Long-term clinical outcomes for patients with lower limb ischemia implanted with G-CSF-mobilized autologous peripheral blood mononuclear cells.
BACKGROUND
Many studies have described the clinical effects of treating critical limb ischemia with granulocyte colony-stimulating factor-mobilized autologous peripheral blood mononuclear cells (M-PBMNC); however, there are no long-term data available on survival, limb salvage, or prognostic factors.


METHODS
To investigate the long-term clinical outcomes of M-PBMNC implantation, we reviewed data for 162 consecutive patients with limb ischemia who were treated with M-PBMNC implantation at 6 hospitals between 2001 and 2006. A subset of 123 patients with homogenous clinical profiles was selected for prognostic factor analysis.


RESULTS
Of the 162 patients, 50 died during the follow-up period. The median follow-up time for surviving patients was 26.4 months. The 2-year survival rate was 65% for the 140 patients with arteriosclerosis obliterans (ASO), and 100% for the 11, 4 and 7 patients with thromboangiitis obliterans (TAO), diabetic gangrene (DG) and connective tissue disease (CTD), respectively. The 1-year amputation-free rates for ASO, TAO, DG and CTD were 70%, 79%, 75% and 83%, respectively. Common serious adverse events included heart failure (15 cases), myocardial infarction (15 cases), serious infection (13 cases), stroke (10 cases), and malignant tumor (9 cases). Significant negative prognostic factors associated with overall survival were ischemic heart disease and collection of a small number of CD34-positive cells. Factors associated with time-to-amputation and amputation-free survival were a combination of Fontaine classification and lower limb gangrene, and history of dialysis.


CONCLUSIONS
Collection of a small number of CD34-positive cells and ischemic heart disease were associated with a reduction in overall survival.
Horie
Takashi
T
Department of Surgery, Sapporo Hokuyu Hospital, Higashisapporo 6-6, Shiroishi-ku, Sapporo 003-0006, Japan. saiseichiryo@hokuyu-aoth.org
Onodera
Rie
R
Akamastu
Makoto
M
Ichikawa
Yukio
Y
Hoshino
Junichi
J
Kaneko
Eiji
E
Iwashita
Chikara
C
Ishida
Akaru
A
Tsukamoto
Tatsuo
T
Teramukai
Satoshi
S
Fukushima
Masanori
M
Kawamura
Akio
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018952:Antigens, CD34 / Q000096:biosynthesis; D001162:Arteriosclerosis Obliterans / Q000401:mortality / Q000601:surgery; D017690:Cell Transplantation; D003240:Connective Tissue Diseases / Q000401:mortality / Q000601:surgery; D048909:Diabetes Complications / Q000401:mortality / Q000601:surgery; D005260:Female; D005734:Gangrene / Q000401:mortality / Q000601:surgery; D016179:Granulocyte Colony-Stimulating Factor / Q000378:metabolism*; D006801:Humans; D007511:Ischemia / Q000401:mortality / Q000601:surgery*; D007963:Leukocytes, Mononuclear / Q000378:metabolism*; D035002:Lower Extremity / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D013919:Thromboangiitis Obliterans / Q000401:mortality / Q000601:surgery; D016896:Treatment Outcome
D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor