Guided Tissue Regeneration in Heart Valve Replacement: from Preclinical Research to First-in-human Trials

Overview

Journal Biomed Res Int

Publisher Wiley

Specialties Biomedical Engineering
Biotechnology
General Medicine

Date 2015 Oct 24

PMID 26495295

Citations 16

Authors

L Iop

G Gerosa

Affiliations

Soon will be listed here.

Abstract

Heart valve tissue-guided regeneration aims to offer a functional and viable alternative to current prosthetic replacements. Not requiring previous cell seeding and conditioning in bioreactors, such exceptional tissue engineering approach is a very fascinating translational regenerative strategy. After in vivo implantation, decellularized heart valve scaffolds drive their same repopulation by recipient's cells for a prospective autologous-like tissue reconstruction, remodeling, and adaptation to the somatic growth of the patient. With such a viability, tissue-guided regenerated conduits can be delivered as off-the-shelf biodevices and possess all the potentialities for a long-lasting resolution of the dramatic inconvenience of heart valve diseases, both in children and in the elderly. A review on preclinical and clinical investigations of this therapeutic concept is provided with evaluation of the issues still to be well deliberated for an effective and safe in-human application.

Citing Articles

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References

Naso F, Iop L, Spina M, Gerosa G . Are FDA and CE sacrificing safety for a faster commercialization of xenogeneic tissue devices? Unavoidable need for legislation in decellularized tissue manufacturing. Tissue Antigens. 2014; 83(3):193-4. DOI: 10.1111/tan.12275. View

Thubrikar M, Bosher L, Harry R, Nolan S . Mechanism of opening of the natural aortic valve in relation to the design of trileaflet prostheses. Surg Forum. 1977; 28:264-6. View

Dohmen P, Konertz W . Tissue-engineered heart valve scaffolds. Ann Thorac Cardiovasc Surg. 2010; 15(6):362-7. View

Goncalves A, Griffiths L, Anthony R, Orton E . Decellularization of bovine pericardium for tissue-engineering by targeted removal of xenoantigens. J Heart Valve Dis. 2005; 14(2):212-7. View

BODNAR E, Olsen E, FLORIO R, Dobrin J . Damage of porcine aortic valve tissue caused by the surfactant sodiumdodecylsulphate. Thorac Cardiovasc Surg. 1986; 34(2):82-5. DOI: 10.1055/s-2007-1020381. View

Kasimir M, Rieder E, Seebacher G, Wolner E, Weigel G, Simon P . Presence and elimination of the xenoantigen gal (alpha1, 3) gal in tissue-engineered heart valves. Tissue Eng. 2005; 11(7-8):1274-80. DOI: 10.1089/ten.2005.11.1274. View

Jeong S, Yoon E, Lim H, Sung S, Kim Y . The effect of space fillers in the cross-linking processes of bioprosthesis. Biores Open Access. 2013; 2(2):98-106. PMC: 3620541. DOI: 10.1089/biores.2012.0289. View

Lupinetti F, Tsai T, Kneebone J, Bove E . Effect of cryopreservation on the presence of endothelial cells on human valve allografts. J Thorac Cardiovasc Surg. 1993; 106(5):912-7. View

Ross D . Homograft replacement of the aortic valve. Lancet. 1962; 2(7254):487. DOI: 10.1016/s0140-6736(62)90345-8. View

10.

OBrien M, Goldstein S, Walsh S, Black K, Elkins R, Clarke D . The SynerGraft valve: a new acellular (nonglutaraldehyde-fixed) tissue heart valve for autologous recellularization first experimental studies before clinical implantation. Semin Thorac Cardiovasc Surg. 2000; 11(4 Suppl 1):194-200. View

11.

Lim H, Kim G, Jeong S, Kim Y . Development of a next-generation tissue valve using a glutaraldehyde-fixed porcine aortic valve treated with decellularization, α-galactosidase, space filler, organic solvent and detoxification. Eur J Cardiothorac Surg. 2014; 48(1):104-13. DOI: 10.1093/ejcts/ezu385. View

12.

Langer R, Vacanti J . Tissue engineering. Science. 1993; 260(5110):920-6. DOI: 10.1126/science.8493529. View

13.

Galili U, Mandrell R, Hamadeh R, SHOHET S, Griffiss J . Interaction between human natural anti-alpha-galactosyl immunoglobulin G and bacteria of the human flora. Infect Immun. 1988; 56(7):1730-7. PMC: 259469. DOI: 10.1128/iai.56.7.1730-1737.1988. View

14.

Simon P, Kasimir M, Seebacher G, Weigel G, Ullrich R, Salzer-Muhar U . Early failure of the tissue engineered porcine heart valve SYNERGRAFT in pediatric patients. Eur J Cardiothorac Surg. 2003; 23(6):1002-6; discussion 1006. DOI: 10.1016/s1010-7940(03)00094-0. View

15.

Perri G, Polito A, Esposito C, Albanese S, Francalanci P, Pongiglione G . Early and late failure of tissue-engineered pulmonary valve conduits used for right ventricular outflow tract reconstruction in patients with congenital heart disease. Eur J Cardiothorac Surg. 2012; 41(6):1320-5. DOI: 10.1093/ejcts/ezr221. View

16.

HARKEN D . Heart valves: ten commandments and still counting. Ann Thorac Surg. 1989; 48(3 Suppl):S18-9. DOI: 10.1016/0003-4975(89)90623-1. View

17.

Galili U . Acceleration of wound healing by α-gal nanoparticles interacting with the natural anti-Gal antibody. J Immunol Res. 2015; 2015:589648. PMC: 4397477. DOI: 10.1155/2015/589648. View

18.

Helenius A, Simons K . Solubilization of membranes by detergents. Biochim Biophys Acta. 1975; 415(1):29-79. DOI: 10.1016/0304-4157(75)90016-7. View

19.

Bloch O, Erdbrugger W, Volker W, Schenk A, Posner S, Konertz W . Extracellular matrix in deoxycholic acid decellularized aortic heart valves. Med Sci Monit. 2012; 18(12):BR487-92. PMC: 3560792. DOI: 10.12659/msm.883618. View

20.

Zhou J, Fritze O, Schleicher M, Wendel H, Schenke-Layland K, Harasztosi C . Impact of heart valve decellularization on 3-D ultrastructure, immunogenicity and thrombogenicity. Biomaterials. 2010; 31(9):2549-54. DOI: 10.1016/j.biomaterials.2009.11.088. View