Transplantation of Autologous Stem Cells for the treatment of corneal diseases

Phase 1

• Conditions: Corneal Diseases; MedDRA version: 20.0Level: PTClassification code 10023353Term: KeratoconusSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-000523-14-ES
• Lead Sponsor: niversidad Miguel Hernandez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-09
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients affected by corneal stromal dystrophies of any type, but particularly keratoconus, showing clear evidence in the ophthalmic examination of the presence and clear expression of the disease and loss of vision as a result of it.
• Age: = 18-60 years.
• Patients with best corrected visual acuity less than 0.6.
• Absence of chronic or recurrent inflammation in the anterior segment and on the ocular surface.
• Patient able to undergo corneal graft surgery with local anesthesia, from the medical point of view.
• Normal Pre-surgical analyses of serum biochemistry and hematology.
• Negative serology for Human Immunodeficiency Virus (HIV), hepatitis B (HBV), and hepatitis C (HCV).
• No history of malignant disease.
• Normal chest X-ray (Rx).
• Normal urine analysis.
• Normal thyroid test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Dense and extensive corneal stromal scars with severe involvement of the visual axis and located in the pupillary area, causing a decrease in the best corrected vision at levels of 0.1 or less.
• Distant vision corrected with glasses of 0.7 or greater.
• Extreme corneal thinning with risk of perforation.
• Infection.
• Previous corneal surgeries.
• Moderate or severe dry eye.
• Moderate or severe chronic inflammatory pathology of the ocular surface.
• Prior ocular surgery other than cataract.
• Presence of a cataract or other severe opacity of the transparent media of the eye that could impede the proper examination of the fundus.
• Other ophthalmic comorbidity such as glaucoma or uveitis or any that requires the chronic use of ocular topical medication.
• Known and severe coagulation abnormalities.
• Any medical condition that may interfere causing serious adverse effects during the study.
• Presence of active or inactive corneal neovascularization (CNV) in the eye to be treated
• Any immunodeficiency or systemic autoimmune disease.
• Any current or intermittent immunosuppressive therapy or low doses of corticosteroids.
• Renal insufficiency, defined by creatine value >1.3 mg / dL.
• Serological evidence of infection due to hepatitis B, hepatitis C or HIV.
• Pregnant or lactating woman.
• Correct visual acuity in the eye contralateral to the experimental smaller than 20/40 (0.5).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified