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Treatment of Severe Eye Chemical Burns with Allogeneic Bone Marrow-Derived Mesenchymal Stromal Cells for Patients with Severe Ocular Chemical Burns

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with severe eye chemical burns. A chemical burn to the eye occurs when a harmful substance, such as an acid or alkali, comes into contact with the eye surface, causing damage to the tissues. In severe cases, the burn affects the entire limbus, which is the border between the clear cornea at the front of the eye and the white part of the eye, as well as the conjunctiva, which is the thin membrane covering the white part of the eye. The treatment being studied involves allogeneic bone marrow-derived mesenchymal stromal cells, which are special cells taken from the bone marrow of a donor and prepared in a laboratory. These cells are given as an injection under the conjunctiva, which is the membrane covering the eye. In addition to this main treatment, patients may receive other medications during the study, including fluorescein sodium eye drops used for eye examinations, paracetamol for pain relief, dexamethasone and oxytetracycline eye ointment that combines an anti-inflammatory medicine with an antibiotic, oxybuprocaine hydrochloride eye drops for numbing the eye, midazolam for sedation, propofol for anesthesia, human serum albumin as a protein solution, ibuprofen for pain relief, povidone iodine solution for eye cleaning, and remifentanil hydrochloride for pain control during procedures.

The purpose of this study is to evaluate how well the injection of these donor-derived cells into the area under the conjunctiva works in preserving the eyeball six months after the first injection in patients who have suffered a severe chemical burn to the eye surface in the recent past. The study will focus on patients whose chemical burn occurred within fifteen days before joining the study and whose burn is classified as very severe, affecting the entire border area around the cornea and the conjunctiva.

During the study, patients will receive the cell treatment as an injection under the membrane covering the eye. The study team will monitor the treated eye over time to check whether the cornea, which is the clear front surface of the eye, develops a hole or perforation. They will also examine other aspects of eye health, including the extent of damage to the limbal area where stem cells normally live, the degree of scarring and blood vessel growth on the cornea, signs of inflammation in the eye surface tissues, visual ability, and detailed images of the front part of the eye using specialized scanning technology. Information about any additional treatments needed and any unwanted effects will be collected from medical records and patient assessments throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment and first injection

    After joining the study, your treatment will begin within 15 days of your chemical burn injury.

    Your eye will be examined using a slit lamp, which is a special microscope that allows detailed viewing of the eye's surface.

    A fluorescein test will be performed. This involves placing a special orange dye in your eye to help identify any damaged areas on the surface.

    Your eye will be prepared for injection using povidone iodine 5% solution for cleaning and disinfection.

    You will receive oxybuprocaine hydrochloride eye drops to numb the surface of your eye before the procedure.

    You may receive medications to help you relax and manage pain during the procedure. These may include midazolam given through a vein, propofol given through a vein, or remifentanil hydrochloride given through a vein.

    You will receive an injection under the conjunctiva (the clear tissue covering the white part of your eye) containing 5 million allogeneic bone marrow-derived mesenchymal stromal cells. These are specialized cells from a donor that may help your eye heal. The cells will be mixed in a solution containing salt water and human serum albumin 0.5%.

    After the injection, dexamethasone and oxytetracycline eye ointment will be applied to your eye.

    You may be given pain relief medications by mouth, such as ibuprofen 400 mg tablets or paracetamol 500 mg capsules, as needed.

    If needed, you may receive paracetamol 10 mg per ml through a vein for additional pain control.

  2. Step 2

    Second injection

    Approximately one week after your first injection, you will return for a second treatment.

    The same examination and preparation procedures will be repeated as described in the first injection.

    You will receive a second injection of 5 million mesenchymal stromal cells under the conjunctiva of your affected eye, using the same technique and medications as the first injection.

    The same eye medications and pain relief options will be available as during the first injection.

  3. Step 3

    Third injection

    Approximately two weeks after your first injection, you will return for a third treatment.

    The same examination and preparation procedures will be repeated as described in the first injection.

    You will receive a third injection of 5 million mesenchymal stromal cells under the conjunctiva of your affected eye, using the same technique and medications as the first injection.

    The same eye medications and pain relief options will be available as during the first injection.

