ALLOGENIC SCLEROCORNEAL LIMBUS STEM-DERIVED ADULT LIMBAL CELLS, EX-VIVO EXPANDED; ALLOGENIC CORNEAL-DERIVED ADULT KERATOCYTES, EX-VIVO EXPANDED for Corneal trophic ulcer | Corneal stromal thinning | Corneal fibrosis

Inclusion criteria

• {"criterion_text":"- Patients that give their informed consent for study participation.\n- Stage 3 Mackie corneal ulcers that do not respond to conventional medical treatment, and may also be secondary to any of the following causes: Riley-Day syndrome (familial dysautonomia), Goldenhar-Gorlin syndrome, Mobius syndrome, Corneal hypoesthesia family, Diabetes, Multiple sclerosis, Leprosy, Hypovitaminosis A, Autoimmune disorders, Acoustic neuroma, Meningioma, Neuralgia, Aneurysm, Stroke, Neoplasia, Herpes simplex, Herpes zoster, Caustication, Wound, inflammation, or wearing contact lenses, Cataract surgery or keratoplasty (aggression to ciliary nerves), Abuse of topical anesthetics, Toxicity of timolol, betaxolol, diclofenac sodium or sulfacetamide, Lattice or granular, Orbital neoplasia.\n- Patients having undergone previous stage 3 Mackie corneal ulcers, currently suffering sequelae such as stromal fibrosis or corneal thinning, having no effective therapeutic alternative.\n- Stromal involvement, not reaching the Descemet membrane. Central or peripheral localization.\n- No active ocular infection.\n- Man or woman aged ≥18, with no upper age limit.\n- Minimum duration of the disease causing the corneal ulcer: 6 weeks.\n- Patients with normal laboratory parameters as defined by: Leukocytes ≥ 3000, Neutrophils ≥ 1500, Platelets ≥ 100000, AST/ALT ≤ 1.5 ULN, Creatinine ≤ 1.5 mg/dL."}

Exclusion criteria

• {"criterion_text":"- Absence of stromal involvement.\n- Good response to standard medical treatments for corneal disease in less than 3 to 5 weeks.\n- Active ocular infection.\n- Bullous keratopathy or other endothelial decompensations.\n- Positive serology to HBV, HCV, HIV or any other pathology that may interfere with correct patient follow-up. In the case of HIV, it is understood that a positive serology implies a positive value in the anti-HIV antibody. In the case of HCV, a serology is considered positive when a positive value is obtained for the anti-HCV antibody. Finally, in the case of HBV, positive serology is interpreted as a positive HBV-antigen value or a positive viral load value (HBV-NAT). The inclusion of the subject will not be ruled out if a positive anti-HBVc core antibody is present and the anti-HBVs immunization levels are high enough to guarantee adequate protection of the patient (anti-HBVs > 100 IU/L).\n- Pregnant or breast-feeding women or childbearing-age women that do not consent the use of contraceptive methods approved in the protocol. Hormonal contraceptive methods that inhibit ovulation (combining estrogens with progestogens or progestogens only) for oral, transdermal, intravaginal, injectable or implantable administration, IUD, surgical sterilization or total abstinence are described as an effective contraceptive method.\n- Medical history of active neoplasia within the past 5 years.\n- Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies."}

Primary endpoints

• {"endpoint_text":"- Incidence of adverse events and severe adverse events related with the IMP.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Graft conditions (artificial cornea): integrity, graft survival or reabsorption.","definition_or_measurement_approach":"Assessment of construct integrity including graft survival or reabsorption (no detailed measurement method specified)."}
• {"endpoint_text":"- Local, regional or systemic infection signs.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Induced corneal vascularization.","definition_or_measurement_approach":"Graded by quadrants and depth (as indicated in translations)."}

Secondary endpoints

• {"endpoint_text":"- Ulcer persistence or regeneration of corneal stroma.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Visual acuity.","definition_or_measurement_approach":"Measured by standard visual acuity assessments (not further specified)."}
• {"endpoint_text":"- Corneal transparency.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life (EQ5, part I and II).","definition_or_measurement_approach":"Measured using EQ-5 questionnaire (parts I and II)."}
• {"endpoint_text":"- Characterization of corneal surface (impression citology & OCT mapping).","definition_or_measurement_approach":"Characterization performed with impression cytology and epithelial mapping using OCT."}

Spain

Earliest CTIS Part Ii Submission Date

24-06-2024

Latest Decision Or Authorization Date

05-07-2024

Processing Time Days

11

Number Of Sites

11

Number Of Participants

20

Primary sponsor

Full Name

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain