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  1. It involves repair or replacement of a defective gene within gamete forming tissues (germ cells).
  2. This produces a heritable change in the genetic constitution of the individual.
  3. Sex cells are more difficult to manipulate genetically than somatic cells, and the risk involved in sex-cell gene therapy are not known.
  4. Clinical trials are performed only on non-human organisms like rats and rabbits as ethical issues are raised.
  5. There are still many technical difficulties in the introduction of genes into germ cells.
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