23
Participants
Start Date
August 1, 2016
Primary Completion Date
March 31, 2023
Study Completion Date
March 31, 2023
Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft
Cultivated autologous limbal epithelial cell (CALEC) therapy utilizes a bio-engineered composite of ex vivo expanded autologous corneal epithelial cells and an FDA-approved amniotic membrane (AmnioGraft®, Bio-Tissue, Inc.) to reconstruct the ocular surface. A small biopsy (2-3 mm2) from the patient's contralateral eye serves as a source epithelial (stem) cells that are expanded on the amniotic membrane in culture and the resulting product is surgically transplanted onto the cornea after excision of the fibrovascular pannus.
Cultivation of Limbal epithelial cells into a graft
A graft is manufactured for transplant
CALEC Transplant
Limbal epithelial cells are obtained from the healthy fellow eye and cultivated in a lab for later transplantation into the diseased eye.
Massachusetts Eye and Ear Infirmary, Boston
Dana-Farber Cancer Institute
OTHER
Massachusetts Eye and Ear Infirmary
OTHER