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The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction.

Publication ,  Journal Article
Henry, TD; Pepine, CJ; Lambert, CR; Traverse, JH; Schatz, R; Costa, M; Povsic, TJ; David Anderson, R; Willerson, JT; Kesten, S; Perin, EC
Published in: Catheter Cardiovasc Interv
February 1, 2017

OBJECTIVE: To assess safety and feasibility of autologous adipose-derived regenerative cells (ADRCs), for treatment of chronic ischemic cardiomyopathy patients. BACKGROUND: Preclinical and early clinical trials suggest ADRCs have excellent potential for ischemic conditions. METHODS: The Athena program consisted of two parallel, prospective, randomized (2:1, active: placebo), double-blind trials assessing intramyocardial (IM) ADRC delivery [40-million, n = 28 (ATHENA) and 80-million (ATHENA II) cells, n = 3]). Patients with an EF ≥20% but ≤45%, multivessel coronary artery disease (CAD) not amenable to revascularization, inducible ischemia, and symptoms of either angina (CCS II-IV) or heart failure (NYHA Class II-III) on maximal medical therapy were enrolled. All patients underwent fat harvest procedure (≤450 mL adipose), on-site cell processing (Celution® System, Cytori Therapeutics), electromechanical mapping, and IM delivery of ADRCs or placebo. RESULTS: Enrollment was terminated prematurely due to non-ADRC-related adverse events and subsequent prolonged enrollment time. Thirty-one patients (17-ADRCs, 14-placebo) mean age 65 ± 8 years, baseline LVEF(%) 31.1 ± 8.7 (ADRC), 31.8 ± 7.7 (placebo) were enrolled. Change in V02 max favored ADRCs (+45.4 ± 222 vs. -9.5 ± 137 mL/min) but there was no difference in left ventricular function or volumes. At 12-months, heart failure hospitalizations occurred in 2/17 (11.7%) [ADRC] and 3/14 (21.4%) [placebo]. Differences in NYHA and CCS classes favored ADRCs at 12-months with significant improvement in MLHFQ (-21.6 + 13.9 vs. -5.5 + 23.8, P = 0.038). CONCLUSIONS: A small volume fat harvest, automated local processing, and IM delivery of autologous ADRCs is feasible with suggestion of benefit in "no option" CAD patients. Although the sample size is limited, the findings support feasibility and scalability for treatment of ischemic cardiomyopathy with ADRCs. © 2016 Wiley Periodicals, Inc.

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Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

February 1, 2017

Volume

89

Issue

2

Start / End Page

169 / 177

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Ventricular Dysfunction, Left
  • United States
  • Treatment Outcome
  • Transplantation, Autologous
  • Time Factors
  • Stroke Volume
  • Stem Cell Transplantation
  • Regeneration
  • Recovery of Function
 

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Henry, T. D., Pepine, C. J., Lambert, C. R., Traverse, J. H., Schatz, R., Costa, M., … Perin, E. C. (2017). The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction. Catheter Cardiovasc Interv, 89(2), 169–177. https://doi.org/10.1002/ccd.26601
Henry, Timothy D., Carl J. Pepine, Charles R. Lambert, Jay H. Traverse, Richard Schatz, Marco Costa, Thomas J. Povsic, et al. “The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction.Catheter Cardiovasc Interv 89, no. 2 (February 1, 2017): 169–77. https://doi.org/10.1002/ccd.26601.
Henry TD, Pepine CJ, Lambert CR, Traverse JH, Schatz R, Costa M, et al. The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction. Catheter Cardiovasc Interv. 2017 Feb 1;89(2):169–77.
Henry, Timothy D., et al. “The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction.Catheter Cardiovasc Interv, vol. 89, no. 2, Feb. 2017, pp. 169–77. Pubmed, doi:10.1002/ccd.26601.
Henry TD, Pepine CJ, Lambert CR, Traverse JH, Schatz R, Costa M, Povsic TJ, David Anderson R, Willerson JT, Kesten S, Perin EC. The Athena trials: Autologous adipose-derived regenerative cells for refractory chronic myocardial ischemia with left ventricular dysfunction. Catheter Cardiovasc Interv. 2017 Feb 1;89(2):169–177.
Journal cover image

Published In

Catheter Cardiovasc Interv

DOI

EISSN

1522-726X

Publication Date

February 1, 2017

Volume

89

Issue

2

Start / End Page

169 / 177

Location

United States

Related Subject Headings

  • Ventricular Function, Left
  • Ventricular Dysfunction, Left
  • United States
  • Treatment Outcome
  • Transplantation, Autologous
  • Time Factors
  • Stroke Volume
  • Stem Cell Transplantation
  • Regeneration
  • Recovery of Function