning of the middle layer of the cornea)
    • Corneal fibrosis (scarring)
  • These conditions may or may not be associated with limbal insufficiency (a lack of stem cells in the limbus) in the affected eye.

Current clinical trials

There are currently two clinical trials studying this treatment[1][2]:

  1. A Phase IIb trial called NANOULCOR, which aims to evaluate the clinical efficacy of the treatment in patients with severe corneal ulcers.
  2. A multicenter trial to assess the safety, feasibility, and evidence of clinical efficacy in patients with advanced corneal trophic ulcers that haven’t responded to conventional treatments.

Potential benefits

The researchers are hoping this treatment will provide several benefits for patients[1][2]:

  • Regeneration of the damaged corneal tissue
  • Reduction in healing time for corneal ulcers
  • Improvement in visual acuity (sharpness of vision)
  • Reduction in corneal complications
  • Improvement in the patient’s quality of life

Who is eligible for this treatment?

While the exact eligibility criteria may vary between clinical 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 corneal thinning, clouding, or other sequelae from previous severe ulcers
  • Those with corneal damage that doesn’t extend to the deepest layer (Descemet’s membrane)

However, patients with certain conditions may not be eligible, including those with[1][2]:

  • Active eye infections
  • Certain systemic diseases or infections
  • Pregnancy or breastfeeding
  • Recent participation in other clinical trials

Safety considerations

As with any new treatment, safety is a primary concern. The clinical trials are designed to carefully monitor for any adverse effects. Some key safety aspects being evaluated include[2]:

  • The occurrence of adverse events and severe adverse events related to the treatment
  • The condition of the implanted artificial cornea (whether it maintains its integrity, survives, or is reabsorbed)
  • Any signs of local, regional, or systemic infection
  • The development of new blood vessels in the cornea (induced corneal vascularization)

It’s important to note that this treatment is still in the clinical trial phase. More research is needed to fully understand its effectiveness and long-term safety profile.

Aspect Details
Treatment Allogenic Sclerocorneal Limbus Stem-Derived Adult Limbal Cells and Allogenic Corneal-Derived Adult Keratocytes, Ex-Vivo Expanded
Administration Implantation of nanostructured artificial cornea
Target Condition Severe corneal ulcers refractory to conventional treatment
Primary Objectives Evaluate safety, feasibility, and clinical efficacy
Key Inclusion Criteria Adults with severe corneal ulcers, disease duration ≥3-6 weeks, no active ocular infection
Key Exclusion Criteria Pregnancy, active neoplasia, recent participation in other clinical trials
Primary Endpoints Adverse events, graft conditions, infection signs, corneal vascularization
Secondary Endpoints Corneal regeneration, visual acuity, quality of life, corneal surface characterization

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 made from allogenic stem cells in treating severe corneal ulcers that have not responded to conventional treatments.
  • Who can participate in these clinical trials? Participants must be adults (18 years or older) with severe corneal ulcers that have not responded to conventional treatments for at least 3-6 weeks. They must not have active ocular infections, and meet specific health criteria. Pregnant or breastfeeding women are typically excluded.
  • What is the treatment being tested? The treatment being tested is a nanostructured artificial cornea made from Allogenic Sclerocorneal Limbus Stem-Derived Adult Limbal Cells and Allogenic Corneal-Derived Adult Keratocytes, which are expanded ex-vivo and combined with a biological matrix.
  • How is the treatment administered? The treatment is administered through implantation of the artificial cornea onto the patient's damaged cornea.
  • What are the main outcomes being measured in these trials? The main outcomes being measured include the safety of the treatment (incidence of adverse events), the ability of the artificial cornea to regenerate the damaged corneal tissue, improvements in visual acuity, and changes in the patient's quality of life.

Ongoing Clinical Trials on Allogenic Sclerocorneal Limbus Stem-Derived Adult Limbal Cells, 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

  • Allogenic: Cells or tissues that are genetically different from the recipient but come from the same species.
  • Sclerocorneal Limbus: The border area between the cornea (the clear front part of the eye) and the sclera (the white of the eye), which contains stem cells important for corneal health.
  • Ex-Vivo Expanded: Cells that have been grown and multiplied outside the body in a laboratory setting.
  • Keratocytes: Specialized cells found in the cornea that help maintain its structure and transparency.
  • Nanostructured: Materials or structures engineered at the nanoscale (extremely small) level to enhance their properties or functions.
  • Corneal Ulcer: An open sore or erosion on the surface of the cornea, often caused by infection or injury.
  • Trophic Defect: A problem with the nutrition or maintenance of tissues, in this case, referring to issues with the cornea's ability to heal and maintain itself.
  • Stromal Involvement: Affecting the stroma, which is the main structural layer of the cornea.
  • Descemet's Membrane: A thin, strong layer of tissue that lies between the stroma and the innermost layer of the cornea.
  • Bullous Keratopathy: A condition where the cornea becomes permanently swollen, leading to poor vision and pain.

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/