Stem cell therapy for chronic ischaemic heart disease and congestive heart failure
- PMID: 28012165
- PMCID: PMC6463978
- DOI: 10.1002/14651858.CD007888.pub3
Stem cell therapy for chronic ischaemic heart disease and congestive heart failure
Abstract
Background: A promising approach to the treatment of chronic ischaemic heart disease and congestive heart failure is the use of stem cells. The last decade has seen a plethora of randomised controlled trials developed worldwide, which have generated conflicting results.
Objectives: The critical evaluation of clinical evidence on the safety and efficacy of autologous adult bone marrow-derived stem/progenitor cells as a treatment for chronic ischaemic heart disease and congestive heart failure.
Search methods: We searched CENTRAL in the Cochrane Library, MEDLINE, Embase, CINAHL, LILACS, and four ongoing trial databases for relevant trials up to 14 December 2015.
Selection criteria: Eligible studies were randomised controlled trials comparing autologous adult stem/progenitor cells with no cells in people with chronic ischaemic heart disease and congestive heart failure. We included co-interventions, such as primary angioplasty, surgery, or administration of stem cell mobilising agents, when administered to treatment and control arms equally.
Data collection and analysis: Two review authors independently screened all references for eligibility, assessed trial quality, and extracted data. We undertook a quantitative evaluation of data using random-effects meta-analyses. We evaluated heterogeneity using the I2 statistic and explored substantial heterogeneity (I2 greater than 50%) through subgroup analyses. We assessed the quality of the evidence using the GRADE approach. We created a 'Summary of findings' table using GRADEprofiler (GRADEpro), excluding studies with a high or unclear risk of selection bias. We focused our summary of findings on long-term follow-up of mortality, morbidity outcomes, and left ventricular ejection fraction measured by magnetic resonance imaging.
Main results: We included 38 randomised controlled trials involving 1907 participants (1114 cell therapy, 793 controls) in this review update. Twenty-three trials were at high or unclear risk of selection bias. Other sources of potential bias included lack of blinding of participants (12 trials) and full or partial commercial sponsorship (13 trials).Cell therapy reduced the incidence of long-term mortality (≥ 12 months) (risk ratio (RR) 0.42, 95% confidence interval (CI) 0.21 to 0.87; participants = 491; studies = 9; I2 = 0%; low-quality evidence). Periprocedural adverse events associated with the mapping or cell/placebo injection procedure were infrequent. Cell therapy was also associated with a long-term reduction in the incidence of non-fatal myocardial infarction (RR 0.38, 95% CI 0.15 to 0.97; participants = 345; studies = 5; I2 = 0%; low-quality evidence) and incidence of arrhythmias (RR 0.42, 95% CI 0.18 to 0.99; participants = 82; studies = 1; low-quality evidence). However, we found no evidence that cell therapy affects the risk of rehospitalisation for heart failure (RR 0.63, 95% CI 0.36 to 1.09; participants = 375; studies = 6; I2 = 0%; low-quality evidence) or composite incidence of mortality, non-fatal myocardial infarction, and/or rehospitalisation for heart failure (RR 0.64, 95% CI 0.38 to 1.08; participants = 141; studies = 3; I2 = 0%; low-quality evidence), or long-term left ventricular ejection fraction when measured by magnetic resonance imaging (mean difference -1.60, 95% CI -8.70 to 5.50; participants = 25; studies = 1; low-quality evidence).
Authors' conclusions: This systematic review and meta-analysis found low-quality evidence that treatment with bone marrow-derived stem/progenitor cells reduces mortality and improves left ventricular ejection fraction over short- and long-term follow-up and may reduce the incidence of non-fatal myocardial infarction and improve New York Heart Association (NYHA) Functional Classification in people with chronic ischaemic heart disease and congestive heart failure. These findings should be interpreted with caution, as event rates were generally low, leading to a lack of precision.
Conflict of interest statement
Professor Anthony Mathur was the chief investigator of four included studies (Hamshere 2015_IC; Hamshere 2015_IM; Mozid 2014_IC; Mozid 2014_IM), and is the lead investigator of the ongoing BAMI trial.
All other authors have no known conflicts of interest.
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Update of
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Stem cell therapy for chronic ischaemic heart disease and congestive heart failure.Cochrane Database Syst Rev. 2014 Apr 29;(4):CD007888. doi: 10.1002/14651858.CD007888.pub2. Cochrane Database Syst Rev. 2014. Update in: Cochrane Database Syst Rev. 2016 Dec 24;12:CD007888. doi: 10.1002/14651858.CD007888.pub3. PMID: 24777540 Updated.
References
References to studies included in this review
Ang 2008 {published data only}
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Assmus 2006 {published data only}
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Assmus 2013 {published data only}
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Bartunek 2012 {published data only}
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Chen 2006 {published data only}
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Erbs 2005 {published data only}
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Hamshere 2015_IC {published and unpublished data}
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Heldman 2014_BMMNC {published data only}
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- NCT00768066. The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC‐HFT). clinicaltrials.gov/show/NCT00768066 First received 3 October 2008.
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Heldman 2014_BM‐MSC {published data only}
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Hendrikx 2006 {published data only}
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Honold 2012 {published data only}
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Hu 2011 {published data only}
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Jimenez‐Quevedo 2011 {published data only}
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- Jimenez‐Quevedo P, Gonzalez FJ, Llorente L, Sabate M, Garcia MX, Hernandez‐Antolin R, et al. Selected CD133+ endothelial progenitor cells to create angiogenesis in no‐option patients: The design of the PROGENITOR randomized trial. European Heart Journal 2011;32:816: Abstract P4654.
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- Jimenez‐Quevedo P, Gonzalez‐Ferrer JJ, Sabate M, Garcia‐Moll X, Delgado‐Bolton R, Llorente L, et al. Selected CD133+ progenitor cells to promote angiogenesis in patients with refractory angina: final results of the PROGENITOR randomized trial. Circulation Research 2014;115(11):950‐60. - PubMed
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Losordo 2007 {published data only}
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- Losordo DW, Henry TD, Schatz RA, Sup Lee J, Costa M, Bass T, et al. Randomized, double‐blind, placebo‐controlled trial of autologous CD34+ cell therapy for refractory angina: 2‐year safety analysis. American Heart Association Scientific Sessions, 2010 November 13‐17, Chicago, IL. Circulation 2010;122 (21 Suppl 1):Abstract A15621.
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- Losordo DW, Kearney M, Patel S, Poh K‐K, Shah P, Welt F, et al. Randomized, double‐blind, placebo controlled pilot trial of intramyocardial autologous CD34 cell therapy for intractable angina. American Heart Association Scientific Sessions 2006, 2006 November 12‐15, Chicago, IL. Circulation 2006;114 (18 Suppl):Abstract 3361.
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- Losordo DW, Schatz RA, White CJ, Udelson JE, Veereshwarayya V, Durgin M, et al. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double‐blind, randomized controlled trial. Circulation 2007;115(25):3165‐72. [PUBMED: 17562958] - PubMed
Losordo 2011 {published data only}
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- Junge CE, Motlagh D, Debelak J, Cohen A, Hammel S, Nada A, et al. Clinical parameters influencing cell mobilization and impact of mobilization ability on efficacy outcomes: An analysis from ACT34‐CMI. American Heart Association 2012 Scientific Sessions and Resuscitation Science Symposium, 2012 November 3‐6, Los Angeles, CA. Circulation 2012;126 (21 Suppl 1):Abstract 12015.
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- Livingston D, Motlagh D, Debelak J, Cohen A, Story K, Hammel S, et al. Phase 2 study of intramyocardial injection of autologous CD34+ cells to treat subjects with refractory chronic myocardial ischemia (CMI): Factors influencing mobilization and apheresis. 51st Annual Meeting of the American Society of Hematology, ASH, 2009 December 5‐8, New Orleans, LA. Blood 2009;114:Abstract 3227.
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- Losordo DW, Henry T, Schatz RA, Lee JS, Costa M, Bass T, et al. Autologous CD34+ cell therapy for refractory angina: 12 month results of the phase II ACT34‐CMI study. American Heart Association Scientific Sessions 2009, 2009 November 14‐18, Orlando, FL. Circulation 2009;120 (18 Suppl):Abstract 5638.
Mathiasen 2015 {published data only}
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- NCT00644410. Autologous mesenchymal stromal cell therapy in heart failure. clinicaltrials.gov/show/NCT00644410 First received 20 March 2008.
