BioOutsource. Leading providers of scientific contract testing services Home About us Partners News & Events Quality Knowledge Centre Contact Us Search General News & Events Blog Knowledge Centre Regulations Biosimilars Virus and Vectors Recombinant Proteins Monoclonal Antibodies ADC Regenerative Medicine REGENERATIVE MEDICINE Testing requirements for Stem Cell Products Regenerative Medicine Regenerative Medicine BioOutsource provides a complete service for the chracterisation of stem cells as defined by the European (EMA) and USA (FDA) agencies. We have been involved in testing and characterising many of the early stem cell products used in clinical trials in Europe. Assessing BioMarkers in stem cells is key to understanding many of these products and BioOutsource has a number of methods available for use. The use of Stem Cells in Regenerative medicine is the process of creating functioning cells to repair or replace tissue or organ function lost due to damage, or congenital defects. This area of medicine holds the promise of treating intractable diseases regenerating damaged tissues and organs in the body. Embryonic stem cells were once thought to be the means of delivering treatment options but the use of adult stem cells has shown promise and may alleviate some of the concerns. Moving a stem cell product from discovery to the clinic and eventually to treat a larger population of patients is clearly a priority for many small and large scale companies. All of these manufacturers are dealing with the characterization of a difficult product with sometimes very transient features. Types of Stem Cell Products Embryonic stem cells These cells as the name suggests originate from embryos and are maintained in vitro as established cell lines. Human Embryonic stem cells (HESCs) are typically pluripotent and therefore have the capacity to differentiate into every cell type found in the human body. Different stages of development of HESCs are defined by specific groups of cell surface markers (CD9, E-Cadherin, Podocalyxin, Nanog, Oct-3/4, SOX2, SSEA-1, and SSEA-4). The main reason for the sse of HESCs is that these cells can be differentiated in vitro using cytokines or other biomodulating compounds or in some cases by direct gene manipulation. One disadvantage of this type of produciton is the mixed populations of cells at different differentiation stages. Mesenchymal, stromal/stem cells A new and exciting area of stem cell research is that of Mesenchymal Stem cells (MSCs); these cells are harvested from adult bone marrow or adipose tissue, but can be harvested from other sites. MSCs can be characterised by the expression of specific cell surface markers (Bone Morphogenetic Proteins (BMPR), Endoglin, Stem Cell Factor Receptor (SCF R), and STRO-1) and their ability to further differentiate. Tissue specific stem cells Tissue specific stem cells are harvested for particular lineages already defined and have included tenocytes, myocytes and astrocytes in the past. Haematopoietic stem cells These are defined by the European Regulations (EMA) as a sub-class of tissue-specific stem cells. These are again from adult (non-embryonic) cells and will give rise to differentiated cells of all haematopoietic lineages; these cells have been evaluated for use following intensive chemotherapy. Induced pluripotent stem cells This cell type differs from the others in that these cells are reprogrammed, such as inhibitor of TGF-betaRI, ALK4 and/or ALK7, from somatic adult cells to share many features of hESCs. This area of research is perhaps the most exciting field of stem cell research. Their differentiation capacity however is poorly understood at present and is dependant on a number of factors. Facility Privacy policy Legal Site Map BioOutsource Limited. 1 Technology Terrace, Todd Campus, West of Scotland Science Park, Glasgow, G20 0XA. Telephone +44 (0)141 946 4222 Web design by Beyond.