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)

N/ANot Yet RecruitingNCT07440186

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal4 enrolled

Overview

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.

The 3D-printed collagen will be used in clinical research as a biocompatible graft for the treatment of severe corneal melting, providing structural support and promoting epithelial regeneration without the need for more invasive transplants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patients With Severe Corneal Melting

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age over 18 years. 2. 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. 3. Confirmed diagnosis of severe corneal melting. 4. Absence of response to conventional non-surgical treatments, which must include: * Intensive antibiotic, antifungal, or antiviral treatment according to etiology. * Anti-inflammatory or immunomodulatory eye drops (such as corticosteroids, cyclosporine, tacrolimus). * Intensive lubrication and/or autologous serum. * Use of therapeutic contact lenses. * The patient must not have responded satisfactorily to these measures and must show progression or persistence of the ulcer, thinning, and structural risk. The absence of response is not defined by a specific number of treatments, but by the lack of clinical improvement or progression of the condition despite having received several of these measures appropriately. In particular, progression of the epithelial defect, worsening stromal thinning, or the appearance of signs of perforation risk will be considered an absence of response, which would justify surgical intervention. 5. If the patient has previously undergone surgical procedures or received other implants (such as amniotic membrane, conjunctival flap, or Tenon's graft), this will be included if there is documented clinical progression without sufficient functional or structural recovery, and provided that there are no surgical alternatives with documented superior efficacy in their specific situation. Exclusion Criteria: 1. Pregnancy or breastfeeding. 2. Refusal to participate in the study. 3. Presence of active eye infection. 4. Systemic diseases that may affect healing. 5. Known hypersensitivity to collagen compounds. 6. Any circumstance that, in the investigator's opinion, makes the patient's participation in the clinical research inadvisable.

Outcomes

Primary Outcomes

Incidence and severity of adverse reactions to evaluate the safety and biocompatibility of 3D-printed collagen in the corneal stroma of patients with severe corneal melting.

Incidence and severity of adverse reactions (safety and biocompatibility)