EUCTR2018-000523-14-ES
Active, not recruiting
Phase 1
Transplantation of autologous mesenchymal stem cells of adipose origin for the treatment of corneal diseases
niversidad Miguel Hernandez0 sites30 target enrollmentApril 9, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversidad Miguel Hernandez
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Not specified
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