Autologous Mesenchymal Stem Cells Produce Concordant Improvements in Regional Function, Tissue Perfusion, and Fibrotic Burden When Administered to Patients Undergoing Coronary Artery Bypass Grafting: The Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) Trial

RATIONALE:Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic ischemic cardiomyopathy undergoing CABG, the underlying mechanism and impact of cell injection site remain controversial. Mesenchymal ste...

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Published inCirculation research Vol. 114; no. 8; pp. 1302 - 1310
Main Authors Karantalis, Vasileios, DiFede, Darcy L., Gerstenblith, Gary, Pham, Si, Symes, James, Zambrano, Juan Pablo, Fishman, Joel, Pattany, Pradip, McNiece, Ian, Conte, John, Schulman, Steven, Wu, Katherine, Shah, Ashish, Breton, Elayne, Davis-Sproul, Janice, Schwarz, Richard, Feigenbaum, Gary, Mushtaq, Muzammil, Suncion, Viky Y., Lardo, Albert C., Borrello, Ivan, Mendizabal, Adam, Karas, Tomer Z., Byrnes, John, Lowery, Maureen, Heldman, Alan W., Hare, Joshua M.
Format Journal Article
LanguageEnglish
Published United States American Heart Association, Inc 11.04.2014
Subjects
Cardiomyopathies - therapy
Cell- and Tissue-Based Therapy - methods
Cicatrix - pathology
Cicatrix - therapy
Coronary Artery Bypass
Fibrosis - pathology
Fibrosis - therapy
Follow-Up Studies
Humans
Injections
Magnetic Resonance Imaging
Male
Mesenchymal Stem Cell Transplantation - methods
Middle Aged
Myocardial Ischemia - therapy
Myocardium - pathology
Phenotype
Prospective Studies
Time Factors
Treatment Outcome
Ventricular Dysfunction, Left - therapy
stem cell
coronary artery bypass
mesenchymal stromal cells
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Abstract RATIONALE:Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic ischemic cardiomyopathy undergoing CABG, the underlying mechanism and impact of cell injection site remain controversial. Mesenchymal stem cells (MSCs) improve LV structure and function through several effects including reducing fibrosis, neoangiogenesis, and neomyogenesis. OBJECTIVE:To test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects. METHODS AND RESULTS:Six patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons. MRI was used to measure scar, perfusion, wall thickness, and contractility at baseline, at 3, 6, and 18 months and to compare structural and functional recovery in regions that received MSC injections alone, revascularization alone, or neither. A composite score of MRI variables was used to assess concordance of antifibrotic effects, perfusion, and contraction at different regions. After 18 months, subjects receiving MSCs exhibited increased LV ejection fraction (+9.4±1.7%, P=0.0002) and decreased scar mass (−47.5±8.1%; P<0.0001) compared with baseline. MSC-injected segments had concordant reduction in scar size, perfusion, and contractile improvement (concordant score2.93±0.07), whereas revascularized (0.5±0.21) and nontreated segments (−0.07±0.34) demonstrated nonconcordant changes (P<0.0001 versus injected segments). CONCLUSIONS:Intramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution, which in turn drives improvement in global LV function. These findings, although inconclusive because of lack of placebo group, have important therapeutic and mechanistic hypothesis-generating implications. CLINICAL TRIAL REGISTRATION:URLhttp://clinicaltrials.gov/show/NCT00587990. Unique identifierNCT00587990.
