What are Mesenchymal Stem Cells (MSCs)?
Before we delve into the advantages of using mesenchymal stem cells (MSCs) for therapeutic applications, let’s begin with a quick explanation of what they are.
These cells, which are also known as mesenchymal stromal cells, were first discovered by Friedenstein and his colleagues in 1976 from bone marrow, and have since become an increasing focus of stem cell research and therapies.
According to the International Society for Cellular Therapy (ISCT), MSCs are defined as cells that follow these minimal criteria:
- They must be plastic-adherent when maintained in standard culture conditions
- They must express CD105, CD73, and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79a or CD19 and HLA-DR surface molecules
- They must differentiate into osteoblasts, adipocytes, and chondroblasts in vitro
Why are hMSCs Ideal for Therapeutic Applications?
hMSCs have a unique capacity for use in therapeutic applications for multiple reasons, including:
- They are immuno-privileged
- They can be easily sourced from a wide range of tissues
- They have the ability to migrate to tumors and wounds in vivo
- They secrete factors that can stimulate tissue repair
- They can substantially alter their microenvironments to exert anti-inflammatory and anti-fibrotic effects
- They avoid the ethical issues that surround the embryonic stem cell research
- They are well-suited for use in 3D printing due to their unique capacity to form human structural tissues
As a result of these advantageous traits, hMSCs are considered to be ideal tools for use in tissue engineering and cell-based therapy applications.
Why is hMSC Culture Medium Important as an Ancillary Material for Cell-Based Therapies?
Due to the fact that hMSCs are usually expanded in culture before their use in most clinical applications, the quality and performance of the culture mediums used are crucial in regards to therapeutic use. The reason for this is that the medium components and the culture conditions can significantly affect hMSC properties.
In most cases, culture media for the growth and expansion of these cells, together with auxiliary solutions used for attachment, dissociation, and cryopreservation, need to be supplemented with xenogeneic compounds including serum.
For these reasons and more, the use of a defined xeno-free (XF), serum-free (SF) culture system that is optimized for hMSC isolation and expansion can greatly facilitate the advancement of a more robust, clinically-acceptable culture process for the generation of quality-assured cells.
Meet Biological Industries’ NutriStem® MSC Xeno-Free Culture Medium
In order to meet the challenges of translating hMSC research into practical therapeutic applications, BI developed a novel, xeno-free (XF) culture system. This culture system comprises MSC NutriStem® XF culture medium, together with all of the required auxiliary solutions that support the attachment, dissociation, and cryopreservation of hMSC.
This advanced system has been evaluated for the initial isolation of hMSCs from different sources, and for the long-term culturing under SF, XF culture conditions that are suitable for clinical applications. Research also shows that BI’s MC NutriStem® XF culture system supports the initial isolation and the optimal expansion of hMSC from different sources.
Moreover, in 2015, BI successfully submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) with the goal of certifying its MSC NutriStem® XF Medium for clinical applications. DMFs are prepared by pharmaceutical manufacturers and are submitted to regulatory authorities in markets where the products are sold. This document provides regulators with confidential and detailed information about facilities, articles, and processes used in the manufacturing, processing, packaging, and storing of the relevant products.
In a regulatory context, MSC NutriStem® XF is classified as an “ancillary material”. This means that it is used in the process, but is not a part of the final product. According to the four-tied USP Risk classification system, MSC NutriStem XF is classified as low-risk when produced in compliance with GMPs.
By the acceptance of this DMF by the FDA, BI demonstrated its ongoing commitment to providing customers with innovative, high-quality, and certified solutions. NutriStem® is produced according to superior quality standards, undergoes extensive and stringent quality control testing, and is functionally characterized for performance in relevant cell models. Also, in addition to benefiting from guaranteed lot-to-lot repeatability, NutriStem® customers receive a certificate of analysis as well as DMF cross-reference.
With BI’s NutriStem® Cell Culture Media, You Can Give Your Cells the Competitive Edge they Need
As discussed, the key to achieving successful stem cell cultures is using protocols that integrate high-quality and xeno-free reagents. That said, and despite the fact that MSC research constitutes a quickly progressing field of medicine, clinical applications are still limited as the result of xeno contamination that occurs during in vitro derivation and propagation processes.
This gap between research and the therapeutic application of hMSCs can be bridged through the design and implementation of qualified protocols and operating processes – with xeno-free and animal component-free media as a critical component in the translation of hMSC therapies into human subjects.
With this in mind, BI developed its MSC NutriStem® XF medium as a defined, serum-free, xeno-free culture medium. This medium promotes the optimal growth and expansion of hMSCs derived from different sources including (but not limited to): bone marrow (BM-hMSC), umbilical cord matrix (UC-hMSC), adipose tissue (AT-hMSC), Wharton’s jelly (WJ-hMSC), dental pulp (DP-MSC), and placental tissue (PT-hMSC).
hMSCs cultured in MSC NutriStem® XF medium maintain the following features:
- Proper fibroblast-like cell morphology
- Tri-lineage differentiation potential
- Normal hMSC marker profiles
- Karyotypic stability over long-term culture
In addition, they demonstrate superior self-renewal and proliferation potential as compared to that of serum-containing media and other types of commercial serum-free media.
In a Nutshell, What Makes MSC NutriStem® XF Ideal for Isolating and Growing hMSCs?
To summarize, the following traits make MSC NutriStem® XF ideal for isolating and growing hMSCs:
- It is classified as ancillary material for cell therapy and has been used in multiple clinical applications
- It is produced in a cGMP compliant facility
- It is suitable for hMSC derived from multiple different sources
- It is xeno-free
- It is accompanied by a Drug Master File (DMF)
The growing need to translate hMSC research into clinically-relevant therapies calls for a proven, serum-free (SF), and xeno-free (XF) culture system that is optimized for such applications. As described above, BI’s MSC NutriStem® XF medium answers this definition and is the ideal solution for the isolation and expansion of hMSCs.