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Mutations in a cell line stops stem-cell trial to cure blindness

Mutations in a cell line stops stem-cell trial to cure blindness

Publish date: 2015-08-12

Induced pluripotent stem cells (iPSC) turned into specialized retinal cells were meant to cure the damage caused by age-related macular degeneration leading to blindness. The trial was halted due to mutations identified in cells of a second patient.

Tags: clinical trials , stem cells , mutations , macular degeneration , blindness , iPSC

iPSC of non-embryonic origin are derived from mature, differentiated cells reprogrammed to a state of pluripotency, which then can be again differentiated to virtually any type of specialized cells. Such cells was developed by the team of clinical researcher Dr. Masayo Takahashi in Japan. Human retinal epithelium sheet were derived from patient’s own skin cells and would serve as an autogenic transplant.

After a successful transplantation in a first patient in 2014, a trial was recently suspended before transplanting cells into a second patient’s eye. The reason is that their iPSC did not pass the genomic validation step, revealing six mutations in a cell line – three gene deletions and three single nucleotide mutation, one within an oncogene. Mutations could exist in original skin cells at undetectable level or could be acquired during iPSC reprogramming procedure.

Since the risk of carcinogenesis related to oncogene mutation was assessed low, and stem cells specialists presented different view of an overall danger related to the therapy, a trail was suspended for a time being. An additional reason for halting is a change in Japan’s regulation concerning types of institution can run stem-cell trials. After accommodating these changes, the team would introduce attempts to resume a research, thus an identification of the source of mutations, and on the other hand, testing mutation-free skin cells from younger donors for an allogeneic transplantation.

Source: New Scientist

Monika Kossakowska-Zwierucho

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