Sistemic announces world-first with publication on the potential for patient stratification using a cell-based therapy for refractory rheumatoid arthritis

Release Date: January 9, 2017

Sistemic Ltd. announced today the publication of its ground-breaking research, undertaken together with TiGenix, identifying a set of circulating miRNA biomarkers which could potentially be used, if further clinically validated, to stratify refractory rheumatoid arthritis patients, prior to treatment, into responders and non-responders to an allogenic cell-based therapy:

Identification of potential plasma microRNA stratification biomarkers for response to allogeneic adipose-derived mesenchymal stem cells in rheumatoid arthritis

David J Mallinson, Donald R Dunbar, Susan Ridha, Elizabeth R Sutton, Olga De la Rosa, Wilfried Dalemans, Eleuterio Lombardo

STEM CELLS Translational Medicine 2017 (Full pdf)

For conventional therapies, the ability to stratify patients that will respond to specific therapies has been transformational in a number of disease areas, particularly oncology. The cell therapy sector offers great hope in the treatment of a wide range of diseases and also some diseases which have, until now, been beyond conventional treatments. Nevertheless, the ability to pre-select patients who will respond to cell-based therapies is likely be crucial to the success of these innovative therapeutic modalities. This publication is the first to announce the possibility to similarly stratify patients and give a pre-assessment of the likely outcome to a cell therapy treatment.

The work was supported by REGENER-AR, an EU FP7 grant for research, technological development and demonstration (Grant number 279174) and is derived from the TiGenix phase Ib/IIa clinical trial on the use of allogeneic adipose-derived mesenchymal stem cells in refractory rheumatoid arthritis [Cx611] (Alvaro-Gracia et al. Ann Rheum Dis. 2017).

Jim Reid, Chairman and CEO of Sistemic stated, “This has the potential to be a real breakthrough in clinical assessment for cellular therapies. The ability to be able to pre-assess patients and, using a circulating set of biomarkers,allow them to be stratified will bring great benefit to the cell therapy industry and hopefully, in time, also to healthcare systems worldwide as they start to introduce these exciting and revolutionary therapies which can treat many diseases which, at the moment, are beyond treatment.”

Dr David Mallinson, Vice President of Scientific Operations stated, “We are very excited about the outcome of this study identifying a set of circulating miRNAs associated with refractory rheumatoid patient response to a cell-based therapy. Although further validation of these candidate stratification biomarkers is required, this is to our knowledge, the first report identifying stratification biomarkers for response to a cell-based therapy, and as such, is an important first step in this area for these innovative therapeutic modalities.”


Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell and Gene Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. Furthermore, cell products in the later stages of clinical development benefit from SistemQC™ miRNA-based profiling approach in facilitating patient stratification and monitoring the response to the treatment. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™. Sistemic has a worldwide customer base and a strong intellectual property portfolio.

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