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Thromb Haemost 2007; 98(06): 1335-1342
DOI: 10.1160/TH07-02-0137
Cardiovascular Biology and Cell Signalling
Schattauer GmbH

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

Ping Ping Huang
1   Department of Medicine, National Research Center for Stem Cell Engineering & Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China and
,
Xiao Feng Yang
2   Department of Medicine, Research Center for Cell Treatment of the 463 Hospital of the Chinese People‘s Liberation Army, China
,
Shan Zhu Li
1   Department of Medicine, National Research Center for Stem Cell Engineering & Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China and
,
Jin Chao Wen
1   Department of Medicine, National Research Center for Stem Cell Engineering & Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China and
,
Yan Zhang
1   Department of Medicine, National Research Center for Stem Cell Engineering & Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China and
,
Zhong Chao Han
1   Department of Medicine, National Research Center for Stem Cell Engineering & Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China and
› Author AffiliationsFinancial support: This work was supported by grants of 863 (2001AA215311, 2002AA223354) and 973 (001CB5101) projects from the Ministry of Science & Technology of China to ZCH, Fondation Jérme Lejeune, Tianjin Municipal Science and TEchnology Comission (06YFSZSF01300 and 05YFJZIC01500) and National Natural SCience Foundation of China (30570357 and 30600238).
Further Information

Publication History

Received 22 February 2007

Accepted after resubmission 28 October 2007

Publication Date:
30 November 2017 (online)

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Summary

Previous studies have suggested that the lower limb arteriosclerosis obliterans (LASO) could be improved by autologous transplantation of either bone marrow mononuclear cells (BMMNC) 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 BMMNC), 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 BMMNC significantly promotes improvement of limb ischaemia in patients with LASO. Comparative analysis indicated that M-PBMNC should be more practical in comparison with BMMNC in the treatment of LASO.

Keywords

Peripheral vascular disease - angiogenesis - cells - therapy
 

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