Exploratory Clinical Research for the Evaluation of Human GMP (Good Manufacturing Practice) Collagen Implants (Humabiologics) in the Treatment of Corneal Melting (RCJ-COL3D-MC-01-2026)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

Participants will be invited to participate in this clinical study because they have a severe corneal melting. An eye disease characterized by the progressive loss of the transparent tissue that covers the eye (the cornea). This condition can cause pain, vision loss, and risk of eye perforation. Furthermore, in some cases, the response to standard treatments is inadequate.

A piece of 3D-printed human collagen will be implanted on the affected surface of the eye in order to reinforce and protect it and prevent its progression to perforation.

The collagen piece is biocompatible, flexible, and transparent, designed to integrate naturally with the eye's tissues. Since it does not require a complete transplant or a human donor at the time of surgery, it reduces the risks of rejection and complications associated with other more invasive techniques.

Eligibility criteria

Qualifiers

Age over 18 years.

Patients who, after receiving detailed information about the design, purpose, risks, and implications of the study, and about their right to withdraw at any time without repercussions, give their informed written consent.

Confirmed diagnosis of severe corneal melting.

Intensive antibiotic, antifungal, or antiviral treatment according to etiology.

Disqualifiers

Pregnancy or breastfeeding.

Refusal to participate in the study.

Presence of active eye infection.

Systemic diseases that may affect healing.

Trial design

Treatments tested in this trial

  • 3D collagen implant printed under GMP conditions.

Treatment groups

4 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Collaborator

Instituto de Investigación Sanitaria Gregorio Marañón

Collaborator