Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial
Background Most cell therapy trials failed to show an improvement in global left ventricular (LV) function measures after myocardial infarction (MI). Myocardial segments are heterogeneously impacted by MI. Global LV function indices are not able to detect the small treatment effects on segmental myo...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2021-12-01
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| Series: | Open Heart |
| Online Access: | https://openheart.bmj.com/content/8/2/e001614.full |
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| author | Timothy D Henry Dean J Kereiakes Joao A C Lima Bharath Ambale-Venkatesh Mohammad R Ostovaneh Deborah Ascheim Raj R Makkar Tarun Chakravarty Glen Kowalchuk Frank V Aguirre Thomas J Povsic Richard Schatz Jay H Traverse Janice Pogoda Rachel D Smith Linda Marbán Eduardo Marbán |
| author_facet | Timothy D Henry Dean J Kereiakes Joao A C Lima Bharath Ambale-Venkatesh Mohammad R Ostovaneh Deborah Ascheim Raj R Makkar Tarun Chakravarty Glen Kowalchuk Frank V Aguirre Thomas J Povsic Richard Schatz Jay H Traverse Janice Pogoda Rachel D Smith Linda Marbán Eduardo Marbán |
| author_sort | Timothy D Henry |
| collection | DOAJ |
| description | Background Most cell therapy trials failed to show an improvement in global left ventricular (LV) function measures after myocardial infarction (MI). Myocardial segments are heterogeneously impacted by MI. Global LV function indices are not able to detect the small treatment effects on segmental myocardial function which may have prognostic implications for cardiac events. We aimed to test the efficacy of allogeneic cardiosphere-derived cells (CDCs) for improving regional myocardial function and contractility.Methods In this exploratory analysis of a randomised clinical trial, 142 patients with post-MI with LVEF <45% and 15% or greater LV scar size were randomised in 2:1 ratio to receive intracoronary infusion of allogenic CDCs or placebo, respectively. Change in segmental myocardial circumferential strain (Ecc) by MRI from baseline to 6 months was compared between CDCs and placebo groups.Results In total, 124 patients completed the 6-month follow-up (mean (SD) age 54.3 (10.8) and 108 (87.1%) men). Segmental Ecc improvement was significantly greater in patients receiving CDC (−0.5% (4.0)) compared with placebo (0.2% (3.7), p=0.05). The greatest benefit for improvement in segmental Ecc was observed in segments containing scar tissue (change in segmental Ecc of −0.7% (3.5) in patients receiving CDC vs 0.04% (3.7) in the placebo group, p=0.04).Conclusions In patients with post-MI LV dysfunction, CDC administration resulted in improved segmental myocardial function. Our findings highlight the importance of segmental myocardial function indices as an endpoint in future clinical trials of patients with post-MI.Trial registration number NCT01458405. |
| format | Article |
| id | doaj-art-5f984ac4b00a4397bee0814dd78687bb |
| institution | Kabale University |
| issn | 2053-3624 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Open Heart |
| spelling | doaj-art-5f984ac4b00a4397bee0814dd78687bb2024-11-12T03:30:08ZengBMJ Publishing GroupOpen Heart2053-36242021-12-018210.1136/openhrt-2021-001614Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trialTimothy D Henry0Dean J Kereiakes1Joao A C Lima2Bharath Ambale-Venkatesh3Mohammad R Ostovaneh4Deborah Ascheim5Raj R Makkar6Tarun Chakravarty7Glen Kowalchuk8Frank V Aguirre9Thomas J Povsic10Richard Schatz11Jay H Traverse12Janice Pogoda13Rachel D Smith14Linda Marbán15Eduardo Marbán163 The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio, USAThe Christ Hospital Health Network, Cincinnati, Ohio, USADivision of Cardiology, Johns Hopkins University, Baltimore, Maryland, USADivision of Cardiology, Johns Hopkins University, Baltimore, Maryland, USADivision of Cardiology, Johns Hopkins University, Baltimore, Maryland, USACapricor Therapeutics Inc, Los Angles, California, USASmidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USASmidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USASanger Heart and Vascular Institute, Charlotte, North Carolina, USAPrairie Heart Institute, Springfield, Illinois, USADuke Clinical Research Institute and Duke Medicine, Durham, North Carolina, USAScripps Clinic, La Jolla, California, USAMinneapolis Heart Institute Foundation, Minneapolis, Minnesota, USACipher Biostatistics and Reporting, Reno, Nevada, USACapricor Therapeutics Inc, Los Angles, California, USACapricor Therapeutics Inc, Los Angles, California, USASmidt Heart Institute, Cedars-Sinai Medical Center, Los Angles, California, USABackground Most cell therapy trials failed to show an improvement in global left ventricular (LV) function measures after myocardial infarction (MI). Myocardial segments are heterogeneously impacted by MI. Global LV function indices are not able to detect the small treatment effects on segmental myocardial function which may have prognostic implications for cardiac events. We aimed to test the efficacy of allogeneic cardiosphere-derived cells (CDCs) for improving regional myocardial function and contractility.Methods In this exploratory analysis of a randomised clinical trial, 142 patients with post-MI with LVEF <45% and 15% or greater LV scar size were randomised in 2:1 ratio to receive intracoronary infusion of allogenic CDCs or placebo, respectively. Change in segmental myocardial circumferential strain (Ecc) by MRI from baseline to 6 months was compared between CDCs and placebo groups.Results In total, 124 patients completed the 6-month follow-up (mean (SD) age 54.3 (10.8) and 108 (87.1%) men). Segmental Ecc improvement was significantly greater in patients receiving CDC (−0.5% (4.0)) compared with placebo (0.2% (3.7), p=0.05). The greatest benefit for improvement in segmental Ecc was observed in segments containing scar tissue (change in segmental Ecc of −0.7% (3.5) in patients receiving CDC vs 0.04% (3.7) in the placebo group, p=0.04).Conclusions In patients with post-MI LV dysfunction, CDC administration resulted in improved segmental myocardial function. Our findings highlight the importance of segmental myocardial function indices as an endpoint in future clinical trials of patients with post-MI.Trial registration number NCT01458405.https://openheart.bmj.com/content/8/2/e001614.full |
| spellingShingle | Timothy D Henry Dean J Kereiakes Joao A C Lima Bharath Ambale-Venkatesh Mohammad R Ostovaneh Deborah Ascheim Raj R Makkar Tarun Chakravarty Glen Kowalchuk Frank V Aguirre Thomas J Povsic Richard Schatz Jay H Traverse Janice Pogoda Rachel D Smith Linda Marbán Eduardo Marbán Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial Open Heart |
| title | Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial |
| title_full | Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial |
| title_fullStr | Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial |
| title_full_unstemmed | Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial |
| title_short | Effect of cardiosphere-derived cells on segmental myocardial function after myocardial infarction: ALLSTAR randomised clinical trial |
| title_sort | effect of cardiosphere derived cells on segmental myocardial function after myocardial infarction allstar randomised clinical trial |
| url | https://openheart.bmj.com/content/8/2/e001614.full |
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