Status:
COMPLETED
Autologous Adipose-Derived Adult Stem Cell Implantation for Corneal Diseases (ADASCs-CT-CD)
Lead Sponsor:
Vissum, Instituto Oftalmológico de Alicante
Collaborating Sponsors:
Universidad Miguel Hernandez de Elche
Instituto de Salud Carlos III
Conditions:
Ophthalmological Disorder
Corneal Dystrophy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
Cellular therapy of the corneal stroma with implantation of mesenchymal stem cells derived from autologous adipose tissue with or without a carrier (scaffold) composed by decellularized human donor co...
Detailed Description
Different types of stem cells have been used in various ways in several research projects to find the optimal procedure to regenerate the human corneal stroma. It included several approaches which can...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05279157
Start Date
April 19 2022
End Date
February 5 2023
Last Update
May 6 2023
Active Locations (1)
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1
Jorge L. Alio
Alicante, Spain, 03016