Mozid 2014_IC {published data only}
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- Mozid A, Arnous S, Yeo C, Brookman P, Preston M, Archbold A, et al. Head‐to‐head comparison of different delivery methods of autologous bone marrow progenitor cells in chronic ischaemic heart failure. European Society of Cardiology Congress, 2010 August 28‐ September 1, Stockholm, Sweden. European Heart Journal 2011;32 (16 Suppl 1):456.
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- Mozid A, Yeo C, Arnous S, Ako E, Saunders N, Locca D, et al. Safety and feasibility of intramyocardial versus intracoronary delivery of autologous cell therapy in advanced heart failure: the REGENERATE‐IHD pilot study. Regenerative Medicine 2014;9(3):269‐78. - PubMed
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- Mozid AM, Holstensson M, Choudhury T, Ben‐Haim S, Allie R, Martin J, et al. Clinical feasibility study to detect angiogenesis following bone marrow stem cell transplantation in chronic ischaemic heart failure. Nuclear Medicine Communications 2014;35(8):839‐48. - PubMed
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- Papalia F, Mozid AM, Davies LC, Mathur A. Incidence of left ventricular thrombus in patients with severe ischaemic left ventricular systolic dysfunction. Heart Failure 2012, 2012 May 19‐22, Belgrade, Serbia. European Journal of Heart Failure, Supplement 2012;11:161‐2.
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- Yeo C, Locca D, Wong J, Burchell T, Preston M, Brookman P, et al. Ejection fraction and NYHA class in heart failure in the REGENERATE‐IHD stem cell study: A comparison between the intramyocardial intracoronary arms. American Journal of Cardiology 2009;104 (6 Suppl 1):190D‐1D.
Mozid 2014_IM {published data only}
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- Mozid A, Arnous S, Yeo C, Brookman P, Preston M, Archbold A, et al. Head‐to‐head comparison of different delivery methods of autologous bone marrow progenitor cells in chronic ischaemic heart failure. European Society of Cardiology Congress, 2010 August 28‐September 1, Stockholm, Sweden. European Heart Journal 2011;32 (16 Suppl 1):456.
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- Mozid A, Yeo C, Arnous S, Ako E, Saunders N, Locca D, et al. Safety and feasibility of intramyocardial versus intracoronary delivery of autologous cell therapy in advanced heart failure: the REGENERATE‐IHD pilot study. Regenerative Medicine 2014;9(3):269‐78. - PubMed
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- Mozid AM, Holstensson M, Choudhury T, Ben‐Haim S, Allie R, Martin J, et al. Clinical feasibility study to detect angiogenesis following bone marrow stem cell transplantation in chronic ischaemic heart failure. Nuclear Medicine Communications 2014;35(8):839‐48. - PubMed
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- Papalia F, Mozid AM, Davies LC, Mathur A. Incidence of left ventricular thrombus in patients with severe ischaemic left ventricular systolic dysfunction. Heart Failure 2012, 2012 May 19‐22, Belgrade, Serbia. European Journal of Heart Failure, Supplement 2012;11:161‐2.
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- Yeo C, Locca D, Wong J, Burchell T, Preston M, Brookman P, et al. Ejection fraction and NYHA class in heart failure in the REGENERATE‐IHD stem cell study: A comparison between the intramyocardial intracoronary arms. American Journal of Cardiology 2009;104 (6 Suppl 1):190D‐1D.
Nasseri 2012 {published data only}
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- NCT00462774. Bypass surgery and CD133 marrow cell injection for treatment of ischemic heart failure (Cardio133). www.clinicaltrials.gov/ct2/show/NCT00462774 First received 18 April 2007.
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- Nasseri BA, Ebell W, Dandel M, Kukucka M, Gebker R, Doltra A, et al. Autologous CD133+ bone marrow cells and bypass grafting for regeneration of ischaemic myocardium: The CARDIO133 trial. European Heart Journal 2014;35(19):1263‐74. - PubMed
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- Nasseri BA, Kikucha M, Dandel M, Ebell W, Hetzer R, Stamm C. Autologous CD133+ bone marrow cells and bypass grafting for regeneration of ischemic myocardium: Results of the CARDIO133 trial. Journal of the American College of Cardiology 2012;59 (13 Suppl 1):E864.
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- Nasseri BA, Klose K, Ebell W, Dandel M, Kukucka M, Gebker R, et al. Improved regional contractile function and reduced scar size after clinical cell therapy with CD133‐positive cells. 3rd EACTS Meeting on Cardiac and Pulmonary Regeneration, 2012 December 14‐15, Berlin, Germany. Interactive Cardiovascular and Thoracic Surgery 2013;16 (2):S233.
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- Nasseri BA, Kukucka M, Dandel M, Ebell W, Gebker R, Hetzer R, et al. Results of the Cardio133 trial: A randomized double‐blinded controlled trial of intramyocardial injection of autologous CD133+ bone marrow cells during bypass grafting. 42nd Annual Meeting of the German Society for Cardiovascular and Thoracic Surgery, 2013 February 17‐20, Freiburg, Germany. Thoracic and Cardiovascular Surgeon 2013;61.
Patel 2005 {published data only}
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- Patel AN, Geffner L, Vina RF, Saslavsky J, Urschel HC Jr, Kormos R, et al. Surgical treatment for congestive heart failure with autologous adult stem cell transplantation: a prospective randomized study. Journal of Thoracic and Cardiovascular Surgery 2005;130(6):1631‐8. [PUBMED: 16308009] - PubMed
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- Patel AN, Mittal S, Vina RF, Benetti F, Trehan N. Long term follow‐up of coronary artery bypass grafting with autologous bone marrow cell therapy. 20th Annual Meeting of the International Society for Cell Therapy, ISCT 2014, 23‐26 April 2014, Paris, France. Cytotherapy 2014;16:S39.
Patel 2015 {published data only}
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- NCT01299324. Retrograde delivery of BMAC (bone marrow aspirate concentrate) for congestive heart failure. clinicaltrials.gov/show/NCT01299324 First received 10 January 2011.
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- Patel AN, Ince H, Mittal S, Turan G, Trehan N. Retrograde delivery of autologous concentrated bone marrow cell therapy for patients with congestive heart failure ‐ REVIVE‐1 a prospective randomized study. 20th Annual Meeting of the International Society for Cell Therapy, ISCT 2014, 2014 April 23‐26, Paris, France. Cytotherapy 2014;16:S39.
Patila 2014 {published data only}
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- Lehtinen M, Patila T, Kankuri E, Lauerma K, Sinisalo J, Laine M, et al. Intramyocardial bone marrow mononuclear cell transplantation in ischemic heart failure: Long‐term follow‐up. Journal of Heart and Lung Transplantation 2015;34(7):899‐905. - PubMed
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- Lehtinen M, Patila T, Vento A, Kankuri E, Suojaranta‐Ylinen R, Poyhia R. Prospective, randomized, double‐blinded trial of bone marrow cell transplantation combined with coronary surgery ‐ perioperative safety study. Interactive Cardiovascular and Thoracic Surgery 2014;19(6):990‐6. - PubMed
-
- NCT00418418. Combined CABG and stem‐cell transplantation for heart failure. clinicaltrials.gov/show/NCT00418418 First received 3 January 2007.
-
- Patila T, Lehtinen M, Vento A, Schildt J, Sinisalo J, Laine M. Bone marrow mononuclear cells for ischemic cardiac failure ‐ A prospective, controlled, randomized, double‐blinded study of cell transplantation combined with coronary bypass surgery. 20th Annual Meeting of the International Society for Cell Therapy, ISCT 2014, 2014 April 23‐26, Paris, France. Cytotherapy 2014;16:S9‐S10.
-
- Patila T, Lehtinen M, Vento A, Schildt J, Sinisalo J, Laine M, et al. Autologous bone marrow mononuclear cell transplantation in ischemic heart failure: A prospective, controlled, randomized, double‐blind study of cell transplantation combined with coronary bypass. Journal of Heart and Lung Transplantation 2014;33(6):567‐74. - PubMed
Perin 2011 {published data only}
-
- NCT00203203. Autologous stem cells for cardiac angiogenesis (FOCUS HF). clinicaltrials.gov/show/NCT00203203 First received 12 September 2005.
-
- Perin EC, Silva GV, Fernandes MR, Henry T, Moore W, Coulter S, et al. FOCUS‐HF: The first US randomized blinded controlled trial of transendocardial injection of bone marrow mononuclear cells in chronic severe ischemic heart failure patients. American College of Cardiology 58th Annual Scientific Session and i2 Summit: Innovation in Intervention, 2009 September 29‐31, Orlando, FL. Journal of the American College of Cardiology 2009;53 (10 Suppl):A193, Abstract 1051‐191.
