A Japanese trial involving a world-first stem-cell transplant has improved the vision of three people with significant cornea damage.
The study, published in The Lancet, involved four people, all of whom suffer from limbal stem cell deficiency (LSCD), which causes severe blurring of vision.
Researchers at the Department of Ophthalmology, Osaka University Hospital, grafted corneal epithelial cell sheets derived from human induced pluripotent stem cells (iPSC) on to the ocular surface after the removal of fibrotic tissue that envelops the ocular surface.
“The approach is based on our development of a self-formed, ectodermal, autonomous, multizone (SEAMs) cultivation protocol that effectively produces precursor cells of ocular tissues from human iPSCs,” the researchers said in The Lancet.
“To our knowledge, this is the first use of iPSC-derived corneal epithelial cells in transplant surgery.”
They said the procedure was successful “and well-tolerated two years postoperatively in all four operated eyes”.
There had been no serious safety concerns found in the two years following the procedure.
“All four eyes also showed positive results clinically, with an improvement in the clinical stage of the disease, better visual acuity, and diminished corneal opacification.”
The vision of one patient, a 39-year-old woman with the most severe vision loss of the group, had once worsened after inital improvement. The researchers believe that may have been because of an immunological response to the transplant. None of those involved were given immunosuppressive drugs.
The report said the procedure was “ground-breaking” and partly mimicked whole-eye development.
“From SEAMs we have successfully fabricated functional ocular tissues including conjunctiva and lacrimal gland.
“The SEAM technology also facilitates the generation of human iPSC-derived corneal epithelial cell sheets, which were able to reconstruct the cornea in an experimentally induced animal corneal injury model.”
They said the procedure represented a promising future treatment option for individuals with an LSCD, and they planned to initiate a multi-centre clinical trial to investigate the larger scale efficacy of the treatment.
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