Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)

Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Bassetti, Beatrice [verfasserIn] Carbucicchio, Corrado Catto, Valentina Gambini, Elisa Rurali, Erica Bestetti, Alberto Gaipa, Giuseppe Belotti, Daniela Celeste, Fabrizio Parma, Matteo Righetti, Stefano Biava, Lorenza Arosio, Maurizio Bonomi, Alice Agostoni, Piergiuseppe Scacciatella, Paolo Achilli, Felice Pompilio, Giulio

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Anmerkung:	© The Author(s). 2018

Übergeordnetes Werk:	Enthalten in: Stem cell research & therapy - London : BioMed Central, 2010, 9(2018), 1 vom: 14. Sept.
Übergeordnetes Werk:	volume:9 ; year:2018 ; number:1 ; day:14 ; month:09

Links:	Volltext

DOI / URN:	10.1186/s13287-018-0969-z

Katalog-ID:	SPR031225756

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520			\|a Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014.
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allfields	10.1186/s13287-018-0969-z doi (DE-627)SPR031225756 (SPR)s13287-018-0969-z-e DE-627 ger DE-627 rakwb eng Bassetti, Beatrice verfasserin aut Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO) 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. Carbucicchio, Corrado aut Catto, Valentina aut Gambini, Elisa aut Rurali, Erica aut Bestetti, Alberto aut Gaipa, Giuseppe aut Belotti, Daniela aut Celeste, Fabrizio aut Parma, Matteo aut Righetti, Stefano aut Biava, Lorenza aut Arosio, Maurizio aut Bonomi, Alice aut Agostoni, Piergiuseppe aut Scacciatella, Paolo aut Achilli, Felice aut Pompilio, Giulio (orcid)0000-0003-2581-5735 aut Enthalten in Stem cell research & therapy London : BioMed Central, 2010 9(2018), 1 vom: 14. Sept. (DE-627)624251047 (DE-600)2548671-8 1757-6512 nnns volume:9 year:2018 number:1 day:14 month:09 https://dx.doi.org/10.1186/s13287-018-0969-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2018 1 14 09
spelling	10.1186/s13287-018-0969-z doi (DE-627)SPR031225756 (SPR)s13287-018-0969-z-e DE-627 ger DE-627 rakwb eng Bassetti, Beatrice verfasserin aut Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO) 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. Carbucicchio, Corrado aut Catto, Valentina aut Gambini, Elisa aut Rurali, Erica aut Bestetti, Alberto aut Gaipa, Giuseppe aut Belotti, Daniela aut Celeste, Fabrizio aut Parma, Matteo aut Righetti, Stefano aut Biava, Lorenza aut Arosio, Maurizio aut Bonomi, Alice aut Agostoni, Piergiuseppe aut Scacciatella, Paolo aut Achilli, Felice aut Pompilio, Giulio (orcid)0000-0003-2581-5735 aut Enthalten in Stem cell research & therapy London : BioMed Central, 2010 9(2018), 1 vom: 14. Sept. (DE-627)624251047 (DE-600)2548671-8 1757-6512 nnns volume:9 year:2018 number:1 day:14 month:09 https://dx.doi.org/10.1186/s13287-018-0969-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2018 1 14 09
allfields_unstemmed	10.1186/s13287-018-0969-z doi (DE-627)SPR031225756 (SPR)s13287-018-0969-z-e DE-627 ger DE-627 rakwb eng Bassetti, Beatrice verfasserin aut Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO) 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. Carbucicchio, Corrado aut Catto, Valentina aut Gambini, Elisa aut Rurali, Erica aut Bestetti, Alberto aut Gaipa, Giuseppe aut Belotti, Daniela aut Celeste, Fabrizio aut Parma, Matteo aut Righetti, Stefano aut Biava, Lorenza aut Arosio, Maurizio aut Bonomi, Alice aut Agostoni, Piergiuseppe aut Scacciatella, Paolo aut Achilli, Felice aut Pompilio, Giulio (orcid)0000-0003-2581-5735 aut Enthalten in Stem cell research & therapy London : BioMed Central, 2010 9(2018), 1 vom: 14. Sept. (DE-627)624251047 (DE-600)2548671-8 1757-6512 nnns volume:9 year:2018 number:1 day:14 month:09 https://dx.doi.org/10.1186/s13287-018-0969-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2018 1 14 09
