Cytori Therapeutics is to use Sistemic’s SistemQC™ technology in a cardiac cell therapy clinical trial to facilitate molecular characterization of adipose-derived stem and regenerative cells (ADRCs). The SistemQC is a quality control (QC) and characterization tool the uses miRNA-based fingerprinting to monitor cells and stem cells for identity, potency, purity, characterization, differentiation stage markers, benchmarking cell models, cell line drift, and QC of batch-to-batch consistency.
“SistemQC will be incorporated into our clinical development to understand which cell types within our Celution® system’s autologous heterogeneous population of ADRCs are the greatest contributors to efficacy,” states Douglas Arm Ph.D., svp of operations at Cytori. “With SIstemic’s novel technology we can strengthen the mechanistic understanding of our cell output and at the same time support the design of next-generation cell therapies.”
ADRCs are a heterogeneous population of adult stem cells, endothelial progenitor cells, leukocytes, endothelial cells, and vascular smooth muscle cells. The firm claims that while stem and progenitor cells usually make up less than 5% of all ADRCs, this is still 2,500-fold more than the proportion of such cells in tissues such as bone marrow. The abundance of ADRCs in adipose tissue and the ability to easily collect large amounts of adipose tissue via liposuction thus eliminates the need for tissue culturing.
Cytori’s Celution system is being developed to separate out ADRCs (stromal vascular fraction cells) from liposuctioned tissue to provide a source of clinical-grade regenerative cells for potential applications in treatment of a range of conditions, including cardiovascular disease, soft tissue defects, and wounds. The process is intended to take place primarily at the bedside so that the cells can be redelivered during the same surgical procedure or preserved for future use.
Cytori is initially focusing on application of the platform for heart disease and reconstructive surger. To this end the firm is sponsoring three European clinical trials evaluating the use of ADRCs to treat acute myocardial infarction and chronic myocardial ischemia and a European trial in patients requiring breast reconstruction after lumpectomy for breast cancer.