-
- Perin EC, Silva GV, Henry TD, Cabreira‐Hansen MG, Moore WH, Coulter SA, et al. A randomized study of transendocardial injection of autologous bone marrow mononuclear cells and cell function analysis in ischemic heart failure (FOCUS‐HF). American Heart Journal 2011;161(6):1078‐87.e3. [PUBMED: 21641354] - PubMed
Perin 2012a {published data only}
-
- NCT00824005. Effectiveness of stem cell treatment for adults with ischemic cardiomyopathy (The FOCUS Study). clinicaltrials.gov/ct2/show/NCT00824005 First received 15 January 2009.
-
- Perin EC, Willerson TJ, Pepine CJ, Henry TD, Ellis SG, Zhao DX, et al. Cardiovascular Cell Therapy Research Network CCTRN. Effect of transendocardial delivery of autologous bone marrow mononuclear cells on functional capacity, left ventricular function, and perfusion in chronic heart failure: the FOCUS‐CCTRN trial. JAMA 2012;307(16):1717‐26. - PMC - PubMed
-
- Willerson JT, Perin EC, Ellis SG, Pepine CJ, Henry TD, Zhao DX, et al. Intramyocardial injection of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction (First Mononuclear Cells injected in the US [FOCUS]): Rationale and design. American Heart Journal 2010;160(2):215‐23. [PUBMED: 20691824] - PMC - PubMed
Perin 2012b {published data only}
-
- NCT00314366. Injection of autologous aldehyde dehydrogenase‐bright stem cells for therapeutic angiogenesis (FOCUS Br). clinicaltrials.gov/show/NCT00314366 First received 10 April 2006.
-
- Perin EC, Silva GV, Zheng Y, Fernandez MR, Moore W, Coulter S, et al. First in man transendocardial injection of autologous aldehyde dehydrogenase‐bright cells in heart failure patients (FOCUS‐Bright). American Heart Association Scientific Sessions 2009; 2009 November 14‐18, Orlando, FL. Circulation 2009;120 (18 Suppl):Abstract 3502.
-
- Perin EC, Silva GV, Zheng Y, Gahremanpour A, Canales J, Patel D, et al. Randomized, double‐blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase‐bright stem cells in patients with ischemic heart failure. American Heart Journal 2012;163(3):415‐21, 421.e1. [PUBMED: 22424012] - PubMed
Pokushalov 2010 {published data only}
-
- Pokushalov E, Romanov A, Artemenko S, Cherniavskiy A, Larionov P, Terehov I, et al. Efficacy of intramyocardial injections of autologous bone marrow mononuclear stem cells in patients with ischemic heart failure: Long term results: ACC poster contributions. Amercan College of Cardiology's 59th Annual Scientific Session and i2 Summit: Innovation in Intervention, 2010 March 14‐16, Atlanta, GA. Journal of the American College of Cardiology 2010;55 (10 Suppl 1):A24: Abstract E228.
-
- Pokushalov E, Romanov A, Artemenko S, Larionov P, Cherniavskiy A. Efficiency of intramyocardial injections of autologous bone marrow mononuclear stem cells in patients with ischemic heart failure: Long‐term results. 13th Annual Scientific Meeting of the Heart Failure Society of America, 2009 September 13‐16, Boston, MA. Journal of Cardiac Failure 2009;15 (6 Suppl 1):S44, Abstract 138.
-
- Pokushalov E, Romanov A, Cherniavskiy A, Artemenko S, Larionov P, Terehov I, et al. Efficiency of intramyocardial injections of autologous bone marrow mononuclear stem cells in patients with ischemic heart failure: Long‐term results. Transcatheter Cardiovascular Therapeutics Symposium, 2009 September 21‐15, San Francisco, CA. American Journal of Cardiology 2009;104 (6 Suppl 1):74D‐5D, Abstract TCT‐194.
-
- Pokushalov E, Romanov A, Chernyavsky A, Larionov P, Terekhov I, Artyomenko S, et al. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. Journal of Cardiovascular Translational Research 2010;3(2):160‐8. [PUBMED: 20560030] - PubMed
-
- Romanov A, Pokushalov E, Artemenko S, Larionov P, Terehov I, Kliver E, et al. Efficiency of intramyocardial injections of autologous bone marrow mononuclear stem cells in patients with ischemic heart failure: long‐term results. European Society of Cardiology Congress 2009, 2009 August 29‐September 2, Barcelona, Spain. European Heart Journal 2009;30 (Suppl 1):504, Abstract P3097.
Santoso 2014 {published data only}
-
- ACTRN12611000219987. A study of the effect of direct endomyocardial injection of autologous bone marrow cells on left ventricular ejection function in patients with "end‐stage" ischaemic heart failure. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=335320 First received 30 March 2010.
-
- HKUCTR‐763. Direct endomyocardial injection of autologous bone marrow cells for treatment of patients with "end‐stage" ischemic heart failure. www.hkuctr.com First received 16 October 2008.
-
- NCT01150175. Direct endomyocardial injection of autologous bone marrow cells to treat ischaemic heart failure (END‐HF). clinicaltrials.gov/show/NCT01150175 First received 24 May 2010.
-
- Santoso T, Siu CW, Irawan C, Chan WS, Alwi I, Yiu KH, et al. A randomized placebo controlled trial of endomyocardial implantation of autologous bone marrow mononuclear cells in advanced ischemic heart failure (END‐HF). European Society of Cardiology, ESC Congress 2013, 2013 August 31‐September 4, Amsterdam, Netherlands. European Heart Journal 2013;34:652.
-
- Santoso T, Siu CW, Irawan C, Chan WS, Alwi I, Yiu KH, et al. Endomyocardial implantation of autologous bone marrow mononuclear cells in advanced ischemic heart failure: a randomized placebo‐controlled trial (END‐HF). Journal of Cardiovascular Translational Research 2014;7(6):545‐52. - PubMed
Trifunovic 2015 {published data only}
-
- Trifunovic Z, Obradovic S, Balint B, Ilic R, Vukic Z, Sisic M, et al. Functional recovery of patients with ischemic cardiomyopathy treated with coronary artery bypass surgery and concomitant intramyocardial bone marrow mononuclear cell implantation ‐ a long‐term follow‐up study. Vojnosanit Pregl 2015;72(3):225‐32. - PubMed
Tse 2007 {published data only}
-
- Chan CW, Kwong YL, Kwong RY, Lau CP, Tse HF. Improvement of myocardial perfusion reserve detected by cardiovascular magnetic resonance after direct endomyocardial implantation of autologous bone marrow cells in patients with severe coronary artery disease. Journal of Cardiovascular Magnetic Resonance 2010;12:6. [PUBMED: 20100336] - PMC - PubMed
-
- Tse HF, Thambar S, Kwong YL, Rowlings P, Bellamy G, McCrohon J, et al. Prospective randomized trial of direct endomyocardial implantation of bone marrow cells for treatment of severe coronary artery diseases (PROTECT‐CAD trial). European Heart Journal 2007;28(24):2998‐3005. [PUBMED: 17984132] - PubMed
Turan 2011 {published data only}
-
- Turan RG, Bozdag‐Turan I, Ortak J, Akin I, Kische S, Schneider H, et al. Improved mobilization of the CD34(+) and CD133(+) bone marrow‐derived circulating progenitor cells by freshly isolated intracoronary bone marrow cell transplantation in patients with ischemic heart disease. Stem Cells and Development 2011;20(9):1491‐501. [PUBMED: 21190450] - PMC - PubMed
-
- Turan RG, Bozdag‐Turan I, Ortak J, Kische S, Akin I, Schneider H, et al. Improved functional activity of bone marrow derived circulating progenitor cells after intra coronary freshly isolated bone marrow cells transplantation in patients with ischemic heart disease. Stem Cell Reviews 2011;7(3):646‐56. [PUBMED: 21188654] - PMC - PubMed
Van Ramshorst 2009 {published data only}
-
- ISRCTN58194927. Randomised, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no‐option patients with refractory angina pectoris and documented ischaemia. www.isrctn.com/ISRCTN58194927 First received 27 January 2006.
-
- NTR400. Randomized, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no‐option patients with refractory angina pectoris and documented ischemia. www.trialregister.nl/trialreg/admin/rctview.asp?TC=400 First received 27 January 2006.
