Safety evaluation
BLOOD
All AEs and medical device failures were recorded. The AEs were coded using the Medical Dictionary for Regulatory Activities and classified according to the system organ class and preferred term, as well as severity. Medical device failure was assessed for the magnetic cell sorter and atelocollagen gel.Vital signs, including body temperature, blood pressure, and pulse rate, were checked during the screening (baseline) period and at each time point during the clinical trial. Blood examinations, including hematological and biochemical tests, were undertaken during G-CSF administration and leukapheresis; on the day of surgery (cell transplantation); at 1, 4, 7, and 14 days after the surgery; and at 4, 12, 24, and 52 weeks after the surgery. Human anti-mouse antibodies were tested during the screening period and at 24 weeks after surgery [