Controlled release systems of angiogenic growth factors for cardiovascular diseases

Expert Opinion on Drug Delivery

Volumn 4, Issue 6, 2007, Pages 635-649

  Esaki, Jiro ^a   Marui, Akira ^a   Tabata, Yasuhiko ^b   Komeda, Masashi ^a  

^a KYOTO UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b KYOTO UNIVERSITY   (Japan)

Author keywords

Clinical trial; Controlled release system; Gelatin; Growth factor; Therapeutic angiogenesis

Indexed keywords

ADENOVIRUS VECTOR; AGAROSE; ALGINIC ACID; ANGIOGENIC FACTOR; ANTIANGINA PECTORIS AGENT; FIBROBLAST GROWTH FACTOR; FIBROBLAST GROWTH FACTOR 1; FIBROBLAST GROWTH FACTOR 2; FIBROBLAST GROWTH FACTOR 4; GELATIN; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH FACTOR; HEPARIN; LIPOSOME; MICROSPHERE; NITRIC ACID DERIVATIVE; PLACEBO; PLASMID DNA; SARPOGRELATE; SCATTER FACTOR; VASCULOTROPIN; VASCULOTROPIN 121; VASCULOTROPIN 165; VASCULOTROPIN C;

ABSENCE OF SIDE EFFECTS; ADJUVANT THERAPY; AGING; ANGINA PECTORIS; ANGIOGENESIS; ANKLE BRACHIAL INDEX; ATHEROSCLEROSIS; BIODEGRADABILITY; CARDIOVASCULAR DISEASE; CELL HOMING; CELL THERAPY; CELL TRANSPLANTATION; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CORONARY ARTERY BYPASS SURGERY; CORONARY ARTERY DISEASE; DISEASE ASSOCIATION; DISEASE SEVERITY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM COMPARISON; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG RELEASE; DRUG SAFETY; DRUG TISSUE LEVEL; EDEMA; FEASIBILITY STUDY; GENE TRANSFER; GENETIC TRANSDUCTION; HEART INFARCTION; HEART MUSCLE CELL; HEART MUSCLE ISCHEMIA; HEART MUSCLE REVASCULARIZATION; HEART TAMPONADE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; HYDROGEL; HYPOTENSION; INCIDENCE; INTERMETHOD COMPARISON; INTERMITTENT CLAUDICATION; ISCHEMIC HEART DISEASE; KIDNEY FAILURE; LIMB ISCHEMIA; LOW DRUG DOSE; MALIGNANT NEOPLASTIC DISEASE; MONONUCLEAR CELL; MONOTHERAPY; MYOBLAST; NONHUMAN; NONVIRAL GENE THERAPY; PATIENT COMPLIANCE; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PREVALENCE; RETINA NEOVASCULARIZATION; REVIEW; SINGLE DRUG DOSE; STEM CELL; STEM CELL MOBILIZATION; THROMBOCYTOPENIA; TRANSLUMINAL CORONARY ANGIOPLASTY; VIRAL GENE THERAPY;

ANGIOGENESIS INDUCING AGENTS; ANIMALS; CARDIOVASCULAR DISEASES; DELAYED-ACTION PREPARATIONS; GENE THERAPY; HUMANS; INTERCELLULAR SIGNALING PEPTIDES AND PROTEINS; MYOCARDIAL ISCHEMIA; MYOCYTES, CARDIAC; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 36649000042     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425247.4.6.635     Document Type: Review

References (49)

