Safety evaluation of pUDKH preparation for gene therapy

Bulletin of the Academy of Military Medical Sciences(2006)

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摘要
Objective:To investigate the primary occurrence time,character and degree of toxic reaction in rats after im injection of pUDKH,in order to supply a basis for monitoring toxic reaction and determining primary safety dosage clinically.Methods:The animals were divided into three groups: normal group,pUDKH 0.63 mg/kggroup,and pUDKH(2.50 mg/kg) group,then injected intramuscularly with pUDKH for 14 times,and observed for 16 weeks after discontinuation of drug administration.During the test,the general drug reaction was observed,urine and blood biochemistry was analyzed,the antibody(against) human hepatocyte growth factor(HGF) and the distribution of HGF gene in tissues were examined,and the tissue morphology of main organs was observed.Results:No drug toxic reaction was observed in rats from pUDKH groups,and no significant change was found in urine and serum biochemical examination.High HGF expression was only observed in muscular tissue at the local area of im injection of pUDKH,but wasn′t observedin the other distant tissues(including blood) and no anti-HGF antibody in serum was detected at different time points.In addition,there was no significant change in morphology of local muscle and remote tissues.Conclusion:The dosage of pUDKH injected intramuscularly to rats was 0.63 mg/kgor 2.5 mg/kg,which was 3 or 12.5 times that of the lowest effective pUDKH dosage in rat,respectively.There was no significant change in almost all examinations,suggesting that the dosage less than 2.50 mg/kg was safe under this test conditions,and(pUDKH) gene therapy is safe and feasible for treatment of limb ischemia.
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关键词
pudkh preparation,gene
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