Novel stem cell therapy called a CALEC transplant was performed safely in four patients with serious chemical burns tracked in a phase I clinical trial for 12 months. The patients experienced early clinical gains: two were able to undergo a corneal transplant and two reported significant improvements in vision without additional treatment. CALEC procedure takes small amount of stem cells from healthy eye, grows and expands stem cells on a graft, before it is transplanted into the patient's damaged eye.
A team led by researchers from Mass Eye and Ear, a member of Mass General Brigham, reports the results of a phase I trial of a revolutionary stem cell treatment called cultivated autologous limbal epithelial cell transplantation , which was found to be safe and well-tolerated over the short term in four patients with significant chemical burns in one eye.
In CALEC, stem cells from a patient's healthy eye are removed via a small biopsy and then expanded and grown on a graft via an innovative manufacturing process at the Connell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute. After two to three weeks, the CALEC graft is sent back to Mass Eye and Ear and transplanted into the eye with corneal damage.
"It was challenging to develop a process for creating limbal stem cell grafts that would meet the FDA's strict regulatory requirements for tissue engineering," said Ritz, executive director of the Connell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber and professor of medicine at Harvard Medical School.
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