Recently, Biological Industries (BI) submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for purposes of moving its NutriStem® hPSC XF Medium toward being certified for clinical applications. The product is a defined, xeno-free (XF), serum-free (SF) medium that supports the growth and expansion of human induced pluripotent stem (iPS) and embryonic stem cells (ESCs). [Read more…]
Since the discovery of mesenchymal stem cells (MSCs) by Friedenstein and his colleagues in 1976, MSCs have become one of the fastest growing areas of stem cell research. They are more frequently cited than any other stem cell type within the scientific literature, Google Trend data shows MSC searches to be approximately twice as common as the next most common adult stem cell type, and more than 500 MSC clinical trials are now underway worldwide.
Clearly, the market for MSCs is growing and the cells are increasingly being explored for use in a diverse range of regenerative medicine applications, including cell therapy, tissue engineering, drug screening, and more.
While there has been a great deal of product innovation surrounding the MSCs, the process innovation surrounding MSCs has been limited. Product innovation is defined as the type of MSC products that have entered the marketplace, while process innovation is defined as the strategies for manufacturing these products in high-quality, reproducible conditions on an industrial scale.
To date, most of the common media for differentiating MSCs has been composed of fetal bovine serum (FBS) and xenogenic compounds. This is a major drawback for research and clinical applications, because the presence of potential contaminants limits the use of differentiated hMSCs within regenerative medicine and drug screening applications. Furthermore, the quality of MSC culture medium and differentiation media is crucial to use of the cells in therapeutic applications, because multipotent hMSCs and differentiated cell properties can be substantially affected by medium components, culture condition, and the manual used for culturing and differentiation.
Therefore, improved cell culture systems for maintaining and differentiating MSCs will play a crucial role in moving MSCs toward use in an expanding number of commercial applications.
One company pioneering the way in this area is Biological Industries (BI). With locations in the USA, Europe, China and Israel, BI has been collaborating with academic researchers and institutes to develop cell culture media, stem cell reagents, and molecular biology tools for more than 30 years. BI also offers custom media development and manufacturing services through its ISO 13485:2003 certified cGMP compliant facilities, as well as supplies products to researchers and clinicians in over 40 countries.
Utilization of MSCs within Cell Therapy, Tissue Engineering, and Drug Screening Applications
Human mesenchymal stem cells (hMSCs) are multipotent adult stem cells that can be isolated from various tissues, as well as generated in vitro from human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPS cells). hMSCs have at least trilineage differentiation potential in vitro, meaning they can be differentiated into fat, bone, or cartilage cells. This trilineage potential is part of the Minimal Experimental Criteria for MSCs that has been proposed by the International Society for Cellular Therapy (ISCT).
Importantly, differentiation of hMSCs into specific lineage provides the basis for the use of human MSC in cell therapy applications, as both undifferentiated and differentiated hMSCs can be used for in vivo implantation into damaged tissue. However, the differentiation potential of hMSCs may differ in relation to culture conditions and source tissue, and it is still unknown which source should be used for each specific disease.
To facilitate improved culture conditions for MSCs in both research and therapeutic applications, Biological Industries recently launched novel serum-free and xeno-free hMSC differentiation kits. The launch represents a major advance within the MSC sector, because it creates a reproducible, contaminant-free environment for clinical-grade culture of human MSCs.
A Novel Set of Serum-Free, Xeno-Free Differentiation Media for Adipogenesis, Osteogenesis and Chondrogenesis of Human MSCs from Various Tissue Sources
BI’s serum-free and xeno-free kits are designed to be user friendly with all necessary ingredients included, offering a complete system for multipotency evaluation of hMSCs and reliable induction of hMSCs into adipocytes, chondrocytes and osteoblasts/osteocytes.
The kits were also validated for hMSC from various tissues, including human bone marrow MSCs (BM-hMSC), adipose tissue MSCs (AT-hMSC), umbilical cord tissue MSCs (UCT-hMSC), and dental pulp tissue MSCs (DP-hMSC).
Previously, BI had released MSC NutriStem® XF Medium, a gold standard serum-free, xeno-free medium developed for the growth and expansion of human mesenchymal stem cells (hMSC) isolated from a variety of sources (also BM-hMSC, AT-hMSC, UCT-hMSC and DP-hMSC).
Importantly, BI’s novel serum-free, xeno-free media and supplements achieve defined conditions that can efficiently differentiate hMSCs from various sources into adipocytes, osteoblasts, and chondrocytes. This allows for rapid generation of differentiated hMSCs that can be used in cell therapy, tissue engineering, and drug screening applications, and more.
The three key advantages that separate BI’s serum-free, xeno-free differentiation media from other products within MSC marketplace are:
- hMSCs from various sources can be efficiently differentiated into adipocytes, osteocytes, and chondrocytes under serum-free, xeno-free culture conditions using the MSCgo™ differentiation media.
- Superior maturation of differentiated hMSCs can be achieved under serum-free, xeno-free culture using the MSCgo™ differentiation media in comparison to competitor media.
- Rapid osteogenic maturation with intensive mineralization can be achieved using the MSCgo™ Rapid Osteogenic.
As evidence of these statements, molecular characterization and functional assays were used to evaluate both the quality and purity of the differentiated cells (see Figure 1 below). Specifically, human mesenchymal stem cells (hMSCs) from various sources were differentiated into adipocytes (X200, Oil Red O), osteocytes (X100, ARS), or chondrocytes (x40, Alcian Blue), using BI’s MSCgo™ differentiation media (SF,XF).
Figure 1: Suitability of Tissue-Specific hMSCs for Varied Differentiation Outcomes
To learn more about mesenchymal stem cell products offered by Biological Industries, including MSCgo™ and MSC NutriStem® XF Medium, visit: http://www.bioind.com/products/stem-cell-research/.
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