The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Single stem cell expansion in amniotic membrane transplant
IOBA
Valladolid, Valladolid, Spain
Viability and safety of mesenchymal stem cell transplant
Absence of cell metaplasia with phenotype different to corneal or conjunctival as expected, confirmed by corneal impression cytology and in vivo confocal laser ophthalmoscopy
Time frame: 1 Year
Absence of complications in pre and peri surgical implantation
Correct handling and implantation of stem cell with amniotic membrane transplant following an 4 step classification.
Time frame: 1 Week
Improvement of 2 lines in Best Corrected Visual Acuity
Improvement in visual acuity compared to baseline values before transplant
Time frame: 12 month
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