laboratory studies have been performed to check for 
stability, and what is the sensitivity of the analyses? 
(c) What' laboratory evidence is available concerning poten- 
tial harmful effects of the treatment, e.g., development 
of neoplasia, harmful mutations, regeneration of 
infectious particles, or immune responses? Vbat steps 
have been taken in designing the vector to minimize 
pathogenicity? Miat laboratory studies have been 
performed to check for pathogenicity, and what is the 
sensitivity of the analyses? 
(d) Is there evidence from animal studies that vector CNA 
has entered untreated cells, particularly germ line 
cells? V*iat is the sensitivity of the analyses? 
(e) Has a protocol similar to the one proposed for a clin- 
ical trial been carried out in non-human primates and/ 
or other animals? What were the results? Specifically, 
is there any evidence that the retroviral vector has 
reconbined with any endogenous or other viral sequences 
in the animals? 
(2) If a noo-retrcviral delivery system is used: What animal 
studies have been done to determine if there are pathological 
or other undesirable consequences of the protocol (including 
insertion of DNA into cells other than those treated, 
particularly germ line cells)? How long have the animals 
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