AbstractList Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic ischemic cardiomyopathy undergoing CABG, the underlying mechanism and impact of cell injection site remain controversial. Mesenchymal stem cells (MSCs) improve LV structure and function through several effects including reducing fibrosis, neoangiogenesis, and neomyogenesis. To test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects. Six patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons. MRI was used to measure scar, perfusion, wall thickness, and contractility at baseline, at 3, 6, and 18 months and to compare structural and functional recovery in regions that received MSC injections alone, revascularization alone, or neither. A composite score of MRI variables was used to assess concordance of antifibrotic effects, perfusion, and contraction at different regions. After 18 months, subjects receiving MSCs exhibited increased LV ejection fraction (+9.4 ± 1.7%, P=0.0002) and decreased scar mass (-47.5 ± 8.1%; P<0.0001) compared with baseline. MSC-injected segments had concordant reduction in scar size, perfusion, and contractile improvement (concordant score: 2.93 ± 0.07), whereas revascularized (0.5 ± 0.21) and nontreated segments (-0.07 ± 0.34) demonstrated nonconcordant changes (P<0.0001 versus injected segments). Intramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution, which in turn drives improvement in global LV function. These findings, although inconclusive because of lack of placebo group, have important therapeutic and mechanistic hypothesis-generating implications. http://clinicaltrials.gov/show/NCT00587990. Unique identifier: NCT00587990.
Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic ischemic cardiomyopathy undergoing CABG, the underlying mechanism and impact of cell injection site remain controversial. Mesenchymal stem cells (MSCs) improve LV structure and function through several effects including reducing fibrosis, neoangiogenesis, and neomyogenesis.RATIONALEAlthough accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic ischemic cardiomyopathy undergoing CABG, the underlying mechanism and impact of cell injection site remain controversial. Mesenchymal stem cells (MSCs) improve LV structure and function through several effects including reducing fibrosis, neoangiogenesis, and neomyogenesis.To test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects.OBJECTIVETo test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects.Six patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons. MRI was used to measure scar, perfusion, wall thickness, and contractility at baseline, at 3, 6, and 18 months and to compare structural and functional recovery in regions that received MSC injections alone, revascularization alone, or neither. A composite score of MRI variables was used to assess concordance of antifibrotic effects, perfusion, and contraction at different regions. After 18 months, subjects receiving MSCs exhibited increased LV ejection fraction (+9.4 ± 1.7%, P=0.0002) and decreased scar mass (-47.5 ± 8.1%; P<0.0001) compared with baseline. MSC-injected segments had concordant reduction in scar size, perfusion, and contractile improvement (concordant score: 2.93 ± 0.07), whereas revascularized (0.5 ± 0.21) and nontreated segments (-0.07 ± 0.34) demonstrated nonconcordant changes (P<0.0001 versus injected segments).METHODS AND RESULTSSix patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons. MRI was used to measure scar, perfusion, wall thickness, and contractility at baseline, at 3, 6, and 18 months and to compare structural and functional recovery in regions that received MSC injections alone, revascularization alone, or neither. A composite score of MRI variables was used to assess concordance of antifibrotic effects, perfusion, and contraction at different regions. After 18 months, subjects receiving MSCs exhibited increased LV ejection fraction (+9.4 ± 1.7%, P=0.0002) and decreased scar mass (-47.5 ± 8.1%; P<0.0001) compared with baseline. MSC-injected segments had concordant reduction in scar size, perfusion, and contractile improvement (concordant score: 2.93 ± 0.07), whereas revascularized (0.5 ± 0.21) and nontreated segments (-0.07 ± 0.34) demonstrated nonconcordant changes (P<0.0001 versus injected segments).Intramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution, which in turn drives improvement in global LV function. These findings, although inconclusive because of lack of placebo group, have important therapeutic and mechanistic hypothesis-generating implications.CONCLUSIONSIntramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution, which in turn drives improvement in global LV function. These findings, although inconclusive because of lack of placebo group, have important therapeutic and mechanistic hypothesis-generating implications.http://clinicaltrials.gov/show/NCT00587990. Unique identifier: NCT00587990.CLINICAL TRIAL REGISTRATION URLhttp://clinicaltrials.gov/show/NCT00587990. Unique identifier: NCT00587990.