1. URBICH C, DIMMELER S: Endothelial progenitor cells: characterization and role in vascular biology. Circ. Res. (2004) 95(4):343-353.
2. CARMELIET P: Mechanisms of angiogenesis and arteriogenesis. Nat. Med. (2000) 6(4):389-395.
3. WAHLBERG E: Angiogenesis and arteriogenesis in limb ischemia. J. Vasc. Surg. (2003) 38(1):198-203.
4. FERRARA N, GERBER H-P, LECOUTER J: The biology of VEGF and its receptors. Nat. Med. (2003) 9(6):669-676.
5. ASAHARA T, KAWAMOTO A: Endothelial progenitor cells for postnatal vasculogenesis. Am. J. Physiol. Cell Physiol. (2004) 287(3):C572-C579.
6. ORNITZ D, ITOH N: Fibroblast growth factors. Genome Biol. (2001) 2(3):ReviewS3005.
7. FUNAKOSHI H, NAKAMURA T: Hepatocyte growth factor: from diagnosis to clinical applications. Clin. Chim. Acta (2003) 327(1-2):1-23.
8. LAHAM RJ, REZAEE M, POST M et al.: Intracoronary and intravenous administration of basic fibroblast growth factor: myocardial and tissue distribution. Drug Metab. Dispos. (1999) 27(7):821-826.
9. BAUMGARTNER I, PIECZEK A, MANOR O et al.: Constitutive expression of phVEGF165 after intramuscular gene transfer promotes collateral vessel development in patients with critical limb ischemia. Circulation (1998) 97(12):1114-1123.
10. UNGER EF, GONCALVES L, EPSTEIN SE et al.: Effects of a single intracoronary injection of basic fibroblast growth factor in stable angina pectoris. Am. J. Cardiol. (2000) 85(12):1414-1419.
11. ESKENS FALM, VERWEJ J: The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; A review. Eur. J. Cancer (2006) 42(18):3127-3139.
12. POWERS CJ, MCLESKEY SW, WELLSTEIN A: Fibroblast growth factors, their receptors and signaling. Endocr. Relat. Cancer (2000) 7(3):165-197.
13. PETER AC: Molecular targets for retinal vascular diseases. J. Cell Physiol. (2007) 210(3):575-581.
14. JAIN RK: Molecular regulation of vessel maturation. Nat. Med. (2003) 9(6):685-693.
15. GILGENKRANTZ H, DUBOC D, JUILLARD V et al.: Transient expression of genes transferred in vivo into heart using first-generation adenoviral vectors: role of the immune response. Hum. Gene Ther. (1995) 6:1265-1274.
16. GRUCHALA M, BHARDWAJ S, PAJUSOLA K et al.: Gene transfer into rabbit arteries with adeno-associated virus and adenovirus vectors. J. Gene Med. (2004) 6(5):545-554.
17. MARSHALL E; CLINICAL TRIALS: Gene therapy death prompts review of adenovirus vector. Science (1999) 286(5448):2244-2245.
18. SIMONS M, ANNEX BH, LAHAM RJ et al.: Pharmacological treatment of coronary artery disease with recombinant fibroblast growth factor-2: double-blind, randomized, controlled clinical trial. Circulation (2002) 105(7):788-793.
19. LAHAM RJ, REZAEE M, POST M et al.: Intracoronary and intravenous administration of basic fibroblast growth factor: myocardial and tissue distribution. Drug Metab. Dispos. (1999) 27(7):821-826.
20. HENRY TD, ANNEX BH, MCKENDALL GR et al.: The VIVA trial: vascular endothelial growth factor in ischemia for vascular angiogenesis. Circulation (2003) 107(10):1359-1365.
21. GRINES CL, WATKINS MW, HELMER G et al.: Angiogenic gene therapy (AGENT) trial in patients with stable angina pectoris. Circulation (2002) 105(11):1291-1297.
22. GRINES CL, WATKINS MW, MAHMARIAN JJ et al.: A randomized, double-blind, placebo-controlled trial of Ad5FGF-4 gene therapy and its effect on myocardial perfusion in patients with stable angina. J. Am. Coll. Cardiol. (2003) 42(8):1339-1347.
23. BARBEAU G, BEATT K, BETRIU A et al.: Adenoviral fibroblast growth factor-4 gene therapy in patients with stable angina. 12-month results of a double blind randomized multicenter trial. J. Am. Coll. Cardiol. (2006) 47(Suppl. 1):A305.
24. HENRY TD, GRINES CL, WATKINS MW et al.: Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J. Am. Coll. Cardiol. (2007) 50(11):1038-1046.
25. HEDMAN M, HARTIKAINEN J, SYVANNE M et al.: Safety and feasibility of catheter-based local intracoronary vascular endothelial growth factor gene transfer in the prevention of postangioplasty and in-stent restenosis and in the treatment of chronic myocardial ischemia: Phase II results of the Kuopio angiogenesis trial (KAT). Circulation (2003) 107(21):2677-2683.
26. KASTRUP J, JORGENSEN E, RUCK A et al.: Direct intramyocardial plasmid vascular endothelial growth factor-A165 gene therapy in patients with stable severe angina pectoris: a randomized double-blind placebo-controlled study: the Euroinject one trial. J. Am. Coll. Cardiol. (2005) 45(7):982-988.
27. STEWART DJ, HILTON JD, ARNOLD JMO et al.: Angiogenic gene therapy in patients with nonrevascularizable ischemic heart disease: a Phase II randomized, controlled trial of AdVEGF121 (AdVEGF121) versus maximum medical treatment. Gene Ther. (2006) 13(21):1503-1511.
