Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment
Multicenter Clinical Trial to Evaluate the Safety and Feasibility of an Allogeneic Tissue Engineered Drug (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers Refractory to Conventional Treatment
2 other identifiers
interventional
16
1 country
11
Brief Summary
This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2014
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2013
CompletedStudy Start
First participant enrolled
January 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2021
CompletedJanuary 20, 2021
January 1, 2021
7 years
January 9, 2013
January 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Adverse events (and serious adverse events) causally related to experimental treatment.
24 months
Implant status (integrity, detachment and reabsorption)
24 months
Local, regional or systemic infections related with the implant
24 months
Induced corneal neovascularization
24 months
Secondary Outcomes (7)
Ulcer persistency or relapse and corneal stromal repair
24 months
Visual acuity
24 months
Corneal transparency
24 months
Tear function (TBUT and Schirmer)
24 months
Quality of life (EQ-5)
24 months
- +2 more secondary outcomes
Study Arms (2)
Anterior lamellar nanostructured artificial human cornea
EXPERIMENTALAnterior lamellar nanostructured artificial human cornea with allogenic from dead donor and cultured in its inside and allogeneic corneal epithelium cultured in its surface
Amniotic membrane transplantation
ACTIVE COMPARATORAmniotic membrane transplantation as conventional treatment of corneal trophic ulcers.
Interventions
Implantation of an anterior lamellar nanostructured artificial human cornea with allogeneic cells from dead donors embedded in a fibrin-agarose scaffold
Implantation of an amniotic membrane graft to cover the corneal scarring using the mixed graft/patch technique.
Eligibility Criteria
You may qualify if:
- Man or woman aged≥18, with no upper age limit.
- Patients that give their informed consent for study participation.
- Stage 3 Mackie corneal ulcers that do not respond to conventional medical treatment, or patients having undergone previous stage 3 Mackie corneal ulcers,33 currently suffering sequelae such as stromal fibrosis or corneal thinning, having no effective therapeutic alternative.
- Stromal involvement, not reaching the Descemet membrane. Central or peripheral localization.
- Minimum duration of the disease causing the corneal ulcer: 6 weeks.
- No active ocular infection.
- Patients with normal laboratory parameters as defined by: Leukocytes≥3000 cells/µL; Neutrophils≥1500 cells/µL; Platelets≥100 billion/L; AST/ALT≤1.5 ULN; Creatinine≤1.5 mg/dL.
You may not qualify if:
- Absence of stromal involvement.
- Good response to standard medical treatments for corneal disease in less than 3 to 5 weeks.
- Bullous keratopathy or other endothelial decompensations.
- Active ocular infection.
- Positive serology to HBV, HCV, HIV or any other pathology that may interfere with correct patient follow-up.
- Pregnant or breast-feeding women or childbearing-age women that do not consent the use of contraceptive methods approved in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Hospital San Juan de Dios
Bormujos, Spain
University Hospital Puerta del Mar
Cadiz, 11009, Spain
Hospital la Arruzafa
Córdoba, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
University Hospital San Cecilio
Granada, 18012, Spain
University Hospital Virgen de las Nieves
Granada, 18014, Spain
Hospital Costa del Sol
Marbella, Spain
Marina Rodriguez Calvo-Mora
Málaga, Spain
University Hospital Virgen Macarena
Seville, 41009, Spain
University Hospital Virgen de Rocío
Seville, 41013, Spain
Hospital Nuestra Señora de Valme
Seville, Spain
Related Publications (1)
Gonzalez-Andrades M, Mata R, Gonzalez-Gallardo MDC, Medialdea S, Arias-Santiago S, Martinez-Atienza J, Ruiz-Garcia A, Perez-Fajardo L, Lizana-Moreno A, Garzon I, Campos A, Alaminos M, Carmona G, Cuende N. A study protocol for a multicentre randomised clinical trial evaluating the safety and feasibility of a bioengineered human allogeneic nanostructured anterior cornea in patients with advanced corneal trophic ulcers refractory to conventional treatment. BMJ Open. 2017 Sep 24;7(9):e016487. doi: 10.1136/bmjopen-2017-016487.
PMID: 28947445BACKGROUND
Study Officials
- STUDY DIRECTOR
Santiago Medialdea, MD, PhD
Hospital U Virgen de las Nieves
- STUDY CHAIR
Miguel Alaminos, MD, PhD
Universidad de Granada
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 10, 2013
Study Start
January 17, 2014
Primary Completion
January 14, 2021
Study Completion
January 14, 2021
Last Updated
January 20, 2021
Record last verified: 2021-01