Objective: This preliminary clinical study assessed the potential use of Strachan-Ovokaitys Node Generator (SONG)-modulated laser-treated expanded (3-5 passages) cord blood Mesenchymal Stem Cells (MSCs) in the treatment of end-stage heart failure.

Patients and Methods: Ten patients were enrolled into the study, each with a Left Ventricular Ejection Fraction (LVEF) of ≥20% and ≤25%. Allogeneic expanded cord blood MSCs were treated with a SONG-modulated laser prior to intravenous infusion at a total dose of 100 x10⁶ MSCs per patient. All patients also received 5 minutes of SONG-modulated laser light to the anterior precordial region and 5 minutes to the left lateral chest.  The LVEF of each patient was assessed using echocardiography on Days 3, 7, 31, 62 and 93 post-treatment.

Results: All patients showed an increase in LVEF following SONG-modulated laser-treated expanded MSC treatment and remained with increased LVEF for at least 3 months. Two patients in the study subsequently died of heart failure.

Conclusions: This is the first description of the use of SONG-modulated laser-treated cord blood MSCs in the treatment of end-stage heart failure and it sets the groundwork for future double-blind randomised controlled clinical trials.