Randomised comparison of G-CSF-mobilized peripheral blood mononuclear cells versus bone marrow-mononuclear cells for the treatment of patients with lower limb arteriosclerosis obliterans.
Previous studies have suggested that the lower limb arteriosclerosis obliterans (LASO) could be improved by autologous transplantation of either bone marrow mononuclear cells (BM-MNC) or G-CSF-mobilized peripheral blood mononuclear cells (M-PBMNC). However, the number of patients observed was very limited, and little information is available regarding comparison. The present randomised trial was designed to assess which is the better option. One hundred fifty patients with LASO were randomised to either group A (76 cases implanted with M-PBMNC) or group B (74 cases implanted with BM-MNC), and followed up for 12 weeks. Primary outcomes were safety and efficacy of treatment, based on ankle-brachial index (ABI) and rest pain, and analysis was per protocol. Significant improvement of the main clinical index was observed in both groups after transplantation. No transplantation-related complication was observed in either group. Comparative analysis revealed that at 12 weeks after cell implantation, improvement of ABI (difference 0.06 +/- 0.01; p < 0.0001), skin temperature (difference 0.55 +/- 0.25; p = 0.028), and rest pain (difference -0.57 +/- -0.15;p < 0.0001) was significantly better in groupA patients than group B patients. However, there was no significant difference between two groups for pain-free walking distance, transcutaneous oxygen pressure, ulcers, and rate of lower limb amputation. Autologous transplantation of either M-PBMNC or BM-MNC significantly promotes improvement of limb ischaemia in patients with LASO. Comparative analysis indicated that M-PBMNC should be more practical in comparison with BM-MNC in the treatment of LASO.
Huang
Ping Ping
PP
Department of Medicine, National Research Center for Stem Cell Engineering & Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology, Tianjin, China.
Yang
Xiao Feng
XF
Li
Shan Zhu
SZ
Wen
Jin Chao
JC
Zhang
Yan
Y
Han
Zhong Chao
ZC
D000368:Aged; D000671:Amputation, Surgical; D000842:Ankle / Q000098:blood supply; D001162:Arteriosclerosis Obliterans / Q000150:complications / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D001785:Blood Gas Monitoring, Transcutaneous; D001794:Blood Pressure; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D001916:Brachial Artery / Q000503:physiopathology; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D019650:Hematopoietic Stem Cell Mobilization / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D007511:Ischemia / Q000209:etiology* / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010147:Pain Measurement; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects; D011446:Prospective Studies; D011994:Recombinant Proteins; D020127:Recovery of Function; D012881:Skin Temperature; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor