The Bedside Celution system for isolation of adipose derived regenerative cells. (2006)

Stem cell transplantation could be an attractive adjunctive therapy to the conventional primary percutaneous coronary intervention (PCI) in the treatment of acute myocardial infarction (AMI) to salvage ischaemic myocardial tissue and preserve long term myocardial function. Indeed, feasibility of myocardial salvage by endothelial progenitor cells (EPC) or pluripotent stem cells has been shown previously under various experimental and clinical conditions and appears to have entered the arena of interventional cardiology. Transplantation of autologous mesenchymal or haematopoietic stem cells and EPCs permit long term myocardial delivery of various therapeutic growth factors at the site of ischaemic insult (with angiotrophic, anti-apoptotic and chemotactic properties) or alternatively aid myocardial function by trans-differentiation into endothelial cells or cardiomyocytes. These cells assist in the generation of new vessels with an increase in myocardial perfusion and promote myocardial salvage following acute myocardial ischaemia leading to long term preservation of local and global contractile function. Several multicentre clinical trials have shown promising results of stem cell therapy in the treatment of acute and chronic myocardial infarction on global ejection fraction, as well as local myocardial contractile function and perfusion 1-4 The widespread utilisation of this novel biotechnology in coronary catheterisation laboratories is limited by the availability and costs associated with the use of a GMP-level cell processing facility for expansion of allogeneic or autologous cells to achieve a therapeutic dose. In contrast, real time isolation of cells from adipose tissue using the Celution™ system enables the introduction of cell therapy to a conventional coronary catheterisation laboratory without specific infrastructural or logistic requirements. This device can be operated by a single technician, generating autologous adipose derived regenerative cells (ADRCs) within about one hour following tissue collection. This enables application of the cell therapy directly following the primary coronary intervention after the AMI. Using the Celution™ cell separation system, adipose tissue obtained by standard, manual liposuction is processed into a single cell suspension devoid of adipocytes which contains pluripotent stem cells, EPCs and other stromal cells. Various large and small animal acute myocardial infarction (AMI) and chronic myocardial ischaemia (CMI) studies have clearly demonstrated the feasibility, safety and efficacy of intracoronary and intramyocardial transplantation of ADRC preparations. These animal studies have shown preservation of post-AMI left ventricular ejection fraction, reduction of cardiac remodeling and an increase in myocardial perfusion, without evidence of side-effects or arrhythmias. First clinical evaluations using the Celution ™ -isolated adipose derived stem cell transplantation via intracoronary and intramyocardial delivery in patients with AMI and CMI are imminent (APOLLO and PRECISE trial). Enrolment is anticipated to start as early as December 2006.