allfieldsGer	10.1186/s13287-018-0969-z doi (DE-627)SPR031225756 (SPR)s13287-018-0969-z-e DE-627 ger DE-627 rakwb eng Bassetti, Beatrice verfasserin aut Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO) 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. Carbucicchio, Corrado aut Catto, Valentina aut Gambini, Elisa aut Rurali, Erica aut Bestetti, Alberto aut Gaipa, Giuseppe aut Belotti, Daniela aut Celeste, Fabrizio aut Parma, Matteo aut Righetti, Stefano aut Biava, Lorenza aut Arosio, Maurizio aut Bonomi, Alice aut Agostoni, Piergiuseppe aut Scacciatella, Paolo aut Achilli, Felice aut Pompilio, Giulio (orcid)0000-0003-2581-5735 aut Enthalten in Stem cell research & therapy London : BioMed Central, 2010 9(2018), 1 vom: 14. Sept. (DE-627)624251047 (DE-600)2548671-8 1757-6512 nnns volume:9 year:2018 number:1 day:14 month:09 https://dx.doi.org/10.1186/s13287-018-0969-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2018 1 14 09
allfieldsSound	10.1186/s13287-018-0969-z doi (DE-627)SPR031225756 (SPR)s13287-018-0969-z-e DE-627 ger DE-627 rakwb eng Bassetti, Beatrice verfasserin aut Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO) 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. Carbucicchio, Corrado aut Catto, Valentina aut Gambini, Elisa aut Rurali, Erica aut Bestetti, Alberto aut Gaipa, Giuseppe aut Belotti, Daniela aut Celeste, Fabrizio aut Parma, Matteo aut Righetti, Stefano aut Biava, Lorenza aut Arosio, Maurizio aut Bonomi, Alice aut Agostoni, Piergiuseppe aut Scacciatella, Paolo aut Achilli, Felice aut Pompilio, Giulio (orcid)0000-0003-2581-5735 aut Enthalten in Stem cell research & therapy London : BioMed Central, 2010 9(2018), 1 vom: 14. Sept. (DE-627)624251047 (DE-600)2548671-8 1757-6512 nnns volume:9 year:2018 number:1 day:14 month:09 https://dx.doi.org/10.1186/s13287-018-0969-z kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 9 2018 1 14 09
language	English
source	Enthalten in Stem cell research & therapy 9(2018), 1 vom: 14. Sept. volume:9 year:2018 number:1 day:14 month:09
sourceStr	Enthalten in Stem cell research & therapy 9(2018), 1 vom: 14. Sept. volume:9 year:2018 number:1 day:14 month:09
format_phy_str_mv	Article
institution	findex.gbv.de
isfreeaccess_bool	true
container_title	Stem cell research & therapy
authorswithroles_txt_mv	Bassetti, Beatrice @@aut@@ Carbucicchio, Corrado @@aut@@ Catto, Valentina @@aut@@ Gambini, Elisa @@aut@@ Rurali, Erica @@aut@@ Bestetti, Alberto @@aut@@ Gaipa, Giuseppe @@aut@@ Belotti, Daniela @@aut@@ Celeste, Fabrizio @@aut@@ Parma, Matteo @@aut@@ Righetti, Stefano @@aut@@ Biava, Lorenza @@aut@@ Arosio, Maurizio @@aut@@ Bonomi, Alice @@aut@@ Agostoni, Piergiuseppe @@aut@@ Scacciatella, Paolo @@aut@@ Achilli, Felice @@aut@@ Pompilio, Giulio @@aut@@
publishDateDaySort_date	2018-09-14T00:00:00Z
hierarchy_top_id	624251047
id	SPR031225756
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR031225756</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519200121.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2018 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13287-018-0969-z</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR031225756</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13287-018-0969-z-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Bassetti, Beatrice</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2018</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s). 2018</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. 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author	Bassetti, Beatrice
spellingShingle	Bassetti, Beatrice Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)
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topic_title	Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)
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title	Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)
