Researchers at Massachusetts Eye and Ear, a specialty hospital located in Boston, have developed cultivated autologous limbal epithelial cells (CALEC) and it has became the first stem cell therapy for the eye ever trialed in the United States.
The ground-breaking procedure starts by removing stem cells from a healthy eye with a biopsy. Then they are grown for two to three weeks before being surgically transplanted onto an injured cornea.
In a clinical trial, 14 patients with “irreversible” damage to their cornea, or the outermost layer of the eye, saw restoration in the first 18 months.
The patients in the trial could only have one eye that needed treatment because the other healthy eye was used for the biopsy.
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According to a press release from Massachusetts Eye and Ear, when a person suffers a cornea injury, such as a chemical burn, infection, or other trauma, it can deplete the limbal epithelial cells, which can never regenerate.
As a result, the eye sustains permanent surface damage and can’t undergo a corneal transplant, which is the current standard of care for vision rehabilitation. People with these injuries often experience persistent pain and visual difficulties.
“Our first trial in four patients showed that CALEC was safe and the treatment was possible,” said principal investigator Professor Ula Jurkunas. “Now we have this new data supporting that CALEC is more than 90% effective at restoring the cornea’s surface, which makes a meaningful difference in individuals with cornea damage that was considered untreatable.”
According to Massachusetts Eye and Ear, CALEC completely restored the cornea in 50% of participants at their 3-month visit, and that rate of complete success increased to 79% and 77% at their 12- and 18-month visits, respectively.
Two participants met the definition of partial success at 12 and 18 months and the overall success of CALEC was 93% and 92% at 12 and 18 months. Three participants received a second CALEC transplant, one of whom reached complete success by the study end visit.
An additional analysis of CALEC’s impact on vision showed varying levels of improvement in visual acuity in all 14 CALEC patients.
There was only one major adverse affect to the treatment. A bacterial infection occurred in one patient eight months after the implant due to their “chronic” contact lens use.
The CALEC trial is the first human study of a stem cell therapy funded by the National Eye Institute (NEI), which is a part of the National Institutes of Health (NIH). Additionally, it is the first stem cell therapy in the eye in the U.S.
Currently, CALEC remains an experimental procedure and is not offered at Massachusetts Eye and Ear or any U.S. hospital. Additional studies will be needed before the treatment is submitted for federal approval.
“We feel this research warrants additional trials that can help lead towards FDA approval,” said Jurkunas. “While we are proud to have been able to bring a new treatment from the lab bench to clinical trials, our guiding objective was and always will be for patients around the country to have access to this effective treatment.”
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