CALEC Cell Therapy Repairs Corned damage in Phase 1 Study
Researchers headed by a team at Mass Eye and Ear, Harvard Medical School, reported positive data from a Phase I clinical study evaluating a stem cell treatment known as cultivated autologous limbal epithelial cell transplantation (CALEC), in patients with significant chemical burns in one eye. Results from the study, reported in Science Advances, showed treatment to be safe and well tolerated in four patients who were followed for 12 months. The CALEC recipients experienced restored cornea surfaces.
The Phase I study was designed to determine preliminary safety and feasibility before advancing to a second phase of the trial, and the researchers consider the newly reported early findings to be promising. On the basis of these initial results the team started recruiting for a second phase of the trial that will investigate longer-term safety and efficacy in greater numbers of patients.
The researchers are now finalizing this next phase of the clinical trial in 15 CALEC patients who will be tracked for 18 months to better determine the procedure’s overall efficacy. The hope is that CALEC can one day become a treatment option for patients who previously had to endure long-term deficits when existing treatment options were not an option given the severity of their injuries. “If successful, this first use of CALEC in the United States will serve as a stepping stone for establishing cellular therapy products as viable options for patients with LSCD.”
The CALEC procedure is patent pending, and Jurkunas and Dana have equity in Ocucell, a company interested in developing cell-based therapies for the eye.
https://www.genengnews.com/news/calec-cell-therapy-repairs-corneal-damage-in-phase-i-study/
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