Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD) (ADASCs-CT-CD)
Ophthalmological Disorder, Corneal Dystrophy, Treatment
About this trial
This is an interventional treatment trial for Ophthalmological Disorder focused on measuring Regenerative medicine, Corneal bioengineering, Stem cell therapy, Keratoconus, Adipose-derived adult stem cells (ADASCs), Keratocytes, Corneal confocal microscopy, Advanced corneal therapy
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
- 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 suitable to undergo corneal graft surgery under local anesthesia, from a medical point of view.
- Pre-surgical analysis of serum biochemistry and normal hematology.
- Serology for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV) negative.
- No history of malignancy.
- Normal chest x-ray (Rx).
- Normal urinalysis.
- Normal thyroid exam
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 to levels of 0.1 or less.
- Distance corrected vision 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.
- Previous eye surgery other than cataract.
- Presence of cataract or other severe opacity of the transparent media of the eye that could prevent adequate examination of the fundus.
- Other ophthalmic comorbidity such as glaucoma or uveitis or any that requires the chronic use of topical ocular medication.
- Known and severe coagulation abnormalities.
- Any medical condition that may interfere with 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-dose corticosteroids.
- Renal insufficiency, defined by creatine value> 1.3 mg / dL.
- Serological evidence of hepatitis B, hepatitis C, or HIV infection.
- Pregnant or lactating woman.
- Corrected visual acuity in the eye contralateral to the experimental eye less than 20/40 (0.5)
Sites / Locations
- Jorge L. Alio
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
ADASCs Group
Acellular laminas group
ADASCs recellularized laminas group
5 patients, who will receive adipose tissue mesenchymal stem cells in a single dose as study treatment
5 patients, who will receive decellularized corneal laminas as treatment medication
5 patients, who will receive adipose tissue mesenchymal cells combined with decellularized corneal laminas as study treatment in a single intervention