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)

Официальное название

Exploratory Clinical Research for the Evaluation of Human GMP Collagen Implants (Humabiologics) in the Treatment of Corneal Melting.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 3D collagen implant printed under GMP conditions.
  Given its exploratory nature, the study does not propose an equivalence threshold compared to standard treatments, but rather seeks to confirm the safety and clinical viability of the implant. It is expected that 3D-printed collagen will provide superior stromal support, with greater transparency and stability than other reconstructive techniques, such as amniotic membrane, conjunctival flaps, or tectonic grafts.

Первичные конечные точки

• 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. [Срок оценки: During 12 months after the surgery]
• Biocompatibility assessment: potential complications associated with the implant evaluated by slit lamp biomicroscopy [Срок оценки: During 12 months after the surgery]
• Potential complications associated with the implant evaluated by Optical Coherence Tomography (OCT) [Срок оценки: During 12 months after the surgery]

Вторичные конечные точки (10)

• Determine the rate and time of corneal epithelial re-epithelization after implantation [Срок оценки: During 12 months after the surgery]
• Determine the rate and time of corneal epithelial re-epithelialization after implantation [Срок оценки: During 12 months after the surgery]
• Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives) [Срок оценки: During 12 months after the surgery.]
• Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives) [Срок оценки: During 12 months after the surgery]
• Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives) [Срок оценки: During 12 months after the surgery]
• Compare the inflammatory response with conventional treatments (amniotic membrane, conjunctival flap, adhesives) by photograph [Срок оценки: During 12 months after the surgery]
• Quality of life scales: Visual quality and symptom questionnaires: Ocular Surface Disease Index (OSDI) [Срок оценки: 12 months since surgery]
• Quality of life scales: Visual quality and symptom questionnaires: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) [Срок оценки: 12 months since surgery]
• Quality of life scales: Visual quality and symptom questionnaires: Eye pain and discomfort scales [Срок оценки: 12 months since surgery]
• Quality of life scales: Visual quality and symptom questionnaires: Eye pain and discomfort scales: Symptom Likert scale [Срок оценки: 12 months since surgery]

Критерии участия

Критерии включения

• 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.
• 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.

• 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.

Критерии исключения

• Pregnancy or breastfeeding.
• Refusal to participate in the study.
• Presence of active eye infection.
• Systemic diseases that may affect healing.
• Known hypersensitivity to collagen compounds.
• Any circumstance that, in the investigator's opinion, makes the patient's participation in the clinical research inadvisable.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Stokking M, Cadenas-Martín M, Martín-González AI, Fernández-Ferrer A, Arnalich-Montiel F, De Miguel MP. (2025). Three-dimensional-printed collagen scaffold with limbal stem cells derived from adipose-derived mesenchymal stem cells for the treatment of limbal stem cell deficiency. Int J Bioprinting, 11(6), 407-429. doi:10.36922/IJB025290293
• Deshmukh R, Stevenson LJ, Vajpayee R. Management of corneal perforations: An update. Indian J Ophthalmol. 2020 Jan;68(1):7-14. doi: 10.4103/ijo.IJO_1151_19. PMID 31856457
• 10. Koenig KR, et al. "Biomaterials for corneal regeneration: Current perspectives." J Biomed Mater Res. 2020.
• Vajpayee RB, Singhvi A, Sharma N, Sinha R. Penetrating keratoplasty for perforated corneal ulcers: preservation of iris by corneal debulking. Cornea. 2006 Jan;25(1):44-6. doi: 10.1097/01.ico.0000177834.85507.28. PMID 16331040
• Korah S, Selvin SS, Pradhan ZS, Jacob P, Kuriakose T. Tenons Patch Graft in the Management of Large Corneal Perforations. Cornea. 2016 May;35(5):696-9. doi: 10.1097/ICO.0000000000000808. PMID 26989954
• Hick S, Demers PE, Brunette I, La C, Mabon M, Duchesne B. Amniotic membrane transplantation and fibrin glue in the management of corneal ulcers and perforations: a review of 33 cases. Cornea. 2005 May;24(4):369-77. doi: 10.1097/01.ico.0000151547.08113.d1. PMID 15829790
• Solomon A, Meller D, Prabhasawat P, John T, Espana EM, Steuhl KP, Tseng SC. Amniotic membrane grafts for nontraumatic corneal perforations, descemetoceles, and deep ulcers. Ophthalmology. 2002 Apr;109(4):694-703. doi: 10.1016/s0161-6420(01)01032-6. PMID 11927426
• Lee SH, Tseng SC. Amniotic membrane transplantation for persistent epithelial defects with ulceration. Am J Ophthalmol. 1997 Mar;123(3):303-12. doi: 10.1016/s0002-9394(14)70125-4. PMID 9063239

Идентификаторы

NCT: NCT07440186 · RCJ-COL3D-MC-01-2026 · 1500/25/EC-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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