-
- Rodrigo S, Ramshorst J, Beeres SL, Al Younis I, Dibbets‐Schneider P, Roos A, et al. Intramyocardial injection of bone marrow mononuclear cells in chronic myocardial ischemia patients after previous placebo injection improves myocardial perfusion and anginal symptoms: An intra‐patient comparison. American Heart Journal 2012;164(5):771‐8. - PubMed
-
- Rodrigo S, Ramshorst J, Beeres SL, Dibbets‐Schneider P, Roos A, Fibbe WE, et al. Intramyocardial injection of bone marrow mononuclear cells in patients with chronic myocardial ischemia: An intra‐patient comparison. Circulation 2011;124(Suppl 1):A15175.
-
- Rodrigo S, Ramshorst J, Beeres SL, Dibbets‐Schneider P, Stokkel M, Fibbe WE, et al. Intramyocardial bone marrow cell injection in patients with chronic myocardial ischemia: Results long term follow‐up. American Heart Association Scientific Sessions, 2011 November 12‐16, Orlando, FL. Circulation 2011;124 (21 Suppl 1):Abstract A15175.
Wang 2009 {published data only}
-
- Wang S‐H, Cui J‐Y, Lu M, Wang X, Li, X‐M, Tan C, et al. Intracoronary transplantation with autologous bone marrow CD34+ stem cells for angina: a randomized controlled clinical analysis. Journal of Clinical Rehabilitative Tissue Engineering Research 2009;13(14):2623‐6.
Wang 2010 {published data only}
Wang 2014 {published data only}
-
- Wang X, Bai M, Huang S, Jie Q. Autologous CD133+ bone marrow cells for regeneration of ischaemic myocardium. 25th Great Wall International Congress of Cardiology, Asia Pacific Heart Congress 2014, and the International Congress Cardiovascular Prevention and Rehabilitation 2014, 2014 October 16‐19, Beijing, China. Journal of the American College of Cardiology 2014;64 (16 Suppl 1):C116.
Wang 2015 {published data only}
-
- Wang H, Wang Z, Jiang H, Ma D, Zhou W, Zhang G, et al. Effect of autologous bone marrow cell transplantation combined with off‐pump coronary artery bypass grafting on cardiac function in patients with chronic myocardial infarction. Cardiology 2015;130(1):27‐33. - PubMed
Yao 2008 {published data only}
-
- Yao K, Huang R, Qian J, Cui J, Ge L, Li Y, et al. Administration of intracoronary bone marrow mononuclear cells on chronic myocardial infarction improves diastolic function. Heart (British Cardiac Society) 2008;94(9):1147‐53. [PUBMED: 18381377] - PubMed
Zhao 2008 {published data only}
-
- Zhao Q, Sun Y, Xia L, Chen A, Wang Z. Randomized study of mononuclear bone marrow cell transplantation in patients with coronary surgery. Annals of Thoracic Surgery 2008;86(6):1833‐40. [PUBMED: 19021989] - PubMed
References to studies excluded from this review
Ascheim 2014 {published data only}
-
- NCT01442129. The effect of intramyocardial injection of mesenchymal precursor cells on myocardial function in patients undergoing LVAD implantation. clinicaltrials.gov/ct2/show/NCT01442129 First received 26 September 2011.
Assmann 2014 {published data only}
Beeres 2006 {published data only}
-
- Beeres SL, Bax JJ, Dibbets‐Schneider P, Stokkel MP, Fibbe WE, Wall EE, et al. Sustained effect of autologous bone marrow mononuclear cell injection in patients with refractory angina pectoris and chronic myocardial ischemia: twelve‐month follow‐up results. American Heart Journal 2006;152(4):684.e11‐6. [PUBMED: 16996834] - PubMed
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- Rodrigo SF, Ramshorst J, Mann I, Leong DP, Cannegieter SC, Al Younis I, et al. Predictors of response to intramyocardial bone marrow cell treatment in patients with refractory angina and chronic myocardial ischemia. International Journal of Cardiology 2014;175(3):539‐44. - PubMed
Beeres 2007 {published data only}
Beeres 2007a {published data only}
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- Beeres SL, Bax JJ, Dibbets‐Schneider P, Stokkel MP, Fibbe WE, Wall EE, et al. Intramyocardial injection of autologous bone marrow mononuclear cells in patients with chronic myocardial infarction and severe left ventricular dysfunction. American Journal of Cardiology 2007;100(7):1094‐8. [PUBMED: 17884369] - PubMed
Beeres 2007b {published data only}
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- Beeres SL, Bengel FM, Bartunek J, Atsma DE, Hill JM, Vanderheyden M, et al. Role of imaging in cardiac stem cell therapy. Journal of the American College of Cardiology 2007;49(11):1137‐48. [PUBMED: 17367656] - PubMed
Bittencourt 2008 {published data only}
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- Bittencourt MS, Schettert IT, Grupi CJ, Cesar LAM, Krieger JE, Dallan LAO, et al. Resting electrocardiographic variables of patients with severe coronary artery disease undergoing coronary artery bypass graft surgery plus intramyocardial bone marrow cell injection: A one‐year follow up study. Circulation 2008;118(12):E225.
Bolli 2011 {published data only}
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- Bolli R, Chugh A, D'Amario D, Loughran JH, Stoddard MF, Ikram S, et al. Effect of cardiac stem cells in patients with ischemic cardiomyopathy: Interim results of the SCIPIO trial up to 2 years after therapy. American Heart Association 2012 Scientific Sessions and Resuscitation Science Symposium, 2012 November 3‐6, Los Angeles, CA. Circulation 2012;126 (23)(23):2784.
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- Chugh AR, Beache GM, Loughran JH, Mewton N, Elmore JB, Kajstura J, et al. Administration of cardiac stem cells in patients with ischemic cardiomyopathy: The SCIPIO trial surgical aspects and interim analysis of myocardial function and viability by magnetic resonance. Circulation 2012;126(11 (Suppl 1)):S54‐64. - PMC - PubMed
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- NCT00474461. Cardiac stem cell infusion in patients with ischemic cardiomyopathy (SCIPIO). clinicaltrials.gov/ct2/show/NCT00474461 First received 15 May 2007.
Chang 2006 {published data only}
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- Chang SA, Kim HK, Lee HY, Kang HJ, Kim YJ, Zo JH, et al. Restoration of synchronicity of the left ventricular myocardial contraction with stem cell therapy: New insights into the therapeutic implication of stem cell therapy in myocardial infarction. American Heart Association Scientific Sessions 2006 2006 November 12‐15, Chicago, IL. Circulation 2006;114 (18 Suppl):Abstract 2718.
Charwat 2010 {published data only}
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- Charwat S, Lang I, Dettke M, Graf S, Nyolczas N, Hemetsberger R, et al. Effect of intramyocardial delivery of autologous bone marrow mononuclear stem cells on the regional myocardial perfusion. NOGA‐guided subanalysis of the MYSTAR prospective randomised study. Thrombosis and Haemostasis 2010;103(3):564‐71. [PUBMED: 20076851] - PubMed
Chen 2014 {published data only}
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- Chen XM, Cui DY, Zhang M. Clinical observation of stem cell transplantation in patients with acute myocardial infarction complicated with heart failure. Journal of Dalian Medical University 2014;36(2):157‐9.
Chin 2010 {published data only}
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- Chin SP, Poey AE, Chang SK, Wong CY, Lam KH, Cheong SK. Safety and efficacy of autologous mesenchymal stem cells for the treatment of end‐stage dilated cardiomyopathy ‐ a comparison of intracoronary and direct intramyocardial injection. European Society of Cardiology Congress 2010 August 28‐September 1, Stockholm, Sweden. European Heart Journal 2010;31 (17 Suppl 1):79‐80, Abstract P601.
EUCTR2006‐005628‐17‐ES {published data only}
-
- EUCTR2006‐005628‐17‐ES. Open study with blind regulator on the effectiveness of autologous bone marrow mononuclear cells in patients with left ventricular dysfunction after myocardia infarction [Estudio abierto con evaluador ciego de la eficacia de las células mononucleares autólogas de médula ósea en la regeneración muscular y vascular en pacientes con disfunción ventricular izquierda tras infarto de miocardio]. https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2006‐00562... First received 19 February 2007.
EUCTR2009‐017924‐18‐NL {published data only}
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- EUCTR2009‐017924‐18‐NL. Efficacy assessment of repeat intramyocardial injection of autologous bone marrow cells in previously responding no‐option patients with residual refractory angina pectoris and documented ischemia. https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2009‐01792... First received 17 June 2010.
