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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)

Study acronym: STROMCOL3D
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07440186
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Collaborators: Instituto de Investigación Hospital Universitario La Paz, Instituto de Investigación Sanitaria Gregorio Marañón
Conditions
(from sponsor)		 Patients With Severe Corneal Melting
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov