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<p>Percutaneous autologous expanded CD34⁺ cell therapy (ProtheraCytes<sup>®</sup>) has demonstrated feasibility, manageable safety concerns and a regenerative potential in the EXCELLENT phase I/IIb trial (NCT02669810). Objective of our study was to assess HRQoL over 6 months following ProtheraCytes<sup>®</sup> therapy in patients with recent large AMI and left ventricular (LV) dysfunction. EXCELLENT was a multicenter, randomized, open-label, controlled phase I/IIb trial enrolling 77 AMI patients. Participants were randomized 3:1 to standard-of-care (SoC) plus transendocardial ProtheraCytes<sup>®</sup> injections or SoC alone. The per-protocol population included 49 subjects. Of those, 31 treated and 12 control patients were analyzable with complete baseline and follow-up 36-Item Short Form Survey (SF-36) data. HRQoL domains and composite scores were analyzed using repeated-measures ANCOVA adjusted for baseline values. At baseline, HRQoL was markedly impaired, consistent with severe LV dysfunction (mean physical functioning score at 63.3, LVEF 35.2%, elevated NT-proBNP). At 6 months, the treated group showed significant and sustained meaningful improvements in physical functioning (+ 16.6 PF, <i>p</i> = 0.0002), vitality (+ 12.7 VT, <i>p</i> = 0.0072), social functioning (+ 17.9 SF, <i>p</i> = 0.0059), and bodily pain (+ 17.0 BP, <i>p</i> = 0.0031). Between months 3 and 6, most HRQoL domains declined in controls but remained stable or improved in treated patients. In conclusion, ProtheraCytes<sup>®</sup> therapy was associated with significant HRQoL gains sustained over 6 months, alongside biological improvements. These findings support further evaluation of expanded CD34⁺ cell therapy to address the unmet need for durable functional recovery post-AMI.</p> Graphical Abstract <p></p>

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TransEndocardial Injection of Autologous Expanded CD34+ Stem Cells (ProtheraCytes®) after myocardial infarction: Impact on Patients’ Quality of Life

  • 期刊论文

  • 发表日期：

    2026年3月3日

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  • Jérôme Roncalli,
  • François Roubille,
  • Philippe Henon,
  • Pierre-Yves Marie,
  • Gilles Montalescot,
  • Deepak L. Bhatt,
  • Guillaume Trebuchet,
  • Matthieu de Kalbermatten,
  • Ibon Garitaonandia,
  • David M. Smadja

摘要

Percutaneous autologous expanded CD34⁺ cell therapy (ProtheraCytes®) has demonstrated feasibility, manageable safety concerns and a regenerative potential in the EXCELLENT phase I/IIb trial (NCT02669810). Objective of our study was to assess HRQoL over 6 months following ProtheraCytes® therapy in patients with recent large AMI and left ventricular (LV) dysfunction. EXCELLENT was a multicenter, randomized, open-label, controlled phase I/IIb trial enrolling 77 AMI patients. Participants were randomized 3:1 to standard-of-care (SoC) plus transendocardial ProtheraCytes® injections or SoC alone. The per-protocol population included 49 subjects. Of those, 31 treated and 12 control patients were analyzable with complete baseline and follow-up 36-Item Short Form Survey (SF-36) data. HRQoL domains and composite scores were analyzed using repeated-measures ANCOVA adjusted for baseline values. At baseline, HRQoL was markedly impaired, consistent with severe LV dysfunction (mean physical functioning score at 63.3, LVEF 35.2%, elevated NT-proBNP). At 6 months, the treated group showed significant and sustained meaningful improvements in physical functioning (+ 16.6 PF, p = 0.0002), vitality (+ 12.7 VT, p = 0.0072), social functioning (+ 17.9 SF, p = 0.0059), and bodily pain (+ 17.0 BP, p = 0.0031). Between months 3 and 6, most HRQoL domains declined in controls but remained stable or improved in treated patients. In conclusion, ProtheraCytes® therapy was associated with significant HRQoL gains sustained over 6 months, alongside biological improvements. These findings support further evaluation of expanded CD34⁺ cell therapy to address the unmet need for durable functional recovery post-AMI.

Graphical Abstract