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Moreover, being able to investigate heteroplasmy at the level of single cells is important, as 50% bulk heteroplasmy may arise from two extreme scenarios: either (1) each cell in the population is approximately 50% heteroplasmic, or (2) one-half of the cells contain 100% wild-type mtDNA, whereas the other half contains 100% mutant mtDNA

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As these nanoformulations progress toward clinical translation, this review also addresses the regulatory challenges associated with their development and proposes potential solutions