A Five-Year Study of the Efficacy of Purified CD34+Cell Therapy for Angiitis-lnduced No-Option Critical Limb Ischemia

作者：Fang, Yuan; Wei, Zheng; Chen, Bin; Pan, Tianyue; Gu, Shiyang; Liu, Peng; Guo, Daqiao; Xu, Xin; Jiang, Junhao; Yang, Jue; Shi, Zhenyu; Zhu, Ting; Shi, Yun; Liu, Yifan; Dong, Zhihui^*; Fu, Weiguo^*

来源：Stem Cells Translational Medicine, 2018, 7(8): 583-590.

DOI：10.1002/sctm.17-0252

• Angiogenesis
• Adult stem cells
• CD34
• Cellular therapy

Angiitis-induced critical limb ischemia (AICLI) patients constitute a remarkable proportion of nooption critical limb ischemia (CLI) patients. Stem cell therapy has become an innovative and promising option for no-option CLI patients. As one of these promising stem cell therapies, purified CD34+ cell transplantation (PuCeT) has shown favorable short-term results. However, the long-term efficacy of PuCeT has yet to be reported. This study evaluates the long-term efficacy of PuCeT in AICLI patients. Twenty-seven AICLI patients were enrolled from May 2009 to December 2011. Granulocyte colony-stimulating factor (G-CSF) and enoxaparin sodium were administered for 5 days. On day 5, CD34+ cell isolation was performed, and cells were transplanted by intramuscular injection. The primary endpoint, major-amputation-free survival rate (MAFS), as well as secondary endpoints, such as peak pain-free walking time (PPFWT) and the Wong-Baker FACES pain rating scale score (WFPRSS), were routinely evaluated during the 5-year follow-up period. The endpoints were as follows: the MAFS was 88.89%; PPFWT increased from 3 +/- 3 to 17 +/- 6 minutes; WFPRSS decreased from 7 +/- 2 to 0.3 +/- 1.7; the ulcer healing rate was 85.71%; the recurrence rate was 11.11%; and SF-36v2 scores were significantly improved at 5 years after PuCeT. The rate of labor recovery 5 years after PuCeT was 65.38%, and no severe adverse effect was observed during the treatment. PuCeT demonstrated long-term efficacy and durability as a treatment of AICLI not only in achieving limb salvage but also in recovering the labor competence and improving the quality of life of patients.

• 出版日期2018-8
• 单位复旦大学