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title_full	Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)
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author_browse	Bassetti, Beatrice Carbucicchio, Corrado Catto, Valentina Gambini, Elisa Rurali, Erica Bestetti, Alberto Gaipa, Giuseppe Belotti, Daniela Celeste, Fabrizio Parma, Matteo Righetti, Stefano Biava, Lorenza Arosio, Maurizio Bonomi, Alice Agostoni, Piergiuseppe Scacciatella, Paolo Achilli, Felice Pompilio, Giulio
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title_sort	linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ cd133^{+} $ cells in ischemic refractory cardiomyopathy trial (recardio)
title_auth	Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)
abstract	Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. © The Author(s). 2018
abstractGer	Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. © The Author(s). 2018
abstract_unstemmed	Background Cell therapy with bone marrow (BM)-derived progenitors has emerged as a promising therapeutic for refractory angina (RA) patients. In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. Registered 11 February 2014. © The Author(s). 2018
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title_short	Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)
url	https://dx.doi.org/10.1186/s13287-018-0969-z
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In the present study, we evaluated the safety and preliminary efficacy of transcatheter delivery of autologous BM-derived advanced therapy medicinal product $ CD133^{+} $ cells (ATMP-CD133) in RA patients, correlating perfusion outcome with cell function. Methods In the phase I “Endocavitary Injection of Bone Marrow Derived $ CD133^{+} $ Cells in Ischemic Refractory Cardiomyopathy” (RECARDIO) trial, a total of 10 patients with left ventricular (LV) dysfunction (ejection fraction ≤ 45%) and evidence of reversible ischemia, as assessed by single-photon emission computed tomography (SPECT), underwent BM aspiration and fluoroscopy-based percutaneous endomyocardial delivery of ATMP-CD133. Patients were evaluated at 6 and 12 months for safety and preliminary efficacy endpoints. ATMP-CD133 samples were used for in vitro correlations. Results Patients were treated safely with a mean number of 6.57 ± 3.45 × $ 10^{6} $ ATMP-CD133. At 6-month follow-up, myocardial perfusion at SPECT was significantly ameliorated in terms of changes in summed stress (from 18.2 ± 8.6 to 13.8 ± 7.8, p = 0.05) and difference scores (from 12.0 ± 5.3 to 6.1 ± 4.0, p = 0.02) and number of segments with inducible ischemia (from 7.3 ± 2.2 to 4.0 ± 2.7, p = 0.003). Similarly, Canadian Cardiovascular Society and New York Heart Association classes significantly improved at follow-up vs baseline (p ≤ 0.001 and p = 0.007, respectively). Changes in summed stress score changes positively correlated with ATMP-CD133 release of proangiogenic cytokines HGF and PDGF-bb (r = 0.80, p = 0.009 and r = 0.77, p = 0.01, respectively) and negatively with the proinflammatory cytokines RANTES (r = − 0.79, p = 0.01) and IL-6 (r = − 0.76, p = 0.02). Conclusion Results of the RECARDIO trial suggested safety and efficacy in terms of clinical and perfusion outcomes in patients with RA and LV dysfunction. The observed link between myocardial perfusion improvements and ATMP-CD133 secretome may represent a proof of concept for further mechanistic investigations. Trial registration ClinicalTrials.gov, NCT02059681. 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Linking cell function with perfusion: insights from the transcatheter delivery of bone marrow-derived $ CD133^{+} $ cells in ischemic refractory cardiomyopathy trial (RECARDIO)

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