Cytori Therapeutics announced the presentation of data demonstrating a statistically significant reduction in ventricular tachyarrhythmias following Adipose-Derived Regenerative Cell (ADRC) Therapy in patients with acute heart attack. The findings were presented at the 6th International Conference on Cell Therapy for Cardiovascular Disease by co-Principal Investigator on the Apollo study, Henricus J. Duckers, MD, PhD, Interventional Cardiologist, Head of Molecular Cardiology, Thoraxcentre, Erasmus University Hospital, Rotterdam, The Netherlands.
In Dr Duckers' presentation, ADRC therapy was associated with a significantly lower incidence of ventricular tachyarrhythmias. A total of three episodes of ventricular tachyarrhythmia were reported in the treated group as compared to 10 in the control group (p=0.018). On a per patient basis, the treated group experienced a mean of 0.3 episodes of ventricular tachyarrhythmias as compared to 2.5 in the control group (p=0.048).
The analysis of Holter recordings also indicated lower incidence of Premature Ventricular Contractions (PVC, a single abnormal beat) in patients treated with ADRCs. In ADRC-treated patients, 5 PVCs per patient, per day, were reported whereas in placebo-treated patients, the number of PVCs reported per patient, per day, was 72 (p=0.014).
Forty-eight hour Holter recordings were obtained weekly for the first month after discharge followed by 24-hour recordings at 2, 3, 4 and 6 months post-procedure. All Holter recordings were assessed by an independent, blinded Holter core laboratory. Post-hoc data analyses of Holter data were conducted independently by Thoraxcentre.
“Although not the primary study endpoint, the observed reduction in arrhythmias supports the safety of ADRCs in the treatment of patients with an acute heart attack,” said Dr Duckers. “Furthermore, the data presented are consistent with previously reported results from Cytori's preclinical studies.”
Six month primary outcomes were reported from the Apollo study in May 2010 at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, Spain.
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution System family of medical devices and instruments are being sold into the European and Asian cosmetic, reconstructive surgery and wound markets.