28. RIPA RS, WANG Y, JORGENSEN E, JOHNSEN HE, HESSE B, KASTRUP J: Intramyocardial injection of vascular endothelial growth factor-A165 plasmid followed by granulocyte-colony stimulating factor to induce angiogenesis in patients with severe chronic ischaemic heart disease. Eur. Heart J. (2006) 27(15):1785-1792.
29. LEDERMAN RJ, MENDELSOHN FO, ANDERSON RD et al.: Therapeutic angiogenesis with recombinant fibroblast growth factor-2 for intermittent claudication (the TRAFFIC study): a randomised trial. Lancet (2002) 359(9323):2053-2058.
30. MAKINEN K, MANNINEN H, HEDMAN M et al.: Increased vascularity detected by digital subtraction angiography after VEGF gene transfer to human lower limb artery: a randomized, placebo-controlled, double-blinded Phase II study. Mol. Ther. (2002) 6(1):127-133.
31. KUSUMANTO YH, VAN WEEL V, MULDER NH et al.: Treatment with intramuscular vascular endothelial growth factor gene compared with placebo for patients with diabetes mellitus and critical limb ischemia: a double-blind randomized trial. Hum. Gene Ther. (2006) 17(6):683-691.
32. RAJAGOPALAN S, MOHLER ER III, LEDERMAN RJ et al.: Regional angiogenesis with vascular endothelial growth factor in peripheral arterial disease: a Phase II randomized, double-blind, controlled study of adenoviral delivery of vascular endothelial growth factor 121 in patients with disabling intermittent claudication. Circulation (2003) 108(16):1933-1938.
33. POWELL RJ, DORMANDY J, SIMONS M, MORISHITA R, ANNEX BH: Therapeutic angiogenesis for critical limb ischemia: design of the hepatocyte growth factor therapeutic angiogenesis clinical trial. Vasc. Med. (2004) 9(3):193-198.
34. TABATA Y, IKADA Y: Protein release from gelatin matrices. Adv. Drug Deliv. Rev. (1998) 31(3):287-301.
35. TABATA Y: Tissue regeneration based on growth factor release. Tissue Eng. (2003) 9(Suppl. 1):S5-S15.
36. EDELMAN ER, MATHIOWITZ E, LANGER R, KLAGSBRUN M: Controlled and modulated release of basic fibroblast growth factor. Biomaterials (1991) 12(7):619-626.
37. LAHAM RJ, SELLKE FW, EDELMAN ER et al.: Local perivascular delivery of basic fibroblast growth factor in patients undergoing coronary bypass surgery: results of a Phase I randomized, double-blind, placebo-controlled trial. Circulation (1999) 100(18):1865-1871.
38. SAKAKIBARA Y, TAMBARA K, SAKAGUCHI G et al.: Toward surgical angiogenesis using slow-released basic fibroblast growth factor. Eur. J. Cardiothorac. Surg. (2003) 24(1):105-111; discussion 12.
39. O'SHAUGHNESSY L: Surgical treatment of cardiac ischemia. Lancet (1937) 232:185-194.
40. UEYAMA K, BING G,TABATA Y et al.: Development of biologic coronary artery bypass grafting in a rabbit model: revival of a classic concept with modern biotechnology. J. Thorac. Cardiovasc. Surg. (2004) 127(6):1608-1615.
41. TAKABA K, JIANG C, NEMOTO S et al.: A combination of omental flap and growth factor therapy induces arteriogenesis and increases myocardial perfusion in chronic myocardial ischemia: evolving concept of biologic coronary artery bypass grafting. J. Thorac. Cardiovasc. Surg. (2006) 132(4):891-899.
42. SAKAKIBARA Y, NISHIMURA K, TAMBARA K et al.: Prevascularization with gelatin microspheres containing basic fibroblast growth factor enhances the benefits of cardiomyocyte transplantation. J. Thorac. Cardiovasc. Surg. (2002) 124(1):50-56.
43. TAMBARA K, PREMARATNE GU, SAKAGUCHI G et al.: Administration of control-released hepatocyte growth factor enhances the efficacy of skeletal myoblast transplantation in rat infarcted hearts by greatly increasing both quantity and quality of the graft. Circulation (2005) 112(9 Suppl.):I129-I134.
44. DOI K, IKEDA T, MARUI A et al.: Enhanced angiogenesis by gelatin hydrogels incorporating basic fibroblast growth factor in rabbit model of hind limb ischemia. Heart Vessels (2007) 22(2):104-108.
45. MARUI A, KANEMATSU A, YAMAHARA K et al.: Simultaneous application of basic fibroblast growth factor and hepatocyte growth factor to enhance the blood vessels formation. J. Vasc. Surg. (2005) 41(1):82-90.
46. HIROSE K, FUJITA M, MARUI A et al.: Combined treatment of sustained-release basic fibroblast growth factor and sarpogrelate enhances collateral blood flow effectively in rabbit hindlimb ischemia. Circ. J. (2006) 70(9):1190-1194.
47. MARUI A, TABATA Y, KOJIMA S et al.: A novel approach to therapeutic angiogenesis for patients with critical limb ischemia by sustained release of basic fibroblast growth factor using biodegradable gelatin hydrogel: an initial report of the Phase I - IIa study. Circ. J. (2007) 71(8):1181-1186.
48. RIVARD A, FABRE J-E, SILVER M et al.: Age-dependent impairment of angiogenesis. Circulation (1999) 99(1):111-120.
49. VAN BELLE E, RIVARD A, CHEN D et al.: Hypercholesterolemia attenuates angiogenesis but does not preclude augmentation by angiogenic cytokines. Circulation (1997) 96(8):2667-2674.