Autologous peripheral blood CD133+ cell implantation for limb salvage in patients with critical limb ischemia.
We report the safety and feasibility of autologous CD133+ cell implantation into the lower extremity muscles of patients with critical limb ischemia, whose only other option was limb amputation. Nine patients participated in the study: seven patients suffering from arteriosclerosis obliterans, one with thromboangiitis obliterans (Buerger's disease) and one with thromboembolic disorder. Autologous PBSC were collected after the administration of G-CSF (10 mcg/kg/day). CD133+ cells were selected using the CLINIMACS cell separation device and were injected i.m. without earlier cryopreservation using a 22-gauge needle into multiple sites 3 cm apart in the gastrocnemius/soleus muscle, or depending on clinical circumstances, in the foot or quadriceps muscle, or both, of the involved leg. There were no complications from either leukapheresis or injection. Stem cell injection prevented leg amputation in seven of the nine patients. In this small cohort of patients with end-stage critical limb ischemia, quality of life (Short Form-36) physical component score improved significantly at 3 (P=0.02) and 6 (P=0.01) months, but not at 1 year (P=0.08). There was a trend towards the improvement in pain-free treadmill walking time (P=0.13) and exercise capacity (P=0.16) at 1 year. Lower extremity limb salvage was achieved for seven of the nine treated patients.
Burt
R K
RK
Division of Immunotherapy, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA. rburt@northwestern.edu
Testori
A
A
Oyama
Y
Y
Rodriguez
H E
HE
Yaung
K
K
Villa
M
M
Bucha
J M
JM
Milanetti
F
F
Sheehan
J
J
Rajamannan
N
N
Pearce
W H
WH
D000071916:AC133 Antigen; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015703:Antigens, CD / Q000378:metabolism; D001162:Arteriosclerosis Obliterans / Q000601:surgery; D005260:Female; D006023:Glycoproteins / Q000378:metabolism; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods; D006801:Humans; D007511:Ischemia / Q000601:surgery*; D007866:Leg / Q000098:blood supply* / Q000601:surgery; D007937:Leukapheresis / Q000379:methods; D017708:Leukocyte Transfusion / Q000379:methods*; D007962:Leukocytes / Q000276:immunology; D023821:Limb Salvage / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000378:metabolism; D013919:Thromboangiitis Obliterans / Q000601:surgery; D014182:Transplantation, Autologous
D000071916:AC133 Antigen; D015703:Antigens, CD; D006023:Glycoproteins; C000606023:PROM1 protein, human; D010455:Peptides; D016179:Granulocyte Colony-Stimulating Factor