Fuchs 2004 {published data only}
-
- Fuchs S, Kornowski R, Weisz G, Satler LF, Smits PC, Okubagzi P, et al. Transendocardial autologous bone marrow cell transplantation in patients with advanced ischemic heart disease: Final results from a multi‐center feasibility study. Journal of the American College of Cardiology 2004;5 (Suppl A):99A.
Gu 2011 {published data only}
-
- Gu X, Xie Y, Gu J, Sun L, He S, Xu R, et al. Repeated intracoronary infusion of peripheral blood stem cells with G‐CSF in patients with refractory ischemic heart failure ‐ a pilot study. Circulation Journal 2011;75(4):955‐63. [PUBMED: 21325723] - PubMed
Haack‐Sorensen 2013 {published data only}
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- Haack‐Sorensen M, Friis T, Mathiasen AB, Jorgensen E, Hansen L, Dickmeiss E, et al. Direct intramyocardial mesenchymal stromal cell injections in patients with severe refractory angina: one‐year follow‐up. Cell Transplantation 2013;22(3):521‐8. - PubMed
Jimenez‐Quevedo 2008 {published data only}
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- Jimenez‐Quevedo P, Silva GV, Sanz‐Ruiz R, Oliveira EM, Fernandes MR, Angeli F, et al. Diabetic and nondiabetic patients respond differently to transendocardial injection of bone marrow mononuclear cells: Findings from prospective clinical trials in "no‐option" patients. Revista Espanola de Cardiologia 2008;61(6):635‐9. - PubMed
Kang 2006 {published data only}
-
- Kang HJ, Kim MK, Lee HY, Park KW, Lee W, Cho YS, et al. Five‐year results of intracoronary infusion of the mobilized peripheral blood stem cells by granulocyte colony‐stimulating factor in patients with myocardial infarction. European Heart Journal 2012;33(24):3062‐9. - PubMed
-
- Kang HJ, Lee HY, Na SH, Chang SA, Park KW, Kim HK, et al. Differential effect of intracoronary infusion of mobilized peripheral blood stem cells by granulocyte colony‐stimulating factor on left ventricular function and remodeling in patients with acute myocardial infarction versus old myocardial infarction: the MAGIC Cell‐3‐DES randomized, controlled trial. Circulation 2006;114(1 Suppl):I145‐51. [PUBMED: 16820564] - PubMed
Kang 2006b {published data only}
-
- Kang H‐J, Kim H‐S, Na S‐H, Zhang S‐Y, Kang WJ, Youn T‐J, et al. Six months follow up results of "granulocytes‐colony stimulating factor" based stem cell therapy in patients with myocardial infarction: MAGIC cell randomized controlled trial. Korean Circulation Journal 2006;36(2):99‐107.
Karantalis 2014 {published data only}
-
- Karantalis V, DiFede DL, Gerstenblith G, Pham S, Symes J, Zambrano JP, et al. Autologous mesenchymal stem cells produce concordant improvements in regional function, tissue perfusion, and fibrotic burden when administered to patients undergoing coronary artery bypass grafting. American Heart Association; 2013 Scientific Sessions and Resuscitation Science Symposium, 2013 November 16‐20, Dallas, TX. Circulation 2013;128 (22 Suppl 1). - PMC - PubMed
-
- Karantalis V, DiFede DL, Gerstenblith G, Pham S, Symes J, Zambrano JP, et al. 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. Circulation Research 2014;114(8):1302‐10. - PMC - PubMed
-
- NCT00587990. Prospective randomized study of mesenchymal stem cell therapy in patients undergoing cardiac surgery (PROMETHEUS). clinicaltrials.gov/ct2/show/NCT00587990 First received 2 January 2008.
Koestering 2005 {published data only}
-
- Brehm M, Koestering M, Zeus T, Bartsch T, Turan G, Antke C, et al. Improvement of heart function in chronic coronary heart disease with chronic myocardial infarction: Controlled study with intracoronary autologous mononuclear bone marrow cell transplantation (IACT‐Study). Circulation 2005;111 (13):1721.
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- Koestering M, Bartsch T, Brehm M, Zeus T, Turan RG, Schannwell CM. Long term follow‐up of improvement of human infarcted heart muscle by intracoronary autologous mononuclear bone marrow cells in chronic coronary artery disease (IACT‐Study). European Heart Journal 2006;27 (Suppl 1):281‐2.
-
- Koestering M, Bartsch T, Zeus T, Brehm M, Scharmwell CM, Strauer BE. Long term (2,5 year's) follow‐up by intracoronary infusion of autologous mononuclear bone marrow cells in chronic coronary artery disease after is associated with improvement of left ventricular function in human infarcted heart muscle (IACT‐Study). Circulation 2007;116 (16 Suppl):289. Abstract 1406.
-
- Koestering M, Brehm M, Zeus T, Antke C, Koegler G, Wernet P, et al. Regeneration of human heart function in chronic coronary heart disease with chronic myocardial infarction: Controlled study with intracoronary autologous mononuclear bone marrow cell transplantation. European Heart Journal 2005;26 (Suppl 1):532.
-
- Koestering M, Zeus T, Brehm M, Bartsch T, Scharmwell C, Strauer BE. Regeneration of human infarcted heart muscle in chronic coronary artery disease after myocardial infarction: Controlled study with intracoronary autologous mononuclear bone marrow cell transplantation (IACT‐study). Circulation 2007;116 (Suppl):767‐8. Abstract 3400.
Lai 2009 {published data only}
-
- Ang KL, Lai VK, Rathbone WE, Harvey NH, Galinanes M. Randomized controlled trial on the cardioprotective effect of bone marrow cells in patients undergoing coronary artery bypass graft surgery. European Journal of Heart Failure 2009;8:ii707. - PubMed
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- Lai VK, Ang KL, Rathbone W, Harvey NJ, Galinanes M. Randomized controlled trial on the cardioprotective effect of bone marrow cells in patients undergoing coronary bypass graft surgery. European Heart Journal 2009;30(19):2354‐9. [PUBMED: 19561024] - PubMed
Lee 2015 {published data only}
-
- ISRCTN26002902. Intra‐coronary transfusion of autologous CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease (CAD) and non‐candidates for coronary artery intervention. www.isrctn.com/ISRCTN26002902 First received 12 August 2013.
-
- ISRCTN72853206. Intra‐coronary transfusion of autologous CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease and non candidates for coronary artery intervention. www.isrctn.com/ISRCTN72853206 First received 30 January 2012.
-
- Lee F, Chen Y, Chua S, Fu M, Pei S, Yip H. Intra‐coronary transfusion of circulatory derived CD34+ cells improves left ventricular function in patients with diffuse coronary artery disease and non candidates for coronary artery intervention. 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation, ISHLT 2015, 2015 April 15‐18, Nice, France. Journal of Heart and Lung Transplantation 2015;34 (Suppl 1):S183.
-
- Lee FY, Chen YL, Sung PH, Ma MC, Pei SN, Wu CJ, et al. Intracoronary transfusion of circulation‐derived CD34+ cells improves left ventricular function in patients with end‐stage diffuse coronary artery disease unsuitable for coronary intervention. Critical Care Medicine 2015;43(10):2117‐32. - PubMed
Makkar 2011 {published data only}
-
- Makkar R, Smith RR, Cheng K, Malliaras K, Marban L, Thomson L, et al. The CADUCIUS (cardiosphere‐derived autologous stem cells to reverse ventricular dysfunction) trial. American Heart Association's Scientific Sessions 2011, 2011 November 12‐16, Orlando, FL. Circulation 2011;124 (21):2373.
Mann 2015 {published data only}
-
- Mann I, Rodrigo SF, Ramshorst J, Beeres SL, Dibbets‐Schneider P, Roos A, et al. Repeated intramyocardial bone marrow cell injection in previously responding patients with refractory angina again improves myocardial perfusion, anginal complaints and quality of life. Circulation: Cardiovascular Interventions 2015;8:8. - PubMed
Maroto 2010 {published data only}
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- Maroto L, San Roman A, Stefano S, Rey J, Fulquet E, Arevalo A, et al. Transplantation of unselected autologous bone marrow mononuclear cells in subacute myocardial infarction. 59th International Congress of the European Society for Cardiovascular Surgery, ESCVS 2010, 2010 April 15‐18, Izmir, Turkey. Interactive Cardiovascular and Thoracic Surgery 2010;10:S170‐1.
