Safety and feasibility of intramyocardial versus intracoronary delivery of autologous cell therapy in advanced heart failure: The REGENERATE-IHD pilot study

Regenerative Medicine

Volumn 9, Issue 3, 2014, Pages 269-278

  Mozid, Abdul ^a   Yeo, Chia ^a   Arnous, Samer ^a   Ako, Emmanuel ^a   Saunders, Natalie ^b   Locca, Didier ^a   Brookman, Pat ^a   Archbold, R Andrew ^a   Rothman, Martin ^a   Mills, Peter ^a   Agrawal, Samir ^b   Martin, John ^c   Mathur, Anthony ^d  

^a LONDON CHEST HOSPITAL   (United Kingdom)

^b BARTS HEALTH NHS TRUST   (United Kingdom)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

Autologous bone marrow derived stem progenitor cells; Chronic ischemic heart failure; Granulocyte colony stimulating factor; Intracoronary delivery; Intramyocardial delivery

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; BRAIN NATRIURETIC PEPTIDE; PEPTIDE FRAGMENT; PRO-BRAIN NATRIURETIC PEPTIDE (1-76);

ADULT; AGED; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; BLEEDING; BONE PAIN; CELL TRANSFER; CONTROLLED STUDY; FEASIBILITY STUDY; FEMALE; FEVER; HEART ARRHYTHMIA; HEART ATRIUM FIBRILLATION; HEART BLOCK; HEART DISEASE; HEART FAILURE; HEART VENTRICLE TACHYCARDIA; HEMATOPOIETIC STEM CELL; HUMAN; HUMAN CELL; INTERMETHOD COMPARISON; INTRACORONARY DELIVERY; INTRAMYOCARDIAL DELIVERY; MAJOR CLINICAL STUDY; MALE; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SAFETY; STEM CELL MOBILIZATION; TREATMENT OUTCOME; AUTOTRANSPLANTATION; BONE MARROW TRANSPLANTATION; DRUG ADMINISTRATION ROUTE; HEART; HEART MUSCLE; PROCEDURES;

BONE MARROW TRANSPLANTATION; DRUG ADMINISTRATION ROUTES; GRANULOCYTE COLONY-STIMULATING FACTOR; HEART; HEART FAILURE; HUMANS; MYOCARDIUM; NATRIURETIC PEPTIDE, BRAIN; PEPTIDE FRAGMENTS; PILOT PROJECTS; TRANSPLANTATION, AUTOLOGOUS;

EID: 84902584256     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.14.3     Document Type: Article

References (18)

1. Assmus B, Honold J, Schachinger V et al. Transcoronary transplantation of progenitor cells after myocardial infarction. N. Engl. J. Med. 355, 1222-1232 (2006).
2. Strauer BE, Brehm M, Zeus T et al. Regeneration of human infarcted heart muscle by intracoronary autologous bone marrow cell transplantation in chronic coronary artery disease: The IACT study. J. Am. Coll. Cardiol. 46, 1651-1658 (2005).
3. Strauer B, Brehm M, Zeus T et al. Repair of infarcted myocardium by autologous intracoronary mononuclear bone marrow cell transplantation in humans. Circulation 106, 1913-1918 (2002).
4. Perin EC, Dohmann HF, Borojevic R et al. Improved exercise capacity and ischemia 6 and 12 months after transendocardial injection of autologous bone marrow mononuclear cells for ischemic cardiomyopathy. Circulation 110(11 Suppl. 1), II213-II218 (2004).
5. Joseph J, Rimawi A, Mehta P et al. Safety and effectiveness of granulocyte-colony stimulating factor in mobilizing stem cells and improving cytokine profile in advanced chronic heart failure. Am. J. Cardiol. 97, 681-684 (2006).
6. Bartunek J, Dimmeler S, Drexler H et al. The consensus of the task force of the European Society of Cardiology concerning the clinical investigation of the use of autologous adult stem cells for repair of the heart. Eur. Heart J. 27, 1338-1340 (2006).
7. Orlic D, Kajstura J, Chimenti S, Jakoniuk I. Bone marrow cells regenerate infarcted myocardium. Nature 410, 701-705 (2001).
8. Yeo C, Mathur A. Autologous bone marrow-derived stem cells for ischemic heart failure: REGENERATE-IHD trial. Regen. Med. 4, 119-127 (2009).
9. Yeo C, Saunders N, Locca D et al. Ficoll-Paque versus Lymphoprep: A comparative study of two density gradient media for therapeutic bone marrow mononuclear cell preparations. Regen. Med. 4, 689-696 (2009).
10. Perin EC, Silva GV, Sarmento-Leite R et al. Assessing myocardial viability and infarct transmurality with left ventricular electromechanical mapping in patients with stable coronary artery disease: Validation by delayed-enhancement magnetic resonance imaging. Circulation 106, 957-961 (2002).
11. Smits PC, van Geuns R-JM, Poldermans D et al. Catheter-based intramyocardial injection of autologous skeletal myoblasts as a primary treatment of ischemic heart failure: Clinical experience with six-month follow-up. J. Am. Coll. Cardiol. 42, 2063-2069 (2003).
12. Huttmann A, Duhrsen U, Stypmann J et al. Granulocyte colony-stimulating factor-induced blood stem cell mobilisation in patients with chronic heart failure-feasibility, safety and effects on exercise tolerance and cardiac function. Basic Res. Cardiol. 101, 78-86 (2006).
13. Leone AM, Giannico MB, Bruno I et al. Safety and efficacy of G CSF in patients with ischemic heart failure: The CORNER (Cell Option For Recovery in the Non-Eligible Patients for Revascularization) study. Int. J. Cardiol. 150(1), 75-78 (2011).
14. Honold J, Lehmann R, Heeschen C et al. Effects of granulocyte colony simulating factor on functional activities of endothelial progenitor cells in patients with chronic ischemic heart disease. Arterioscler. Thromb. Vasc. Biol. 26, 2238-2243 (2006).
15. Losordo DW, Henry TD, Davidson C et al. Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ. Res. 109(4), 428-436 (2011).
16. Hou D, Youssef EA, Brinton TJ et al. Radiolabeled cell distribution after intramyocardial, intracoronary, and interstitial retrograde coronary venous delivery: Implications for current clinical trials. Circulation 112(Suppl. 9), I150-I156 (2005).
17. Ang KL, Chin D, Leyva F et al. Randomized, controlled trial of intramuscular or intracoronary injection of autologous bone marrow cells into scarred myocardium during CABG versus CABG alone. Nat. Clin. Pract. Cardiovasc. Med. 5, 663-670 (2008).
18. Pokushalov E, Romanov A, Chernyavsky A et al. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: A randomized study. J. Cardiovasc. Transl. Res. 3, 160-168 (2010).