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

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What is this study about?

This clinical trial is focused on studying a condition known as corneal ulcer, which is a painful open sore on the clear front surface of the eye. The trial is testing a new treatment called NANOULCOR, which is an artificial cornea made from a special combination of cells. These cells include allogenic sclerocorneal limbus stem-derived adult limbal cells and allogenic corneal-derived adult keratocytes, both of which are expanded outside the body and then combined in a biological matrix to form a living tissue equivalent. This treatment is designed to help patients with severe corneal ulcers that do not respond to standard therapies.

The purpose of the study is to evaluate how well NANOULCOR works in healing the corneal ulcers compared to a control group. Participants in the study will receive the treatment through implantation, and the study will monitor the healing process of the corneal ulcers over time. The trial will also look at other factors such as changes in vision, any complications that may arise, and the overall quality of life of the participants. The study will record any side effects and assess the condition of the implanted corneal construct to ensure it remains intact and does not detach or dissolve.

This trial is a Phase IIb study, which means it is in the middle stages of testing the treatment’s effectiveness and safety. It is a randomized, controlled, and unblinded study, meaning participants will be randomly assigned to receive either the new treatment or a control, and both the researchers and participants will know which treatment is being administered. The study is being conducted at multiple centers and aims to provide valuable information on the potential benefits of NANOULCOR for patients with severe corneal ulcers.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current condition to ensure the presence of severe corneal ulcers that have not responded to conventional treatments.

A pregnancy test is required for patients of childbearing age, and informed consent must be provided.

2 treatment preparation

Preparation for the treatment involves scheduling the implantation procedure. The treatment uses a product called alogic sclerocorneal limbus stem adult limbal cells combined with alogic corneal differentiated adult keratocytes in a biological matrix.

This product is a living tissue equivalent and is administered through implantation.

3 implantation procedure

The implantation procedure is performed to introduce the artificial cornea model, known as NANOULCOR, into the affected eye. This procedure aims to regenerate the corneal tissue and address the trophic defect.

4 post-implantation monitoring

Following the implantation, regular follow-up visits are scheduled to monitor the status of the corneal construct. These visits assess the integrity of the implant and check for any detachment or resorption.

The effectiveness of the treatment is evaluated by observing the healing process, changes in visual acuity, and any corneal complications.

5 long-term follow-up

The study includes a six-month follow-up period to ensure the continued effectiveness and safety of the treatment. During this time, patients are required to use safe methods of birth control if applicable.

The primary goal is to determine the capacity of NANOULCOR to regenerate the corneal defect compared to a control group.

Who Can Join the Study?

  • Patients must agree to participate in the study by giving their informed consent.
  • Patients must have trophic corneal ulcers that do not respond to usual medical treatments. These ulcers are caused by specific conditions.
  • Patients who have had this type of corneal ulcer before and now have lasting effects like corneal thinning (thinning of the clear front part of the eye), corneal clouding (cloudiness in the clear front part of the eye), or calcium keratopathy (calcium deposits in the eye).
  • The ulcer may affect the stroma, which is a layer of the cornea, but it should not reach Descemet’s membrane, a deeper layer. The ulcer can be located in the center or on the edges of the cornea.
  • Patients must be over 18 years old, with no upper age limit.
  • The disease causing the corneal ulcer must have lasted for at least 3 weeks.
  • Women of childbearing age must have a negative pregnancy blood test.
  • Both men and women of childbearing age must agree to use safe birth control methods during the study and for six months after.
  • Patients must be willing and able to follow the visit schedule, treatment plan, clinical tests, and all study procedures.

Who Cannot Join the Study?

  • Patients who have any other eye condition that could interfere with the study results.
  • Patients who are currently using any medication that might affect the healing of the eye.
  • Patients who have had eye surgery in the last 3 months.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to any of the ingredients in the study medication.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have a serious illness that could affect their ability to participate in the study.
  • Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hospital Universitario Virgen De Las Nieves Granada Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.11.2023

Trial locations

Investigated drugs:

NANOULCOR is a nanostructured fibrin-agarose artificial cornea model being tested for its effectiveness in treating patients with severe corneal ulcers. This therapy aims to help regenerate the damaged area of the cornea, potentially improving vision and healing the ulcer.

Corneal Ulcer – A corneal ulcer is an open sore on the cornea, the clear front surface of the eye. It often results from infections, injuries, or wearing contact lenses for extended periods. The condition can cause redness, pain, tearing, and blurred vision. As the ulcer progresses, it may lead to a white or gray spot on the cornea. If untreated, it can result in scarring or vision loss. The healing process involves the regeneration of the corneal tissue, which can vary in duration depending on the severity of the ulcer.

Trial ID:
2023-506856-25-00
Protocol code:
FIB-NAN-2023-01
Trial Phase:
Therapeutic exploratory (Phase II)

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