RATIONALE:Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic ischemic cardiomyopathy undergoing CABG, the underlying mechanism and impact of cell injection site remain controversial. Mesenchymal stem cells (MSCs) improve LV structure and function through several effects including reducing fibrosis, neoangiogenesis, and neomyogenesis. OBJECTIVE:To test the hypothesis that the impact on cardiac structure and function after intramyocardial injections of autologous MSCs results from a concordance of prorecovery phenotypic effects. METHODS AND RESULTS:Six patients were injected with autologous MSCs into akinetic/hypokinetic myocardial territories not receiving bypass graft for clinical reasons. MRI was used to measure scar, perfusion, wall thickness, and contractility at baseline, at 3, 6, and 18 months and to compare structural and functional recovery in regions that received MSC injections alone, revascularization alone, or neither. A composite score of MRI variables was used to assess concordance of antifibrotic effects, perfusion, and contraction at different regions. After 18 months, subjects receiving MSCs exhibited increased LV ejection fraction (+9.4±1.7%, P=0.0002) and decreased scar mass (−47.5±8.1%; P<0.0001) compared with baseline. MSC-injected segments had concordant reduction in scar size, perfusion, and contractile improvement (concordant score2.93±0.07), whereas revascularized (0.5±0.21) and nontreated segments (−0.07±0.34) demonstrated nonconcordant changes (P<0.0001 versus injected segments). CONCLUSIONS:Intramyocardial injection of autologous MSCs into akinetic yet nonrevascularized segments produces comprehensive regional functional restitution, which in turn drives improvement in global LV function. These findings, although inconclusive because of lack of placebo group, have important therapeutic and mechanistic hypothesis-generating implications. CLINICAL TRIAL REGISTRATION:URLhttp://clinicaltrials.gov/show/NCT00587990. Unique identifierNCT00587990.
Author Byrnes, John
Conte, John
Feigenbaum, Gary
Fishman, Joel
Heldman, Alan W.
Suncion, Viky Y.
Karas, Tomer Z.
Hare, Joshua M.
DiFede, Darcy L.
Borrello, Ivan
Wu, Katherine
Karantalis, Vasileios
Schwarz, Richard
Lowery, Maureen
Pattany, Pradip
Lardo, Albert C.
Gerstenblith, Gary
Schulman, Steven
Mushtaq, Muzammil
Davis-Sproul, Janice
McNiece, Ian
Pham, Si
Symes, James
Zambrano, Juan Pablo
Shah, Ashish
Mendizabal, Adam
Breton, Elayne
AuthorAffiliation From the University of Miami Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL (V.K., D.L.D., R.S., M.M., V.Y.S., A.W.L., J.M.H.); Johns Hopkins University, Cardiovascular Division, Baltimore, MD (G.G., S.S., E.B., J.D.-S., A.C.L.); University of Maryland, Cardiothoracic Surgery, Baltimore, MD (S.P., J.C.); Veterans Affairs Healthcare System, Cardiothoracic Surgery, Miami, FL (J.S., T.Z.K.); Jackson Health System, Cardiology, Miami, FL (J.P.Z.); University of Miami Miller School of Medicine, Radiology, Miami, FL (J.F., P.P.); University of Texas MD Anderson, Stem Cell Transplantation, Houston, TX (I.M.N.), Johns Hopkins University, Heart and Vascular Institute, Baltimore, MD (K.W.), Johns Hopkins University, Comprehensive Transplant Center (A.S.); University of Southern California, Internal Medicine, Los Angeles, CA (G.F.); Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (I.B.); EMMES Corporation, Rockville, MD (A.M.), Univer
AuthorAffiliation_xml – name: From the University of Miami Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL (V.K., D.L.D., R.S., M.M., V.Y.S., A.W.L., J.M.H.); Johns Hopkins University, Cardiovascular Division, Baltimore, MD (G.G., S.S., E.B., J.D.-S., A.C.L.); University of Maryland, Cardiothoracic Surgery, Baltimore, MD (S.P., J.C.); Veterans Affairs Healthcare System, Cardiothoracic Surgery, Miami, FL (J.S., T.Z.K.); Jackson Health System, Cardiology, Miami, FL (J.P.Z.); University of Miami Miller School of Medicine, Radiology, Miami, FL (J.F., P.P.); University of Texas MD Anderson, Stem Cell Transplantation, Houston, TX (I.M.N.), Johns Hopkins University, Heart and Vascular Institute, Baltimore, MD (K.W.), Johns Hopkins University, Comprehensive Transplant Center (A.S.); University of Southern California, Internal Medicine, Los Angeles, CA (G.F.); Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (I.B.); EMMES Corporation, Rockville, MD (A.M.), University of Miami Miller School of Medicine, Hematology/Oncology, Miami, FL (J.B.); and University of Miami Miller School of Medicine, Cardiology, Miami, FL (T.Z.K., M.L.)
