The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]
Mesenchymal Stem Cells (MSCs)
Mesenchymal stem cells (MSCs) are a well-characterized population of adult stem cells that can differentiate into a variety of cell types (chondrocytes, osteoblasts, adipocytes, myocytes, and more).
Understand Stem Cell Market Needs, so You Can Precisely Meet Them – with Minimal Time, Cost, and Risk
As a provider of stem cell products and technologies, you know you need to:
- Make effective product development decisions
- Sell more effectively
- Generate improved revenues
- Take market share
Without strategic guidance on which to base your actions, you’re in a difficult position. New products that don’t sell well are costly mistakes. On the other hand, repeatedly launching high-demand products and skillfully addressing the unmet needs of your clients is certain to position you as a market leader.
[Read more…]
Commence Bio Receives 1st Patent for MSC1, An Innovative Cancer Immunotherapy Platform
In major news released this week, Commence Bio announced that the company has received its first patent for MSC1. Commence Bio is a pre-clinical stage biotechnology company that is based on the concept that cancer and other inflammatory conditions can be addressed by “rebooting patients’ immune systems” with a new class of medicinal stem cells, MSC1 and MSC2.
The company is now developing a therapeutic pipeline, as well as offering research products that include MSC1 and MSC2 cells and media. The concept around which the company is based is that its proprietary “stimulated Toll-like receptor technology” programs naïve MSCs to either a more potent anti-inflammatory phenotype, or a new pro-inflammatory, anti-tumor phenotype. [Read more…]
Stem Cell News You Need to Know – Innovation, Regulation, and Consolidation
The stem cell industry is an exciting and rapidly-changing sector, so we have released new content that we are excited to share with you. Covered below is information about the upcoming September 8th Public Workshop at the FDA, as well as articles highlighting regulatory advances, new product launches, industry mergers, world firsts, and the new and emerging market for dental stem cells.
Enjoy and let me know what you think!
According to the FDA, the purpose of the public workshop is to identify and discuss scientific considerations and challenges to help inform the development of human cells, tissues, and cellular and tissue-based products (HCT/Ps) subject to premarket approval, including stem cell-based products. I got my registration confirmation this week and hope to see a ton of you there. You can get information here or register at this link.
Axiogenesis Supports CiPA’s Aim to Improve Current Regulatory Guidances
Human stem cell-derived cardiomyocytes are particularly important for preclinical cardiac safety assessment. While several independent groups have derived human cardiomyocytes from iPSCs, there are only a few commercial providers that specialize in these cells types. Cellular Dynamics International (CDI) is the best-known American provider, while Axiogenesis has grown into a dominant European provider of these cell types. A unique attribute of Axiogenesis is that the company actively participates in validations in public consortia, such as the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative.
RoosterBio has announced the launch of a new xeno-free version of exceptionally efficient human mesenchymal stem/stromal cell (hMSC) expansion medium. This xeno-free media formulation extends RoosterBio’s portfolio of bioprocess media engineered to streamline culture processes, minimize processing time, significantly decrease production costs, reduce regulatory burden and simplify the transition into scalable platforms for clinical and commercial adult stem cell manufacturing.
Based in South Africa, Next Biosciences is a unique company. It owns Netcells, Africa’s largest private stem cell bank. It also recently merged with a local laboratory, Genesis Genetics, making Next Biosciences the only facility on the African continent to offer genetic and metabolic screening, as well as storage of umbilical cord blood and tissue. The merger of these local leaders in stem cell banking and genetic testing consolidates their position within the African biotechnology industry.
Transplant Marks 1st Release of a Privately Stored Stem Cell Sample from UAE to the United States
The CryoSave European flagship company was established in 2000 and operates laboratories in Switzerland, Dubai, Netherlands, Belgium, Germany, South Africa, and Portugal. As of 2016, they have processed more than 300,000 cord blood samples, the largest number in Europe. CryoSave Arabia, part of the global CryoSave network, was officially launched in 2006, by the UAE Minister of Health and now operates the region’s largest private laboratory and cryogenic preservation facility. In a world first, CryoSave Arabia announced that it has supplied the first privately stored stem cell sample released from the UAE to the United States.
Why the Dental Stem Cell Market is Growing (And Who Is Dominating It)
Dental pulp is the soft living tissue inside a tooth that contains mesenchymal stem cells (MSCs). BioEden began offering tooth stem cell storage as early as 2006, making it one of the earliest known providers of dental stem cell storage. The National Dental Pulp Laboratory launched shortly thereafter in 2007. The dental pulp storage market is still relatively small, because of the early stage of research concerning the use of dental pulp stem cells. However, it is a growing area, as an average of 1-2 new providers are now entering the global marketplace every month.
Mesenchymal Stem Cells – Advances & Applications – Global Strategic Report; 250 Pages
Mesenchymal stem cells (MSCs) are one of the fastest growing areas of stem cell research. They are now more frequently cited than any other stem cell type within the scientific literature. Google Trend data also shows MSC searches to be approximately twice as common as the next most common adult stem cell type. The market for MSCs is growing. Are you informed about market opportunities and ready to act on them now?
About BioInformant
BioInformant is the first and only market research firm to specialize in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, Medical Ethics, Vogue Magazine, and more. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, and Goldman Sachs, BioInformant is your global leader in stem cell industry data.
Cynata Prepares for Phase 1 Clinical Trial of iPSC-derived MSC Product CYP-001
Australian stem cell company Cynata Therapeutics announced that it plans to file an application for regulatory approval within the UK to initiate a Phase 1 clinical trial of its iPSC-derived MSC product CYP-001 in July 2016.
This is a significant announcement, because it will be the world’s first allogeneic iPSC clinical trial.
Cynata’s Cymerus™ technology utilizes iPSCs originating from an adult donor as the starting material for generating mesenchymoangioblast (MCAs), and subsequently, for differentiating the cells into mesenchymal stem cells (MSCs). The outcome is that Cynata can produce MSCs in unlimited quantities, in uniform batches, from a single donor, and at low cost. The company’s lead product produced using the s Cymerus™ technology is CYP-001.
This clinical trial will also be the first time that the company’s unique Cymerus technology is tested in humans.
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