Maureira 2012 {published data only}
-
- Maureira P, Tran N, Djaballah W, Angioi M, Bensoussan D, Didot N, et al. Residual viability is a predictor of the perfusion enhancement obtained with the cell therapy of chronic myocardial infarction: a pilot multimodal imaging study. Clinical Nuclear Medicine 2012;37(8):738‐42. [PUBMED: 22785499] - PubMed
Mocini 2006 {published data only}
-
- Mocini D, Staibano M, Mele L, Giannantoni P, Menichella G, Colivicchi F, et al. Autologous bone marrow mononuclear cell transplantation in patients undergoing coronary artery bypass grafting. American Heart Journal 2006;151(1):192‐7. - PubMed
Nagaya 2007 {published data only}
-
- Nagaya N, Ohgushi H, Shimizu W, Yamagishi M, Noguchi T, Noda T, et al. Clinical trial of autologous bone marrow mesenchymal stem cell transplantation for severe chronic heart failure. Circulation 2007;116 (16 Suppl):453.
NCT00285454 {published data only}
-
- NCT00285454. Cell repair in heart failure. clinicaltrials.gov/show/NCT00285454 First received 27 January 2006.
NCT00289822 {published data only}
-
- NCT00289822. Cell therapy for coronary heart disease. clinicaltrials.gov/show/NCT00289822 First received 8 February 2006.
NCT00362388 {published data only}
-
- NCT00362388. Cell therapy in chronic ischemic heart disease. clinicaltrials.gov/show/NCT00362388 First received 8 August 2006.
NCT01074099 {published data only}
-
- NCT01074099. Feasibility study of BMAC enhanced CABG. clinicaltrials.gov/show/NCT01074099 First received 1 February 2010.
NCT01337011 {published data only}
-
- NCT01337011. Intra‐coronary versus intramyocardial application of enriched CD133pos autologous bone marrow derived stem cells (AlsterMACS). clinicaltrials.gov/show/NCT01337011 First received 14 April 2011.
NCT01666132 {published data only}
-
- NCT01666132. METHOD ‐ Bone marrow derived mononuclear cells in chronic ischemic disease. clinicaltrials.gov/show/NCT01666132 First received 27 June 2011.
NCT01693042 {unpublished data only}
-
- NCT01693042. Compare the effects of single versus repeated intracoronary application of autologous bone marrow‐derived mononuclear cells on mortality in patients with chronic post‐infarction heart failure (REPEAT). clinicaltrials.gov/ct2/show/NCT01693042 First received 19 September 2012.
NCT01721902 {published data only}
-
- NCT01721902. Stem cell implantation in patients undergoing CABG. clinicaltrials.gov/show/NCT01721902 First received 1 October 2012.
Perin 2003 {published data only}
-
- Dohmann HFR, Perin EC, Borojevic H, Sousa ALS, Silva SA, Carvalho AC, et al. Transendocardial autologous bone‐marrow cell transplantation in severe, chronic ischaemic heart failure: Prospective controlled study. European Heart Journal 2003;24 (Suppl):715.
-
- Dohmann HFR, Perin EC, Borojevic R, Silva SA, Souza ALS, Silva GV, et al. Sustained improvement in symptoms and exercise capacity up to six months after autologous transendocardial transplantation of bone marrow mononuclear cells in patients with severe ischemic heart disease. Arquivos Brasileiros de Cardiologia 2005;84(5):360‐6. - PubMed
-
- Perin EC, Dohmann HF, Borojevic R, Silva SA, Sousa AL, Mesquita CT, et al. Transendocardial, autologous bone marrow cell transplantation for severe, chronic ischemic heart failure. Circulation 2003;107(18):2294‐302. [PUBMED: 12707230] - PubMed
-
- Perin EC, Dohmann HF, Borojevic R, Silva SA, Sousa AL, Silva GV, et al. Improved exercise capacity and ischemia 6 and 12 months after transendocardial injection of autologous bone marrow mononuclear cells for ischemic cardiomyopathy. Circulation 2004;110(11 Suppl 1):II213‐8. [PUBMED: 15364865] - PubMed
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Peruga 2009 {published data only}
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- Peruga J, Plewka M, Kasprzak J, Jezewski T, Wierzbicka A, Robak T, et al. Intracoronary administration of stem cells in patients with acute myocardial infarction ‐ angiographic follow‐up. Kardiologia Polska 2009;67(5):477‐84. [PUBMED: 19521932] - PubMed
Poglajen 2013 {published data only}
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- Poglajen G, Sever M, Cukjati M, Cernelc P, Knezevic I, Zemljic G, et al. Effects of transendocardial CD34+ cell transplantation in patients with ischemic cardiomyopathy. Circulation: Cardiovascular Interventions 2014;7(4):552‐9. - PubMed
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- Poglajen G, Sever M, Mali P, Haddad F, Wu JC, Vrtovec B. Effects of transendocardial CD34+ stem cell transplantation in patients with ischaemic cardiomyopathy. American Heart Association 2013 Scientific Sessions and Resuscitation Science Symposium, 2013 November 16‐20, Dallas, TX. Circulation 2013;128 (22 Suppl 1).
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- Poglajen G, Zemljic G, Sever M, Cukjati M, Haddad F, Wu JC, et al. Comparison of clinical effects following multi‐site versus single‐site CD34+ cell injections in patients with ischemic cardiomyopathy. American Heart Association's 2014 Scientific Sessions and Resuscitation Science Symposium, 2014 November 15‐18, Chicago, IL. Circulation 2014;130.
Pokushalov 2011 {published data only}
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- Pokushalov E, Romanov A, Corbucci G, Prohorova D, Chernyavsky A, Larionov P, et al. Cardiac resynchronization therapy and bone marrow cell transplantation in patients with ischemic heart failure and electromechanical dyssynchrony: a randomized pilot study. Journal of Cardiovascular Translational Research 2011;4(6):767‐78. [PUBMED: 21547598] - PubMed
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- Pokushalov E, Romanov A, Prohorova D, Artemenko S, Cheriniavskiy A, Karaskov A, et al. Cardiac resynchronization therapy in patients with ischemic heart failure after bone marrow cell transplantation. Journal of the American College of Cardiology 2011;57 (14 Suppl 1):Abstract E103.
Premer 2014 {published data only}
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- Premer C, Blum A, Bellio M, Schulman IH, Sierra J, Delgado C, et al. Intracardiac mesenchymal stem cells restore endothelial function in heart failure by stimulating the release of endothelial progenitor cells. American Heart Association's 2014 Scientific Sessions and Resuscitation Science Symposium, 2014 November 15‐18, Chicago, IL. Circulation 2014;130.
Qin 2015 {published data only}
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- Qin J, Guo Y, Chen X, Liu X. Intracoronary cardiosphere‐derived cells for heart regeneration after myocardial infarction. 26th Great Wall International Congress of Cardiology, Asia Pacific Heart Congress 2015 and the International Congress of Cardiovascular Prevention and Rehabilitation 2015, 2015 October 29‐November 1, Beijing, China. Journal of the American College of Cardiology 2015;66(16 (Suppl 1)):C30.
Rivas‐Plata 2010 {published data only}
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- Rivas‐Plata A, Castillo J, Pariona M, Chunga A. Bypass grafts and cell transplant in heart failure with low ejection fraction. Asian Cardiovascular & Thoracic Annals 2010;18(5):425‐9. [PUBMED: 20947595] - PubMed
Shen 2007 {published data only}
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- Shen ZY, Yu GP, Hu YQ. The experimental study on the effect to cardiac function by intramyocardial transplantation of mobilized autologous bone marrow stem cells after myocardial infarction. Xenotransplantation 2007;14(5):539.
Stamm 2007a {published data only}
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- Stamm C, Kleine HD, Choi YH, Dunkelmann S, Lauffs JA, Lorenzen B, et al. Intramyocardial delivery of CD133+ bone marrow cells and coronary artery bypass grafting for chronic ischemic heart disease: safety and efficacy studies. Journal of Thoracic and Cardiovascular Surgery 2007;133(3):717‐25. [PUBMED: 17320570] - PubMed
Suncion 2014 {published data only}
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- Suncion VY, Ghersin E, Fishman JE, Zambrano JP, Karantalis V, Mandel N, et al. Does transendocardial injection of mesenchymal stem cells improve myocardial function locally or globally? An analysis from the percutaneous stem cell injection delivery effects on neomyogenesis (POSEIDON) randomized trial. Circulation Research 2014;14(8):1292‐301. - PMC - PubMed
Takehara 2012 {published data only}
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- Takehara N, Ogata T, Nakata M, Kami D, Nakamura T, Matoba S, et al. The ALCADIA (autologous human cardiac‐derived stem cell to treat ischemic cardiomyopathy) trial. Circulation 2012;126(23):2783.
