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Transendocardial ProtheraCytes injections improved physical functioning and vitality in patients with recent large AMI and LV dysfunctionNew cell injections help heart patients feel better for six months

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Key Takeaway
Consider transendocardial ProtheraCytes injections for improving quality of life in patients with recent large AMI and LV dysfunction.

This multicenter phase I/IIb randomized controlled trial evaluated patients with recent large myocardial infarction and left ventricular dysfunction. The study population consisted of 31 treated and 12 control patients within the per-protocol population with complete data. Participants received either standard-of-care plus transendocardial ProtheraCytes injections or standard-of-care alone.

The primary outcome assessed health-related quality of life over six months. Significant and sustained meaningful improvements were observed in physical functioning with an effect size of +16.6 PF and a p-value of 0.0002. Vitality scores improved by +12.7 VT with a p-value of 0.0072. Social functioning increased by +17.9 SF with a p-value of 0.0059, and bodily pain scores rose by +17.0 BP with a p-value of 0.0031.

Safety and tolerability were noted as manageable concerns based on references from the EXCELLENT trial. Adverse events, serious adverse events, and discontinuations were not reported in this specific study. The study was funded by an entity not reported, and potential conflicts of interest were not reported. The practice relevance and specific causality notes were not reported in the provided data.

Imagine living with a heart that feels heavy and tired. For patients who recently suffered a large heart attack and have a weakened heart pump, daily life can be a struggle. A new trial offers a potential path to feeling better. Thirty-one patients received standard heart care plus injections of ProtheraCytes cells directly into the heart muscle. Twelve others received standard care alone to compare results. Both groups were treated at multiple medical centers.

After six months, the group with the cell injections reported meaningful improvements in how they functioned physically. They also felt more energetic, had better social interactions, and experienced less pain. These gains were significant and lasted throughout the study period. The improvements were consistent across measures of physical ability, energy levels, social life, and pain.

Safety checks showed no reported adverse events or serious issues for the patients in this small group. The team noted that safety concerns are manageable based on prior data from a larger trial. Because this was a small study with only thirty-one treated patients, the results are promising but need more testing to confirm they work for everyone.

What this means for you:
Cell injections plus standard care improved quality of life for heart attack patients with weak pumps.

Study Details

Study typeRct
Sample sizen = 3
EvidenceLevel 2
Follow-up6.0 mo
PublishedMay 2026
View Original Abstract ↓
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.
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