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@ARTICLE{Jebran:277528,
      author       = {Jebran, Ahmad-Fawad and Seidler, Tim and Tiburcy, Malte and
                      Daskalaki, Maria and Kutschka, Ingo and Fujita, Buntaro and
                      Ensminger, Stephan and Bremmer, Felix and Moussavi, Amir and
                      Yang, Huaxiao and Qin, Xulei and Mißbach, Sophie and
                      Drummer, Charis and Baraki, Hassina and Boretius, Susann and
                      Hasenauer, Christopher and Nette, Tobias and Kowallick,
                      Johannes and Ritter, Christian O and Lotz, Joachim and
                      Didié, Michael and Mietsch, Mathias and Meyer, Tim and
                      Kensah, George and Krüger, Dennis and Sakib, Sadman and
                      Kaurani, Lalit and Fischer, Andre and Dressel, Ralf and
                      Rodriguez-Polo, Ignacio and Stauske, Michael and Diecke,
                      Sebastian and Maetz-Rensing, Kerstin and Gruber-Dujardin,
                      Eva and Bleyer, Martina and Petersen, Beatrix and Roos,
                      Christian and Zhang, Liye and Walter, Lutz and Kaulfuß,
                      Silke and Yigit, Gökhan and Wollnik, Bernd and Levent, Elif
                      and Roshani, Berit and Stahl-Henning, Christiane and
                      Ströbel, Philipp and Legler, Tobias and Riggert, Joachim
                      and Hellenkamp, Kristian and Voigt, Jens-Uwe and Hasenfuß,
                      Gerd and Hinkel, Rabea and Wu, Joseph C and Behr, Rüdiger
                      and Zimmermann, Wolfram-Hubertus},
      title        = {{E}ngineered heart muscle allografts for heart repair in
                      primates and humans.},
      journal      = {Nature},
      volume       = {639},
      number       = {8054},
      issn         = {0028-0836},
      address      = {London [u.a.]},
      publisher    = {Nature Publ. Group},
      reportid     = {DZNE-2025-00424},
      pages        = {503 - 511},
      year         = {2025},
      abstract     = {Cardiomyocytes can be implanted to remuscularize the
                      failing heart1-7. Challenges include sufficient
                      cardiomyocyte retention for a sustainable therapeutic impact
                      without intolerable side effects, such as arrhythmia and
                      tumour growth. We investigated the hypothesis that
                      epicardial engineered heart muscle (EHM) allografts from
                      induced pluripotent stem cell-derived cardiomyocytes and
                      stromal cells structurally and functionally remuscularize
                      the chronically failing heart without limiting side effects
                      in rhesus macaques. After confirmation of in vitro and in
                      vivo (nude rat model) equivalence of the newly developed
                      rhesus macaque EHM model with a previously established Good
                      Manufacturing Practice-compatible human EHM formulation8,
                      long-term retention (up to 6 months) and dose-dependent
                      enhancement of the target heart wall by EHM grafts
                      constructed from 40 to 200 million cardiomyocytes/stromal
                      cells were demonstrated in macaques with and without
                      myocardial infarction-induced heart failure. In the heart
                      failure model, evidence for EHM allograft-enhanced target
                      heart wall contractility and ejection fraction, which are
                      measures for local and global heart support, was obtained.
                      Histopathological and gadolinium-based perfusion magnetic
                      resonance imaging analyses confirmed cell retention and
                      functional vascularization. Arrhythmia and tumour growth
                      were not observed. The obtained feasibility, safety and
                      efficacy data provided the pivotal underpinnings for the
                      approval of a first-in-human clinical trial on
                      tissue-engineered heart repair. Our clinical data confirmed
                      remuscularization by EHM implantation in a patient with
                      advanced heart failure.},
      keywords     = {Animals / Macaca mulatta / Humans / Tissue Engineering:
                      methods / Myocytes, Cardiac: transplantation / Myocytes,
                      Cardiac: cytology / Rats / Male / Induced Pluripotent Stem
                      Cells: cytology / Induced Pluripotent Stem Cells:
                      transplantation / Heart Failure / Myocardium: cytology /
                      Myocardium: pathology / Myocardial Infarction: therapy /
                      Myocardial Infarction: surgery / Allografts / Female /
                      Disease Models, Animal / Pericardium: transplantation /
                      Pericardium: cytology / Rats, Nude / Myocardial Contraction
                      / Heart: physiology},
      cin          = {AG Fischer},
      ddc          = {500},
      cid          = {I:(DE-2719)1410002},
      pnm          = {352 - Disease Mechanisms (POF4-352)},
      pid          = {G:(DE-HGF)POF4-352},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:39880949},
      doi          = {10.1038/s41586-024-08463-0},
      url          = {https://pub.dzne.de/record/277528},
}