Tuma 2010 {published data only}
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- Tuma J, Fernandez R, Cruz C, Carrillo A, Erchilla J, Inga L, et al. Long term benefit of autologous bone marrow transplantation by retrograde technique in terminal heart failure (LIBERTY study). Journal of the American College of Cardiology 2010;56 (13 Suppl 1):B71.
Tuma 2011 {published data only}
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- Tuma J, Carrasco A, Vina RF, Chirinos S, Curz C, Patel AN. Five year follow‐up of coronary sinus delivery of bone marrow cells for congestive heart failure. 20th Annual Meeting of the International Society for Cell Therapy, ISCT 2014, 2014 April 23‐26, Paris, France. Cytotherapy 2014;16:S42.
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- Tuma J, Carrasco A, Winters AA, Chirinos S, Patel AN. Long term follow‐up of coronary sinus delivery of bone marrow cells for congestive heart failure. 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation, ISHLT 2015, 2015 April 15‐18, Nice, France. Journal of Heart and Lung Transplantation 2015;34 (4 Suppl 1):S181‐2.
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- Tuma J, Fernandez‐Vina R, Carrasco A, Castillo J, Cruz C, Carrillo A, et al. Safety and feasibility of percutaneous retrograde coronary sinus delivery of autologous bone marrow mononuclear cell transplantation in patients with chronic refractory angina. Journal of Translational Medicine 2011;9:183. [PUBMED: 22029669] - PMC - PubMed
Vicario 2004 {published data only}
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- Vicario J, Campo C, Piva J, Faccio F, Gerardo L, Becker C, et al. One‐year follow‐up of transcoronary sinus administration of autologous bone marrow in patients with chronic refractory angina. Cardiovascular Revascularization Medicine: including Molecular Interventions 2005;6(3):99‐107. - PubMed
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- Vicario J, Campos C, Piva J, Faccio F, Gerardo L, Becker C, et al. Transcoronary sinus administration of autologous bone marrow in patients with chronic refractory stable angina Phase 1. Cardiovascular Radiation Medicine 2004;5(2):71‐6. [PUBMED: 15464943] - PubMed
Vrtovec 2015 {published data only}
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- Vrtovec B, Poglajen G, Zemljic G, Sever M, Cukhati M, Haddad F, et al. Response to CD34+ cell therapy is associated with myocardial scar burden in patients with ischemic and non‐ischemic chronic heart failure. 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation, ISHLT 2015, 2015 April 14‐18, Nice, France. Journal of Heart and Lung Transplantation 2015;34 (Suppl 1):S90‐1.
Wang 2006 {published data only}
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- Wang WM, Sun NL, Liu J, Zhang P, Liu KY, Wang Q, et al. Effects of intracoronary autologous bone marrow mononuclear cells transplantation in patients with anterior myocardial infarction. Zhonghua Xin Xue Guan Bing Za Zhi 2006;34(2):103‐6. [PUBMED: 16626572] - PubMed
References to studies awaiting assessment
Ahmadi 2010 {published data only}
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- Ahmadi S, Soleymani M, Sahebjam M, Zorofian A, Ahmadbeigi N, Karimi A, et al. Treatment of heart failure with expanded autologous bone marrow‐derived mesenchymal/CD133+ stem/progenitor cell transplantation during CABG. 59th International Congress of the European Society for Cardiovascular Surgery, ESCVS 2010, 2010 April 15‐18, Izmir, Turkey. Interactive Cardiovascular and Thoracic Surgery 2010;10 (Suppl 1):S80.
Ahmadi 2015 {published data only}
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- Ahmadi SH, Soleymani M, Sahebjam M, Karimi AA, Madani CM. Which stem cell type is more efficient as an adjunctive to surgical treatment of severe ischemic heart failure: expanded mesenchymal or recycling stem cells? International Academy of Cardiology 20th World Congress on Heart Disease Annual Scientific Sessions 2015, 2015 July 25‐27, Vancouver, Canada. Cardiology (Switzerland) 2015;131:100.
Cuzzola 2007 {published data only}
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- Cuzzola M, Irrera G, Pontari A, Callea I, Pucci G, Martinelli G, et al. Progenitor cell trafficking in patients with infarcted myocardium undergoing autologous bone marrow mononuclear cell injection. Interim analysis of a double blind randomised phase II clinical trial. European Group for Blood and Marrow Transplantation Annual Congress, 2007 March 25‐28, Lyon, France. Bone Marrow Transplantation 2007;39 (Suppl 1s):S215.
Grynberg 2008 {published data only}
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- Grynberg L, Balino NP, Riccitelli M, Dupont L, Caccione R, Traverso S, et al. Intracoronary bone marrow stem cell transplantation: Feasibility, safety, and effect on ventricular function and myocardial perfusion. Circulation 2008;118(12):E482‐3.
Jie 2014 {published data only}
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- Jie Q, Wang X, Bai M, Huang S, Qin J. A prospective study on autologous bone marrow mononuclear cell transplantation in ischemic heart failure. 25th Great Wall International Congress of Cardiology, Asia Pacific Heart Congress 2014, and the International Congress Cardiovascular Prevention and Rehabilitation 2014, 2014 October 16‐19, Beijing, China. Journal of the American College of Cardiology 2014;64 (Suppl 1):C182.
Kakuchaya 2011 {published data only}
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- Kakuchaya T. Influence of bone‐marrow derived progenitor stem cells on cardiac remodelling in a placebo‐controlled clinical trial involving patients with congestive heart failure. 20th World Congress of the World Society of Cardio‐Thoracic Surgeons, WSCTS, 2010 October 20‐23, Chennai, India. Heart Surgery Forum 2010;13:S121.
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- Kakuchaya T, Golukhova E, Eremeeva M, Chigogidze N, Aslanidi I, Nikitina T, et al. Bone‐marrow progenitor stem cells for the treatment of patients with congestive heart failure of different etiology in a placebo controlled clinical trial. 60th International Congress of the European Society for Cardiovascular Surgery, ESCVS 2011, 2011 May 20‐22, Moscow, Russia. Interactive Cardiovascular and Thoracic Surgery 2011;12:S68.
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- Kakuchaya T, Golukhova E, Eremeeva M, Chigogidze N, Aslanidi I, Shurupove I, et al. Accurate design of randomized placebo‐controlled clinical trials for assessment of stem cell effects on cardiac regeneration. European Heart Journal 2011;32:290: Abstract P1758.
Minjie 2011 {published data only}
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- Minjie L, Shihua Z, Sheng L, Shiliang J, Gang Y. Effects of autologous bone marrow mononuclear cells transplantation through coronary artery bypass grafting in patients with old myocardial infarction assessed by MRI: A randomised, double‐blind, placebo‐controlled pilot trial. Heart 2011;97:A137‐8.
Pourrajab 2013 {published data only}
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- Pourrajab F, Hekmatimoghaddam SH, Forouzannia SK, Baqhiyazdi M, Babaeezarch M, Ebrahimi H. Design of a combinatorial and feasible protocol for autologous bone marrow stem cell transplantation in patients candidate for CABG. 9th Congress on Stem Cell Biology and Technology of the Royan International Twin Congress, 2013 September 4‐6, Tehran, Iran. Cell Journal 2013;15:61, Abstract Ps96.
Stefanelli 2015 {published data only}
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- Stefanelli GG, Perro F, Trevisan D, Olaru A, Bia E, Meli M, et al. One step direct subendocardial implant of autologous stem cells during left ventricular restoration for ischemic heart failure. Heart Failure 2015 and the 2nd World Congress on Acute Heart Failure, 2015 May 23‐26, Seville, Spain. European Journal of Heart Failure 2015;17:410.
Zverev 2006 {published data only}
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- Zverev O, Boldueva S, Nemkov A, Shloydo E, Tsurupa S, Rigkova D, et al. Improvement of cardiomyocyte function after transplantation of autologous bone marrow mesenchymal stem cells in patients with non‐acute ischemic heart disease. World Congress of Cardiology, 2006 September 2‐6, Barcelona, Spain. European Heart Journal 2006;27 (Suppl 1):276: Abstract P1663.
References to ongoing studies
EUCTR2009‐016364‐36‐NL {published data only}
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- EUCTR2009‐016364‐36‐NL. Injection of autologous bone marrow cells into damaged myocardium of no‐option patients with ischemic heart failure: a randomized placebo controlled trial. https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2009‐01636... First received 17 December 2009.
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- NTR2516. Injection of autologous bone marrow cells into damaged myocardium of no‐option patients with ischemic heart failure, a randomized placebo‐controlled trial. apps.who.int/trialsearch/trial.aspx?trialid=NTR2516 (accessed 7 September 2016).
