Yongquan Gu1,2, Lianrui Guo3,4, Jianming Guo3,4, Alan Dardik5, Shuwen Zhang3,4, Zhu Tong3,4, Jian Zhang3,4, Zhonghao Wang3,4. 1. Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China - guyq66@sina.com. 2. Institute of Vascular Surgery, Capital Medical University, Beijing, China - guyq66@sina.com. 3. Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China. 4. Institute of Vascular Surgery, Capital Medical University, Beijing, China. 5. Interdepartmental Program in Vascular Biology and Therapeutics, Yale University School of Medicine, New Haven, CT, USA.
Abstract
BACKGROUND: The safety and efficacy of autologous bone marrow-derived mononuclear cell (BM-MNC) transplantation in the treatment of lower limb ischemia is becoming established, although common treatment protocols are not yet agreed upon. We hypothesized that bone marrow mobilization with granulocyte colony-stimulating factor (G-CSF) improves the safety and effectiveness of cellular therapy. METHODS:Forty-four patients were randomly assigned to receive two injections of G-CSF (300 µg) prior to BM-MNC transplantation. BM-MNC were harvested from all patients and injected as equal aliquots of at least 108 cells into the ischemic leg muscles below the lowest patent artery. RESULTS: After 3 months, patients receiving G-CSF reported increased subjective relief of symptoms and showed increased transcutaneous oxygen tension (TcPO2). After 6 months, patients showed greater improvement in TcPO2, ankle-brachial index, and angiographic score compared to control patients. There were no increased numbers of side effects in patients receiving G-CSF. CONCLUSIONS: G-CSF is safe and effective to mobilize BM-MNC and may allow reduced volume of aspirated bone marrow, potentially reducing procedural complications. G-CSF should be considered for use in patients that are candidates for angiogenic therapy. G-CSF may increase the number of patients that are candidates for therapeutic angiogenesis.
RCT Entities:
BACKGROUND: The safety and efficacy of autologous bone marrow-derived mononuclear cell (BM-MNC) transplantation in the treatment of lower limb ischemia is becoming established, although common treatment protocols are not yet agreed upon. We hypothesized that bone marrow mobilization with granulocyte colony-stimulating factor (G-CSF) improves the safety and effectiveness of cellular therapy. METHODS: Forty-four patients were randomly assigned to receive two injections of G-CSF (300 µg) prior to BM-MNC transplantation. BM-MNC were harvested from all patients and injected as equal aliquots of at least 108 cells into the ischemic leg muscles below the lowest patent artery. RESULTS: After 3 months, patients receiving G-CSF reported increased subjective relief of symptoms and showed increased transcutaneous oxygen tension (TcPO2). After 6 months, patients showed greater improvement in TcPO2, ankle-brachial index, and angiographic score compared to control patients. There were no increased numbers of side effects in patients receiving G-CSF. CONCLUSIONS:G-CSF is safe and effective to mobilize BM-MNC and may allow reduced volume of aspirated bone marrow, potentially reducing procedural complications. G-CSF should be considered for use in patients that are candidates for angiogenic therapy. G-CSF may increase the number of patients that are candidates for therapeutic angiogenesis.
Authors: S Fadilah Abdul Wahid; Nor Azimah Ismail; Wan Fariza Wan Jamaludin; Nor Asiah Muhamad; Muhammad Khairul Azaham Abdul Hamid; Hanafiah Harunarashid; Nai Ming Lai Journal: Cochrane Database Syst Rev Date: 2018-08-29