Endo Tek: Using cultivated donor corneal cells on a hydrogel to treat corneal endothelial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating the safety and feasibility of Endo Tek, a graft made of cultivated human corneal endothelial cells attached to a hydrogel substrate. Participants undergo a surgical procedure to receive the HCEC graft and are followed to monitor safety and preliminary signals of effectiveness. The study compares pre- and post-operative visual acuity, corneal thickness, and endothelial cell density to gauge early efficacy. Eligibility includes adults 21 and older with Fuchs dystrophy or pseudophakic bullous keratopathy, among other criteria. The trial is sponsored by OcuCell with Clinica Quesada as a collaborator, at Clinica Quesada in San Salvador.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥21 years
* Participant or health care agent must understand and sign the informed consent form (ICF)
* Participant must be medically suitable, willing to undergo the surgery and study procedures, and able to attend all follow-up visits
* Phakic or pseudophakia with Fuchs dystrophy or pseudophakic bullous keratopathy

Exclusion Criteria:

* Corneal stromal scarring making standard EK surgery unsuitable at Screening Visit
* Abnormal cornea or anterior segment of eye other than uncomplicated pseudophakia and corneal edema at Screening Visit

Where it's running

• Clinica Quesada
  San Salvador, El Salvador Recruiting

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.