Health
Human vision is restored through stem cell replacement, a breakthrough in regenerative medicine.
Researchers led by Japan's Osaka University have conducted the first human clinical trial to use induced pluripotent stem cell-derived corneal epithelium to treat limbal stem cell deficiency, opening new possibilities for restoring vision. provided sex.
Limbal stem cell deficiency (LSCD) is a severe eye disease that causes loss of function. adult stem cells Infiltration of the fibrous conjunctival tissue at the edge of the cornea into the cornea causes visual impairment. Limbal stem cells normally perform repair functions by differentiating into the corneal epithelium. Without them, the integrity and transparency of the corneal surface is compromised, leading to the accumulation of fibrotic tissue and ultimately vision loss.
Traditional treatments often involve transplantation from the patient's healthy eye or a donor, but these methods come with risks such as immune rejection or require removal of healthy tissue.
“The corneal epithelium derived from induced pluripotent stem cells is transplant surgery: A single-arm, open-label, first-in-human intervention study in Japan.” published in lancetResearchers implemented transplantation of pluripotent stem cell (iPSC)-derived corneal epithelial sheets (iCEPS) as a potential treatment for LSCD.
Four patients with LSCD participated in the study. After removing the fibrotic tissue, the team implanted allogeneic iCEPS into the affected eye. All surgeries were performed without any human leukocyte antigen (HLA) matching. Half of the patients received low doses of cyclosporine (usually used to reduce organ rejection after transplantation), and the other half received no immunosuppressants other than corticosteroids.
No serious adverse events were identified during 2 years of monitoring. Mild adverse events were effectively managed with no lasting effects.
All four patients experienced significant improvement in visual acuity. In three patients, the disease progressed to a less severe classification. One patient who had a more severe underlying disease initially improved to a less severe stage by 32 weeks, but returned to baseline after 1 year. Quality of life ratings were consistent with visual improvement, with 3 of 4 patients reporting improved scores.
Overall, this study demonstrated that iCEPS transplantation not only stabilizes the corneal surface but also restores functional vision and significantly improves the daily life of patients with limbal stem cell deficiency. The beneficial results were more pronounced in patients who received lower doses of cyclosporine, suggesting that the absence of cyclosporine may have caused subclinical immune rejection.
iCEPS were cultured using a method that recapitulates aspects of natural eye development to generate functional corneal cells. This technique not only ensures the structural integrity of the graft, but also reduces immunogenicity, potentially eliminating the need for HLA matching and extensive immunosuppression typically required with conventional grafts. There is.
This successful outcome represents a major therapeutic advance, building on earlier successes in treatment. regenerative medicine while overcoming the limitations of existing LSCD surgical treatments. The Osaka team plans to initiate a larger multicenter clinical trial to further validate the findings and explore the broader applicability of iCEPS implantation.
Detailed information:
Tsuyoshi Soma et al., Induced pluripotent stem cell-derived corneal epithelium for transplant surgery: a single-arm, open-label, first-in-human intervention study in Japan, lancet (2024). DOI: 10.1016/S0140-6736(24)01764-1
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