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Amniotic Membrane, Human

Amniotic membrane, derived from human tissue, is being studied as a potential treatment for patients with advanced corneal ulcers that have not responded to conventional therapies. This innovative approach involves using a nanostructured artificial cornea to address severe corneal diseases for which there are currently limited effective treatments. The clinical trial aims to evaluate the safety, feasibility, and potential clinical efficacy of this groundbreaking technique.

Table of Contents

What is Amniotic Membrane?

Amniotic membrane, also known as human amniotic membrane, is a unique biological material derived from the innermost layer of the placenta[1]. In medical applications, it is used as a living tissue equivalent, which means it can be transplanted into the human body to support healing and tissue regeneration[1].

Medical Conditions Treated

Amniotic membrane is being studied as a potential treatment for several eye conditions, particularly advanced corneal ulcers that have not responded to conventional treatments[1]. These conditions include:

  • Corneal trophic ulcers: These are persistent defects in the cornea (the clear front part of the eye) that don’t heal properly.
  • Stromal thinning: A condition where the middle layer of the cornea becomes thinner.
  • Corneal fibrosis: The formation of scar tissue on the cornea.
  • Limbal insufficiency: A condition where the stem cells at the edge of the cornea are damaged or missing.

These conditions can be associated with various underlying causes, such as genetic disorders, autoimmune diseases, infections, or injuries[1].

How It Works

Amniotic membrane is used as a biological bandage or scaffold for the eye. When applied to the cornea, it can:

  • Promote healing of the corneal surface
  • Reduce inflammation
  • Prevent scarring
  • Support the growth of new, healthy corneal cells

The membrane is typically implanted onto the eye’s surface during a surgical procedure[1].

Clinical Trial Overview

A multicenter clinical trial is being conducted to evaluate the safety and feasibility of using amniotic membrane along with allogeneic stem cells to create a nanostructured artificial human cornea[1]. This innovative approach aims to help patients with severe corneal diseases for which there are currently no effective treatments.

The main objectives of the trial are to:

  1. Assess the safety of the artificial cornea
  2. Evaluate how well the graft integrates and survives
  3. Determine if there’s evidence of clinical effectiveness

Eligibility Criteria

To participate in this clinical trial, patients must meet specific criteria, including:

  • Age 18 or older
  • Having a severe corneal ulcer (Stage 3 Mackie) that hasn’t responded to conventional treatments for at least 6 weeks
  • No active eye infections
  • Normal blood test results

Certain conditions may exclude a person from participating, such as pregnancy, active cancer, or recent participation in other clinical trials[1].

Potential Benefits

If successful, this treatment could offer hope to patients with severe corneal diseases by:

  • Healing persistent corneal ulcers
  • Improving corneal transparency
  • Regenerating damaged corneal tissue
  • Enhancing overall quality of life

Safety Considerations

As with any medical treatment, there are potential risks and safety considerations. The clinical trial will closely monitor for:

  • Adverse events related to the treatment
  • Signs of infection (local, regional, or systemic)
  • Graft rejection or failure
  • Induced corneal vascularization (growth of blood vessels into the cornea)

It’s important to note that this treatment is still in the research phase, and its long-term safety and effectiveness are being evaluated[1].

Aspect Details
Study Type Multicenter clinical trial
Main Objective Evaluate safety, feasibility, and efficacy of human artificial nanostructured lamellar cornea
Target Condition Advanced corneal trophic ulcers refractory to conventional treatment
Key Inclusion Criteria Age ≥18, Stage 3 Mackie corneal ulcers, minimum 6 weeks disease duration
Key Exclusion Criteria Active ocular infection, bullous keratopathy, positive serology for certain diseases
Primary Endpoints Adverse events, graft conditions, infection signs, induced corneal vascularization
Secondary Endpoints Ulcer persistence, corneal transparency, quality of life, corneal surface characterization
Investigational Product Amniotic membrane (human) as living tissue equivalent

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the safety, feasibility, and potential clinical effectiveness of a human artificial nanostructured lamellar cornea in patients with severe corneal disease who currently have no effective treatment options.
  • Who can participate in this clinical trial? Participants must be at least 18 years old with stage 3 Mackie corneal ulcers that haven't responded to conventional medical treatment for at least 6 weeks. They may also have sequelae from previous ulcers, such as stromal fibrosis or corneal thinning.
  • What is an amniotic membrane? An amniotic membrane is a tissue derived from the innermost layer of the placenta. In this trial, it is being used as a living tissue equivalent to create a nanostructured artificial cornea for transplantation.
  • What are the potential benefits of this treatment? The potential benefits include healing of corneal ulcers, regeneration of corneal stroma, improved corneal transparency, and overall better quality of life for patients with severe corneal diseases that haven't responded to other treatments.
  • What are the main things researchers will be monitoring during the trial? Researchers will primarily monitor the incidence of adverse events, the condition of the artificial cornea graft (including its integrity and survival), signs of infection, and any induced corneal vascularization. They will also assess ulcer healing, corneal transparency, and improvements in quality of life.

Ongoing Clinical Trials on Amniotic Membrane, Human

  • 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 trophic ulcer: A type of corneal ulcer that occurs due to poor healing or lack of sensation in the cornea, often resulting from nerve damage or other underlying conditions.
  • Stromal thinning: A condition where the middle layer of the cornea (stroma) becomes thinner, potentially weakening the structure of the eye.
  • Limbal insufficiency: A condition where the stem cells in the limbal area of the eye (the border between the cornea and the white of the eye) are damaged or insufficient, affecting corneal health and repair.
  • Nanostructured artificial cornea: An engineered cornea made using advanced technology to mimic the structure of a natural cornea at a very small (nano) scale.
  • Allogeneic: Referring to tissues or cells that come from a genetically different donor of the same species.
  • Keratoplasty: A surgical procedure to replace part of the cornea with donor corneal tissue.
  • Stromal fibrosis: The formation of excess fibrous connective tissue in the stroma (middle layer) of the cornea, often as a result of injury or inflammation.
  • Descemet membrane: A thin, strong inner layer of the cornea that serves as a protective barrier.
  • Bullous keratopathy: A condition where the cornea swells and forms tiny fluid-filled blisters, often due to endothelial cell dysfunction.
  • Endothelial decompensation: A condition where the innermost layer of the cornea (endothelium) fails to maintain proper fluid balance, leading to corneal swelling and vision problems.

References

  1. http://clinicaltrials.eu/trial/study-on-allogenic-stem-cells-and-amniotic-membrane-for-patients-with-advanced-corneal-ulcers-unresponsive-to-standard-treatment/