A groundbreaking study led by Osaka University has conducted the first human trial using stem cell-derived corneal epithelium to treat limbal stem cell deficiency (LSCD).
This pioneering approach could transform the way vision loss is treated and potentially help millions worldwide, including those whose sight has been compromised by diabetes-related complications.
People with diabetes are at a greater risk of developing eye conditions that can lead to blindness, such as diabetic retinopathy and diabetic macular oedema.
Vision loss due to diabetes-related complications is a significant concern, affecting daily life and independence. Diabetic retinopathy is the leading cause of blindness in working-age adults.
The potential of regenerative medicine to restore vision could be life-changing for many, offering a way to repair damage that previously seemed irreversible.
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LSCD is a debilitating eye condition where the cornea loses the adult stem cells responsible for repair and regeneration.
This loss causes fibrotic tissue to invade the corneal surface leading to vision impairment or even blindness.
Normally, limbal stem cells maintain the clarity and health of the cornea by continuously renewing the corneal epithelium.
When these cells are lost or damaged, the eye’s protective surface deteriorates, causing severe vision problems.
Traditional treatments such as grafts from a healthy eye or donor tissue, carry risks like immune rejection and may involve the removal of healthy tissue from other parts of the eye.
In this recent study, published in The Lancet, researchers tested a new treatment using corneal epithelial sheets derived from induced pluripotent stem cells (iPSCs).
The treatment, known as iCEPS (iPSC-derived corneal epithelial sheets), was performed on four patients with LSCD.
After clearing away fibrotic tissue, the iCEPS were transplanted onto the damaged eyes without human leukocyte antigen (HLA) matching.
Half of the patients were given a low dose of cyclosporine to reduce the risk of immune rejection, while the other half received only corticosteroids.
Over two years, the study reported no severe adverse effects. Minor issues were managed effectively, and all patients experienced significant improvements in vision.
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Three of the four patients saw their condition progress to less severe stages, enhancing their quality of life and functional vision. One patient initially improved but experienced a regression after a year, highlighting the need for ongoing research.
The iCEPS used in the trial were developed using techniques that mimic natural eye development creating corneal cells with the necessary functionality to repair the eye.
This method not only improves the structural integrity of the transplanted cells but also reduces the likelihood of immune rejection, eliminating the need for extensive immunosuppressive drugs.
The research shows that using low-dose immunosuppression can further enhance outcomes, as seen in patients who received cyclosporine.
This success represents a major milestone in the field of regenerative medicine, building on previous breakthroughs while overcoming limitations of conventional treatments.
The Osaka research team plans to launch a larger clinical trial to validate these findings and explore wider applications of iCEPS transplantation.
