Clinical trial results…’good effect’ for patients who cannot undergo artificial corneal transplantation due to chemical burns
Enter 2023.08.20 18:10 Hits 303 Enter 2023.08.20 18:10 Edit 2023.08.19 23:01 Hits 303
A woman undergoing an eye exam. An innovative treatment that uses the patient’s own stem cells to restore damaged corneas is yielding good results. [사진=게티이미지뱅크]Clinical trials have shown that patients whose corneas were damaged by severe chemical burns were transplanted with their own stem cells, which improved vision or restored the corneal surface.
A research team at Massachusetts General Hospital, Harvard Medical School, USA, revealed that this was the result of transplanting their own stem cells (cultured autologous limbal epithelial cell transplantation, CALEC) to four patients whose corneas were damaged by chemical burns.
Associate Professor Ulla Yurkunas (ophthalmology) of the research team said, “The results give hope to patients who complain of pain due to vision loss and corneal damage that are difficult to treat.” He added, “The procedure of transplanting the patient’s own stem cells (CALEC) turned out to be safe and well tolerated during the follow-up period.”
The research team conducted a clinical trial (phase 1) of innovative stem cell therapy (CALEC), which was found to be safe and well-tolerated for a short period of time, targeting four patients with severe chemical burns in one eye. As a result of follow-up for 12 months, two patients were able to receive corneal transplantation, and two patients showed significant improvement in visual acuity without receiving separate treatment.
After harvesting stem cells from the patient’s healthy eye, the research team expands and grows the stem cells in the graft using an innovative manufacturing process. Two to three weeks later, the research team transplanted CALEC grafts into the eyes of patients with corneal damage.
Until now, there has been a lack of safe treatments to help patients with severe chemical burns and injuries not eligible for artificial corneal transplants. Patients with chemical burns or eye injuries can develop limbal stem cell deficiency (which results in irreversible loss of cells in the tissue surrounding the cornea). Such patients suffer from permanent vision loss, pain and discomfort. Patients without limbal stem cells and a healthy ocular surface cannot undergo an artificial corneal transplant.
The research team said, “Although the phase 1 clinical trial was designed to confirm safety and feasibility prior to the phase 2 clinical trial, the results are very good.”
The results of this study (Cultivated autologous limbal epithelial cell (CALEC) transplantation: Development of manufacturing process and clinical evaluation of feasibility and safety) were published in the international journal Science Advances.
2023-08-20 09:11:27
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