AGTP: regeneration with heart adipose tissue

Vascularised pericardial-derived adipose flap; Preclinical studies

In the ICREC group we envisioned a novel intervention , based on the transposition of a pericardial adipose-derived vascular flap over zones of acute or chronic myocardial infarction in a porcine model. After a lateral thoracotomy, the pericardial adipose tissue was detached maintaining its vascularization to create the vascular adipose flap. Then, the pericardium was partially excised to expose the outer surface of the cardiac chambers and pericardial adipose flap was gently positioned to ensure full coverage of the ischemic zone. As a result, in acute myocardial infarction a 19% improvement in ejection fraction was detected in treated animals and end-systolic and end-diastolic volumes were also diminished in comparison to controls. Moreover, both in acute and chronic myocardial infarction, has been demonstrated the presence of vascular connections between the adipose flap and the adjacent myocardium, a significant reduction of myocardial scarring in both models and decreased cardiomyocyte apoptosis in the acute setting.

1.Gálvez-Montón C, Prat-Vidal C, Roura S, Farré J, Soler-Botija C, Llucià-Valldeperas A, Díaz-Güemes I, Sánchez-Margallo FM, Arís A, Bayes-Genis A. Transposition of a pericardial-derived vascular adipose flap for myocardial salvage after infarct. Cardiovasc Res. 2011 Sep 1;91(4):659-67.

2.Gálvez-Montón C, Prat-Vidal C, Roura S, Soler-Botija C, Llucià-Valldeperas A, Díaz-Güemes I, Sánchez-Margallo FM, Bayes-Genis A. Post-infarction scar coverage using a pericardial-derived vascular adipose flap. Pre-clinical results. Int J Cardiol. 2013 Jun 20;166(2):469-74.

3.Gálvez-Montón C, Gastelurrutia P, Diaz-Güemes I, Sanchez-Margallo FM, Bayes-Genis A. Minimally Invasive Adipose Graft Transposition Procedure. J Cardiovasc Transl Res. 2017 Feb;10(1):66-68.

Collaborating center: Centro de Cirugía de Mínima Invasión Jesús Usón (CCMI); Dr. Francisco Manuel Sánchez-Margallo.

AGTP I: Phase I clinical trial, AdiFlap study

As a first step to the translation of the AGTP, a safety clinical trial was carried out with 10 patients at the Germans Trias i Pujol University Hospital, the AGTP I trial, also named adiFlap trial.
In the following interview, Dr. Bayés talks about it (interview in Catalan):

The results indicated that AGTP is safe and may be efficacious in selected patients.

Bayes-Genis A, Gastelurrutia P, Cámara ML, Teis A, Lupón J, Llibre C, Zamora E, Alomar , Ruyra X, Roura S, Revilla A, San Román JA, Gálvez-Montón C. First-in-man safety and efficaty of the Adipose Graft Transposition Procedure (AGTP) in patients with a myocardial scar. EBioMedicine. 2016;7:248-54.

Next step, was to perform a phase II efficay trial,

AGTP II: Phase II clinical trial, efficacy multicentric study

Currently, an efficacy study is being developed in collaboraion with different national and international centers:

Gastelurrutia P, Gálvez-Montón C, Cámara ML, Bustamante-Munguira J, García-Pavia P, Avanzas P, Alberto San Román J, Pascual-Figal D, Teresa E, Crespo-Leiro MG, Manito N, Núñez J, Fernández-Avilés F, Caballero Á, Teis A, Lupón J, Brugada R, Martín C, Silva J, Revilla-Orodea A, Cánovas SJ, Melero JM, Cuenca-Castillo JJ, Gonzalez-Pinto A, Bayes-Genis A. Rationale and design of a multicentre, prospective, randomised, controlled clinical trial to evaluate the efficacy of the adipose graft transposition procedure in patients with a myocardial scar: the AGTP II trial. BMJ Open. 2017;7(8):e017187.

This project has received funding from competitive funds of the Instituto de Salud Carlos III (PI17/01487 and PIC18/00014).