Your Global Leader in Stem Cell Market Research
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).
SAN ANTONIO – StemBioSys Inc. announced today that it has entered into an agreement with VWR (NASDAQ: VWR) to distribute and market StemBioSys products.
VWR, the leading global independent provider of product and service solutions to laboratory and production facilities, will be the exclusive distributor for StemBioSys in both the United States and Canada. [Read more…]
Sydney, Australia – 29 December 2016 – Regeneus Ltd (ASX: RGS), a clinical-stage regenerative medicine company, today announced that it has entered into a strategic collaboration and licensing agreement with AGC Asahi Glass (AGC) (TYO:5201), a world-leading manufacturer of glass, chemicals, high-tech materials and biopharmaceuticals, for the manufacture, clinical development and commercialisation of Progenza, a patented off-the-shelf stem cell technology platform, for the Japanese market.
On November 11, 2016, ReproCELL and Steminent Biotherapeutics entered into a partnership to “develop and commercialize Steminent’s allogeneic stem cell therapy product, Stemchymal, in Japan.”
In this article:
Based on the terms of the agreement between ReproCELL and Steminent:
The timing of this partnership is significant because the “Act on the Safety on Regenerative Medicine” and revisions to the “Pharmaceutical and Medical device Act” took effect in Japan in 2014. There are subtle, but important differences between these two acts and how they support regenerative medicine development in Japan.
The aim of the Act on the Safety of Regenerative Medicine is to accelerate the clinical application and commercialization of regenerative products, including cell and gene therapies, as well as tissue engineered products. It covers clinical research and medical practice using processed cells and specifies the procedures required to deliver these cells to humans.
In contrast, the PMD Act introduces a regulatory framework for regenerative medicine products. It allows for conditional and time-limited marketing approval to be given to a regenerative medicine product after exploratory clinical trials have demonstrated probable benefit and proven safety.
Under these new laws, once a company has demonstrated safety and basic efficiency data in humans and the cell product can be manufactured to the standards described within the Pharmaceutical and Medical Devices (PMD) Act, the cell therapy can be awarded conditional approval for up to 7 years. This allows for the commercial use of the cell product with data reporting requirements and potential for national insurance coverage.
Japan also accelerated its position as a hub for regenerative medicine research with support from Prime Minister Shinzo Abe, who identified regenerative medicine and cellular therapy as key to Japan’s strategy to drive economic growth. The Prime Minister has encouraged a growing range of collaborations between private industry and academic partners through an innovative legal framework approved last fall.
These regulatory changes have the potential to speed up the commercialization of cell therapies within Japan by allowing “time-limited conditional approval.” Assuming safety and probable efficacy have been demonstrated during early-stage clinical trials, companies are permitted to sell cell therapy products within Japan while continuing late-stage clinical trials.
According to REPROCELL’s recent press release, this is the first time that REPROCELL will compete within the regenerative medicine market, within Stemchymal representing its first pharmaceutical product.
If all goes as planned, ReproCELL and Steminent state that they will:
Under the financial terms of the agreement:
To learn more, click here to view the full announcement issued by ReproCELL and Steminent.
In your opinion, how has Japan’s attitude towards regenerative medicine affected stem cell research? Share your thoughts in the comments section below.
Up Next: How to Find a Stem Cell Clinical Trial for Your Condition?
Editor’s Note – This post was originally published on December 26, 2016 and has been updated for quality and relevancy.
On December 6th, MD Anderson Cancer Center and NIH announced that they will be funding a clinical trial that will combine two Mesoblast technologies:
The purpose of the trial is to provide clinical data to indicate whether these technologies can interact synergistically to promote faster cord blood HSC engraftment for bone marrow transplant patients. [Read more…]
RoosterBio is an innovative mesenchymal stem cell (MSC) company that is focusing on democratizing stem cell manufacturing and ushering in a new era of regenerative medicine. 2016 has been a massive year for the company, as it recently announced a collaboration with BioBridge Global, as well as a co-branding partnership with the global filtration, separation and purification leader, Pall Corporation. [Read more…]