ISRCTN71717097 {published data only}
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- ISRCTN71717097. Bone‐marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end‐stage heart failure: a randomised blinded controlled trial (TransACT 2). www.isrctn.com/ISRCTN71717097 First received 27 July 2009.
ISRCTN75217135 {published data only}
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- ISRCTN75217135. A pilot study to evaluate the efficacy of combined transplantation of progenitor cells and coronary artery bypass grafting (TOPCABG) N/A. www.isrctn.com/ISRCTN75217135 First received 30 September 2004.
NCT00690209 {published data only}
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- NCT00690209. By pass surgery with stem cell therapy in chronic ischemic cardiopathy. clinicaltrials.gov/show/NCT00690209 First received 30 May 2008.
NCT00790764 {published data only}
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- NCT00790764. Phase II combination stem cell therapy for the treatment of severe coronary ischemia (CI). clinicaltrials.gov/show/NCT00790764 First received 12 November 2008.
NCT00820586 {published data only}
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- NCT00820586. Intramyocardial delivery of autologous bone marrow. clinicaltrials.gov/show/NCT00820586 First received 8 January 2009.
NCT00950274 {published data only}
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- Donndorf P, Kaminski A, Tiedemann G, Kindt G, Steinhoff G. Validating intramyocardial bone marrow stem cell therapy in combination with coronary artery bypass grafting, the PERFECT Phase III randomized multicentre trial: study protocol for a randomized controlled trial. Trials 2012;13:99. - PMC - PubMed
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- NCT00950274. Intramyocardial transplantation of bone marrow stem cells in addition to coronary artery bypass graft (CABG) surgery. clinicaltrials.gov/show/NCT00950274 First received 30 July 2009.
NCT01033617 {published data only}
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- NCT01033617. IMPACT‐CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing CABG. clinicaltrials.gov/show/NCT01033617 First received 14 December 2009.
NCT01214499 {published data only}
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- NCT01214499. Prospective, controlled and randomized clinical trial on cardiac cell regeneration with laser and autologous bone marrow stem cells, in patients with coronary disease and refractory angina. clinicaltrials.gov/show/NCT01214499 First received 3 October 2010.
NCT01267331 {published data only}
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- NCT01267331. Cell therapy in patients with chronic ischemic heart disease undergoing cardiac surgery. clinicaltrials.gov/show/NCT01267331 First received 23 December 2010.
NCT01354678 {published data only}
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- NCT01354678. Intramyocardial multiple precision injection of bone marrow mononuclear cells in myocardial ischemia (IMPI). clinicaltrials.gov/show/NCT01354678 First received 13 May 2011.
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- Shlyakhto EV, Lebedev DS, Kryzhanovsky DV, Anisimov SV, Kozlenok AV, Berezina AV, et al. First experience of the study "Intramyocardial multiple precision administration of mononuclear bone marrow cells in the treatment of myocardial ischemia". Kardiologiia 2013;53(3):4‐8. - PubMed
NCT01467232 {published data only}
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- NCT01467232. IMPACT‐CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting. clinicaltrials.gov/show/NCT01467232 First received 28 October 2011.
NCT01508910 {published data only}
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- NCT01508910. Efficacy and safety of targeted intramyocardial delivery of auto CD34+ stem cells for improving exercise capacity in subjects with refractory angina (RENEW). clinicaltrials.gov/show/NCT01508910 First received 10 January 2012.
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- Povsic TJ, Junge C, Nada A, Schatz RA, Harrington RA, Davidson CA, et al. A phase 3, randomized, double‐blinded, active‐controlled, unblinded standard of care study assessing the efficacy and safety of intramyocardial autologous CD34+ cell administration in patients with refractory angina: Design of the RENEW study. American Heart Journal 2013;165(6):854‐61. - PubMed
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- Povsic TJ, Losordo DW, Story K, Junge CE, Schatz RA, Harrington RA, et al. A phase 3, randomized, partially blinded, active‐controlled, study assessing the efficacy and safety of intramyocardial autologous CD34+ cell administration in patients with refractory angina: Design of the RENEW study. American Heart Association 2012 Scientific Sessions and Resuscitation Science Symposium, 2012 November 3‐6, Los Angeles, CA. Circulation 2012;126 (21 Suppl 1):Abstract 11777.
NCT01615250 {published data only}
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- NCT01615250. Implantation of peripheral stem cells in patient with ischemic cardiomyopathy (ISCIC). clinicaltrials.gov/show/NCT01615250 First received 6 June 2012.
NCT01660581 {published data only}
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- NCT01660581. Intracardiac CD133+ cells in patients with no‐option resistant angina (Regent Vsel). clinicaltrials.gov/show/NCT01660581 First received 6 August 2012.
NCT01720888 {published data only}
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- NCT01720888. Intracoronary autologous mesenchymal stem cells implantation in patients with ischemic dilated cardiomyopathy. clinicaltrials.gov/show/NCT01720888 First received 1 November 2012.
NCT01727063 {published data only}
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- NCT01727063. Cell therapy in severe chronic ischemic heart disease (MiHeart). clinicaltrials.gov/show/NCT01727063 First received 12 November 2012.
NCT01758406 {published data only}
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- NCT01758406. Transplantation of autologous cardiac stem cells in ischemic heart failure. clinicaltrials.gov/show/NCT01758406 First received 24 December 2012.
NCT01768702 {published data only}
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- EUCTR2011_001117‐13‐GB. Research study aiming at investigating the potential effectiveness and safety of a treatment for chronic advanced heart failure of ischemic origin. The treatment is based on patient own stem cells that will be collected and guided to the cardiac cells lineage before being injected into the heart muscle. https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2011‐00111... First received 11 July 2012.
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- NCT01768702. Safety and efficacy of autologous cardiopoietic cells for treatment of ischemic heart failure. (CHART‐1). clinicaltrials.gov/show/NCT01768702 First received 21 December 2012.
NCT02022514 {published data only}
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- EUCTR2013‐000915‐26‐ES. Clinical trial phase III single‐center, open‐label efficacy of intracoronary infusion of bone marrow mononuclear cells in patients with occlusion autologous chronic coronary revascularization and ventricular dysfunction previously [Ensayo Clínico Fase III Unicéntrico, Abierto, Aleatorizado sobre eficacia de la Infusión Intracoronaria de células Mononucleadas de Médula Ósea Autóloga en Pacientes Con Oclusión Coronaria Crónica y Disfunción Ventricular previamente revascularizados]. https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2013‐00091... First received 9 April 2013.
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- NCT02022514. Intracoronary infusion of mononuclear cells autologous bone marrow in patients with chronic coronary occlusion and ventricular dysfunction, previously revascularized. clinicaltrials.gov/show/NCT02022514 First received 20 December 2013.
NCT02059512 {published data only}
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- NCT02059512. Autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. clinicaltrials.gov/show/NCT02059512 First received 1 February 2014.
NCT02317458 {published data only}
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- NCT02317458. Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART‐2) Trial. clinicaltrials.gov/show/NCT02317458 First received 9 December 2014.
NCT02362646 {published data only}
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- NCT02362646. Safety & efficacy of intramyocardial injection of mesenchymal precursor cells on myocardial function in LVAD recipients. clinicaltrials.gov/show/NCT02362646 First received 9 February 2015.
NCT02438306 {published data only}
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- NCT02438306. CardiAMP™ Heart Failure Trial. clinicaltrials.gov/ct2/show/NCT02438306 First received 5 May 2015.
NCT02462330 {published data only}
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- NCT02462330. Administration of mesenchymal stem cells in patients with chronic ischemic cardiomyopathy (MESAMI2). clinicaltrials.gov/ct2/show/NCT02462330 First received 27 May 2015.
NCT02501811 {published data only}
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- NCT02501811. Combination of Mesenchymal and C‐kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure (CONCERT‐HF). clinicaltrials.gov/ct2/show/NCT02501811 First received 15 July 2015.
NCT02503280 {published data only}
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- NCT02503280. The Transendocardial Autologous Cells (hMSC or hMSC and hCSC) in Ischemic Heart Failure Trial (TAC‐HFT II). clinicaltrials.gov/ct2/show/NCT02503280 First received 4 May 2015.
NCT02504437 {published data only}
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- NCT02504437. Therapy of Preconditioned Autologous BMMSCs for Patients With Ischemic Heart Disease (TPAABPIHD). clinicaltrials.gov/ct2/show/NCT02504437 First received 14 July 2015.
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