Author_xml – sequence: 1
  givenname: Vasileios
  surname: Karantalis
  fullname: Karantalis, Vasileios
  organization: From the University of Miami Miller School of Medicine, Interdisciplinary Stem Cell Institute, Miami, FL (V.K., D.L.D., R.S., M.M., V.Y.S., A.W.L., J.M.H.); Johns Hopkins University, Cardiovascular Division, Baltimore, MD (G.G., S.S., E.B., J.D.-S., A.C.L.); University of Maryland, Cardiothoracic Surgery, Baltimore, MD (S.P., J.C.); Veterans Affairs Healthcare System, Cardiothoracic Surgery, Miami, FL (J.S., T.Z.K.); Jackson Health System, Cardiology, Miami, FL (J.P.Z.); University of Miami Miller School of Medicine, Radiology, Miami, FL (J.F., P.P.); University of Texas MD Anderson, Stem Cell Transplantation, Houston, TX (I.M.N.), Johns Hopkins University, Heart and Vascular Institute, Baltimore, MD (K.W.), Johns Hopkins University, Comprehensive Transplant Center (A.S.); University of Southern California, Internal Medicine, Los Angeles, CA (G.F.); Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (I.B.); EMMES Corporation, Rockville, MD (A.M.), University of Miami Miller School of Medicine, Hematology/Oncology, Miami, FL (J.B.); and University of Miami Miller School of Medicine, Cardiology, Miami, FL (T.Z.K., M.L.)
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  fullname: Zambrano, Juan Pablo
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  fullname: Fishman, Joel
– sequence: 8
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  surname: Feigenbaum
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  surname: Suncion
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  fullname: Suncion, Viky Y.
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  givenname: Albert
  surname: Lardo
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  fullname: Lardo, Albert C.
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  givenname: Ivan
  surname: Borrello
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  surname: Hare
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  fullname: Hare, Joshua M.
BackLink https://www.ncbi.nlm.nih.gov/pubmed/24565698$$D View this record in MEDLINE/PubMed
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Snippet RATIONALE:Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with...
Although accumulating data support the efficacy of intramyocardial cell-based therapy to improve left ventricular (LV) function in patients with chronic...
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SubjectTerms Cardiomyopathies - therapy
Cell- and Tissue-Based Therapy - methods
Cicatrix - pathology
Cicatrix - therapy
Coronary Artery Bypass
Fibrosis - pathology
Fibrosis - therapy
Follow-Up Studies
Humans
Injections
Magnetic Resonance Imaging
Male
Mesenchymal Stem Cell Transplantation - methods
Middle Aged
Myocardial Ischemia - therapy
Myocardium - pathology
Phenotype
Prospective Studies
Time Factors
Treatment Outcome
Ventricular Dysfunction, Left - therapy
Title Autologous Mesenchymal Stem Cells Produce Concordant Improvements in Regional Function, Tissue Perfusion, and Fibrotic Burden When Administered to Patients Undergoing Coronary Artery Bypass Grafting: The Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) Trial
URI https://www.ncbi.nlm.nih.gov/pubmed/24565698
https://www.proquest.com/docview/1515648604
Volume 114
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