BACKGROUND:Autologous bone marrow mononuclear cell (ABMMNC) therapy has shown promise in patients with heart failure (HF). Cell function analysis may be important in interpreting trial results. METHODS: In this prospective study, we evaluated the safety and efficacy of the transendocardial delivery of ABMMNCs in no-option patients with chronic HF. Efficacy was assessed by maximal myocardial oxygen consumption, single photon emission computed tomography, 2-dimensional echocardiography, and quality-of-life assessment (Minnesota Living with Heart Failure and Short Form 36). We also characterized patients' bone marrow cells by flow cytometry, colony-forming unit, and proliferative assays. RESULTS: Cell-treated (n = 20) and control patients (n = 10) were similar at baseline. The procedure was safe; adverse events were similar in both groups. Canadian Cardiovascular Society angina score improved significantly (P = .001) in cell-treated patients, but function was not affected. Quality-of-life scores improved significantly at 6 months (P = .009 Minnesota Living with Heart Failure and P = .002 physical component of Short Form 36) over baseline in cell-treated but not control patients. Single photon emission computed tomography data suggested a trend toward improved perfusion in cell-treated patients. The proportion of fixed defects significantly increased in control (P = .02) but not in treated patients (P = .16). Function of patients' bone marrow mononuclear cells was severely impaired. Stratifying cell results by age showed that younger patients (≤60 years) had significantly more mesenchymal progenitor cells (colony-forming unit fibroblasts) than patients >60 years (20.16 ± 14.6 vs 10.92 ± 7.8, P = .04). Furthermore, cell-treated younger patients had significantly improved maximal myocardial oxygen consumption (15 ± 5.8, 18.6 ± 2.7, and 17 ± 3.7 mL/kg per minute at baseline, 3 months, and 6 months, respectively) compared with similarly aged control patients (14.3 ± 2.5, 13.7 ± 3.7, and 14.6 ± 4.7 mL/kg per minute, P = .04). CONCLUSIONS: ABMMNC therapy is safe and improves symptoms, quality of life, and possibly perfusion in patients with chronic HF.
RCT Entities:
BACKGROUND: Autologous bone marrow mononuclear cell (ABMMNC) therapy has shown promise in patients with heart failure (HF). Cell function analysis may be important in interpreting trial results. METHODS: In this prospective study, we evaluated the safety and efficacy of the transendocardial delivery of ABMMNCs in no-option patients with chronic HF. Efficacy was assessed by maximal myocardial oxygen consumption, single photon emission computed tomography, 2-dimensional echocardiography, and quality-of-life assessment (Minnesota Living with Heart Failure and Short Form 36). We also characterized patients' bone marrow cells by flow cytometry, colony-forming unit, and proliferative assays. RESULTS: Cell-treated (n = 20) and control patients (n = 10) were similar at baseline. The procedure was safe; adverse events were similar in both groups. Canadian Cardiovascular Society angina score improved significantly (P = .001) in cell-treated patients, but function was not affected. Quality-of-life scores improved significantly at 6 months (P = .009 Minnesota Living with Heart Failure and P = .002 physical component of Short Form 36) over baseline in cell-treated but not control patients. Single photon emission computed tomography data suggested a trend toward improved perfusion in cell-treated patients. The proportion of fixed defects significantly increased in control (P = .02) but not in treated patients (P = .16). Function of patients' bone marrow mononuclear cells was severely impaired. Stratifying cell results by age showed that younger patients (≤60 years) had significantly more mesenchymal progenitor cells (colony-forming unit fibroblasts) than patients >60 years (20.16 ± 14.6 vs 10.92 ± 7.8, P = .04). Furthermore, cell-treated younger patients had significantly improved maximal myocardial oxygen consumption (15 ± 5.8, 18.6 ± 2.7, and 17 ± 3.7 mL/kg per minute at baseline, 3 months, and 6 months, respectively) compared with similarly aged control patients (14.3 ± 2.5, 13.7 ± 3.7, and 14.6 ± 4.7 mL/kg per minute, P = .04). CONCLUSIONS: ABMMNC therapy is safe and improves symptoms, quality of life, and possibly perfusion in patients with chronic HF.
Authors: Charles K F Chan; Paul Lindau; Wen Jiang; James Y Chen; Lillian F Zhang; Ching-Cheng Chen; Jun Seita; Debashis Sahoo; Jae-Beom Kim; Andrew Lee; Sujin Park; Divya Nag; Yongquan Gong; Subhash Kulkarni; Cynthia A Luppen; Alexander A Theologis; Derrick C Wan; Anthony DeBoer; Eun Young Seo; Justin D Vincent-Tompkins; Kyle Loh; Graham G Walmsley; Daniel L Kraft; Joseph C Wu; Michael T Longaker; Irving L Weissman Journal: Proc Natl Acad Sci U S A Date: 2013-07-15 Impact factor: 11.205
Authors: Emerson C Perin; James T Willerson; Carl J Pepine; Timothy D Henry; Stephen G Ellis; David X M Zhao; Guilherme V Silva; Dejian Lai; James D Thomas; Marvin W Kronenberg; A Daniel Martin; R David Anderson; Jay H Traverse; Marc S Penn; Saif Anwaruddin; Antonis K Hatzopoulos; Adrian P Gee; Doris A Taylor; Christopher R Cogle; Deirdre Smith; Lynette Westbrook; James Chen; Eileen Handberg; Rachel E Olson; Carrie Geither; Sherry Bowman; Judy Francescon; Sarah Baraniuk; Linda B Piller; Lara M Simpson; Catalin Loghin; David Aguilar; Sara Richman; Claudia Zierold; Judy Bettencourt; Shelly L Sayre; Rachel W Vojvodic; Sonia I Skarlatos; David J Gordon; Ray F Ebert; Minjung Kwak; Lemuel A Moyé; Robert D Simari Journal: JAMA Date: 2012-03-24 Impact factor: 56.272