CD34+ stem cells promote reverse cardiac remodelling after acute MI

In patients with left ventricular (LV) dysfunction after an acute myocardial infarction (MI), transendocardial injection of autologous expanded CD34+ stem cells (ProtheraCytes®) was feasible. The 6-month results of the phase 1/2b EXCELLENT study suggest that this therapy may promote reverse cardiac remodelling.

Prof. Faiez Zannad (University of Lorraine, France) explained that ProtheraCytes comprises a reproducible expansion of autologous CD34+ cells through an automated process. CD34+ cells are the most efficient cells to regenerate post-ischaemic myocardial damage. CD34+ cells are harvested from a patient’s peripheral blood, expanded in culture, and re-administered to the patient. The phase 1/2b EXCELLENT study (EUDRACT 2014–001476-63) is a randomised, open-label, blinded evaluation endpoint trial across 13 French and British centres [1]. The 77 participants were randomised to standard-of-care (SOC) alone (n=16) or SOC with ProtheraCytes (n=61). All participants had persistent LV dysfunction and high troponin levels 1 week following acute MI. The primary endpoint was the incidence of major adverse cardiovascular events (MACE) after 6 months.

The evaluable population consisted of 16 patients in the SOC group and 33 in the SOC with ProtheraCytes group. Heart failure hospitalisations occurred in 5 participants in the SOC group and in 1 participant in the SOC with ProtheraCytes group. No periprocedural events occurred in the SOC group, whereas 9 were reported in the SOC with ProtheraCytes group (4 tamponades, 2 pericarditis, 2 ischaemic strokes, and 1 arrhythmia), all of whom recovered. The mean change in hypersignal extension score at 6 months in all segments was significantly larger in the SOC with ProtheraCytes group (P<0.01). Favourable changes were also seen in LV dimensions and in NT-proBNP. There were no unexpected serious adverse events related to ProtheraCytes.

ProtheraCytes may improve reverse remodelling, as suggested by a significant improvement of the viability of segments, a positive trend of improvement in LV dimensions, and a faster decrease in NT-proBNP levels. Prof. Zannad said that a larger randomised-controlled phase 3 trial will evaluate the long-term anti-remodelling effect of ProtheraCytes.

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   1. Zannad F, et al. Transendocardial injection of autologous expanded CD34+ Stem Cells (ProtheraCytes) promotes reverse cardiac remodeling in patients with left ventricular dysfunction after acute myocardial infarction. Late breaking clinical trials II, Heart Failure 2024, 11–14 May, Lisbon, Portugal.

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Posted on 16 July 202416 July 2024