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Clinical Trial
. 2016 May:7:248-54.
doi: 10.1016/j.ebiom.2016.03.027. Epub 2016 Apr 10.

First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar

Antoni Bayes-Genis  1 , Paloma Gastelurrutia  2 , Maria-Luisa Cámara  3 , Albert Teis  4 , Josep Lupón  5 , Cinta Llibre  6 , Elisabet Zamora  6 , Xavier Alomar  7 , Xavier Ruyra  3 , Santiago Roura  8 , Ana Revilla  9 , José Alberto San Román  9 , Carolina Gálvez-Montón  2
Affiliations
Clinical Trial

First-in-man Safety and Efficacy of the Adipose Graft Transposition Procedure (AGTP) in Patients With a Myocardial Scar

Antoni Bayes-Genis et al. EBioMedicine. 2016 May.

Abstract

Background: The present study evaluates the safety and efficacy of the Adipose Graft Transposition Procedure (AGTP) as a biological regenerative innovation for patients with a chronic myocardial scar.

Methods: This prospective, randomized single-center controlled study included 10 patients with established chronic transmural myocardial scars. Candidates for myocardial revascularization were randomly allocated into two treatment groups. In the control arm (n=5), the revascularizable area was treated with CABG and the non-revascularizable area was left untouched. Patients in the AGTP-treated arm (n=5) were treated with CABG and the non-revascularizable area was covered by a biological adipose graft. The primary endpoint was the appearance of adverse effects derived from the procedure including hospital admissions and death, and 24-hour Holter monitoring arrhythmias at baseline, 1week, and 3 and 12months. Secondary endpoints of efficacy were assessed by cardiac MRI.

Findings: No differences in safety were observed between groups in terms of clinical or arrhythmic events. On follow-up MRI testing, participants in the AGTP-treated arm showed a borderline smaller left ventricular end systolic volume (LVESV; p=0.09) and necrosis ratio (p=0.06) at 3months but not at 12months. The AGTP-treated patient with the largest necrotic area and most dilated chambers experienced a noted improvement in necrotic mass size (-10.8%), and ventricular volumes (LVEDV: -55.2mL and LVESV: -37.8mL at one year follow-up) after inferior AGTP.

Interpretation: Our results indicate that AGTP is safe and may be efficacious in selected patients. Further studies are needed to assess its clinical value. (ClinicalTrials.org NCT01473433, AdiFlap Trial).

Keywords: Adipose tissue; Cardiac surgery; Cardiac tissue engineering; Myocardial infarction; Regenerative medicine; Stem cell therapy.

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Figures

Fig. 1
Fig. 1
Study design. n: number of patients, CABG: coronary artery bypass graft, AGTP: Adipose Graft Transposition Procedure, MRI: magnetic resonance imaging.
Fig. 2
Fig. 2
Schematic illustration of the Adipose Graft Transposition Procedure (AGTP). Pericardial adipose tissue is dissected to create the graft (A). After partial pericardiectomy, MI is located (B) and the pericardial adipose graft is transposed onto the infarct area and glued on healthy edges (C), covering the ischemic myocardium (D). The figure was designed and hand-drawn by CG-M.
Fig. 3
Fig. 3
MRI analysis: Representative T1 short-axis delayed enhancement images rev`eal healthy (black) and infarcted myocardium (white) for AGTP-treated and control patients at baseline and 12 months. Arrowheads point out the attached adipose graft position in the treated patients. Histograms represent changes in percentage of necrotic tissue from baseline to three months in treated and control patients.
Fig. 4
Fig. 4
Selected patient case: short-axis delayed enhanced images show the healthy (black) and infarcted myocardium (white) before and after AGTP; 4-chamber view shows patient's volumes before and after AGTP. Arrows point out the attached adipose graft position in the treated patient. ECG shows a Q wave in leads III and aVF at baseline that is not present at follow-up ECGs.
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