  4. Step 4

    Follow-up examinations

    After completing your three injections, you will have regular follow-up visits to monitor your eye's healing.

    During these visits, your eye will be examined using the slit lamp and fluorescein test to check for any damage or perforation of the cornea (the clear front surface of your eye).

    Your doctor will assess the condition of your limbus, which is the border between the clear cornea and the white part of your eye. This area is important for eye surface healing.

    Your vision will be tested using the Snellen scale, which is the standard eye chart used to measure how well you can see.

    An OCT scan of the anterior segment may be performed. This is a non-invasive imaging test that takes detailed pictures of the front part of your eye using light waves.

    A sample of cells from your conjunctiva may be collected using impression cytology. This involves gently pressing a special filter paper against your eye surface to collect cells for analysis.

    Information about any additional treatments you receive for your eye will be recorded from your medical file.

    Any side effects or complications you experience will be documented and assessed.

  5. Step 5

    Final evaluation at six months

    Six months after your first injection, a final comprehensive evaluation will be performed.

    Your doctor will assess whether your eyeball has been preserved without perforation of the cornea.

    All the same examinations described in the follow-up visits will be repeated to evaluate the overall outcome of your treatment.

    The condition of your eye surface, vision, and any complications will be thoroughly documented.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older
  • You have a chemical burn on the surface of one or both eyes, which means your eye has been damaged by a harmful chemical substance
  • At least one of your eyes has a severe burn classified as stage VI, meaning the burn affects the entire edge of the colored part of your eye and the clear covering over the white part of your eye
  • The burn happened no more than 15 days ago before joining the study
  • You have received complete information about the study and have signed a consent form agreeing to take part
  • You are covered by or receive benefits from a social security system

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified for this clinical trial in the available information.
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Investigated drugs

Allogeneic bone marrow mesenchymal stem cells are special cells taken from the bone marrow of a healthy donor. These cells have the ability to help repair damaged tissue and reduce inflammation. In this trial, they are injected under the conjunctiva (the clear tissue covering the white part of the eye) to help treat severe eye burns caused by chemicals. The goal is to help save the eye and promote healing after a serious chemical injury to the eye surface.

What is already known about the treatment

Allogeneic Bone Marrow Mesenchymal Stem Cells – This treatment is administered through subconjunctival injection, which means the cells are injected beneath the conjunctiva, the clear tissue covering the white part of the eye. Currently, this therapy is being investigated in clinical trials as an experimental treatment for severe chemical burns to the eye's surface, specifically for the most serious cases classified as stage VI burns. The stem cells work by using their natural healing properties to reduce inflammation, promote tissue repair, and help preserve damaged eye tissue at the cellular level through their ability to regulate the immune response and release beneficial growth factors. This belongs to the category of regenerative medicine and cellular therapy, representing an advanced approach to treating eye injuries that might otherwise result in loss of the eye.

Investigated diseases

  • Severe Chemical Eye Burn

    A severe chemical eye burn occurs when a harmful chemical substance comes into contact with the eye, causing significant damage to the ocular surface. This type of injury affects the cornea, conjunctiva, and other structures of the eye's front surface. The condition is classified by severity, with stage VI being among the most serious forms according to medical classification systems. As the injury progresses, it can lead to complications such as corneal perforation, where a hole develops in the cornea. The burn causes inflammation and destruction of tissue, potentially affecting the limbal stem cells that are essential for corneal healing. Without proper management, the condition may result in severe scarring and permanent changes to the eye structure.

  • Limbal Stem Cell Deficiency

    Limbal stem cell deficiency is a condition where the stem cells located at the limbus, the border between the cornea and the white part of the eye, are damaged or destroyed. These stem cells are responsible for continuously renewing the corneal surface and maintaining its clarity. When these cells are lost due to injury, burns, or other causes, the cornea cannot repair itself properly. The conjunctival tissue begins to grow over the cornea, a process called conjunctivalization, leading to clouding and loss of the smooth corneal surface. Patients experience decreased vision and chronic discomfort as the condition progresses. The eye becomes increasingly inflamed and the corneal surface becomes irregular and opaque.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509713-37-00Protocol codeSYMBOL CLINICALEstimated enrolment21 patientsSponsorFondation A De Rothschild

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