Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation

Inclusion Criteria: * Subjects with prior decision for amputation above the ankle because of severe PAOD * Males or females above 18 years * Females must be either: * Non pregnant, non lactating , having practicing a medically accepted method of birth control for more than 2 months prior screening visit; * or surgically sterilized (tubal ligation or hysterectomy) * or post menopausal for at least one year Exclusion Criteria: * Subjects with urgent need for amputation that cannot await until completion of the screening period (up to 4 weeks), added to the minimum required 48 hours between study test medication administration and tissue sample collection * Previous or current history of malignant disease (subjects with successful tumor resection more than 5 years -without any recurrence- prior to study start could be enrolled) * Abnormal Chest X-ray or mammography with suspicion of malignant disease * Positive stool hemoccult (except in case of hemorrhoids or any other identified cause with no malignancy origin) * Men with positive Prostate Specific Antigen (PSA) (above 2.5 ng/ml in subjects \< 50 years and above 5 ng/ml in subjects above 50 years) * Females with Papanicolaou smear of Class IV or Class V characterization * Serious concomitant medical conditions not adequately controlled * Alcohol or drug abuse * Active proliferate retinopathy defined by the presence of new vessel formation and scarring * Participation in clinical trials of non-approved experimental agents within four weeks before study entry; * Positive serology for HIV1 or 2 * Creatinine above 2.0 mg/dl (176 µmol/l), unless the subject is on hemodialysis / peritoneal dialysis and diagnosed with complete and irreversible renal failure or end-stage renal disease (ESRD) * Subjects who had a stroke or a neurological deficit presumably due to a stroke, within 3 months prior to study treatment (Amendment #1) * Alpha-fetoprotein (AFP) in serum \> 15 µg/l, unless liver ultrasound ruled out any malignant disease * Positive serology for hepatitis B or C, unless liver ultrasound ruled out any malignant disease. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.