ReproCELL Archives | BioInformant

Generation of iPSC-derived Parkinson’s Disease Neurons

May 28, 2020 By Cade Hildreth, Founder & President 6 Comments

Author: Jean-Philippe Richard, Ph. D. ([email protected])

Parkinson’s Disease (PD) affects some 10 million people worldwide, most commonly in patients over the age of 50. PD is associated with the loss of dopaminergic neurons in the substantia nigra region of the brain, leading to the characteristic tremors in the extremities, among other symptoms. There is a need for models of PD to help discover new therapies. To help address this need, we generated and characterized iPSC-derived PD dopaminergic neurons as a test case for functional neural differentiation. [Read more…]

Steminent Announces Japan partner ReproCELL has PMDA Approval of CTN for Phase II Trial of Stemchymal® SCA in the Treatment of Spinocerebellar Ataxia in Japan

August 7, 2018 By Cade Hildreth, Founder & President 1 Comment

San Diego, CA, USA, August 1st, 2018 – Steminent Biotherapeutics Inc. (“Steminent” or “Company”) a private, clinical-stage cell-therapy company with offices in Taiwan, San Diego and Shanghai, is pleased to announce that the Clinical Trial Notification (“CTN”), submitted by their Japan partner; ReproCELL, to the Japan Pharmaceuticals and Medical Device Agency (“PMDA”) for a Stemchymal® SCA Phase II clinical trial for Polyglutamine Spinocerebellar Ataxia (“PolyQ SCA”) has been approved. This is another key milestone for Steminent’s international Stemchymal® SCA Phase II clinical development program with trials now moving ahead in Taiwan, US, and Japan. [Read more…]

How iPSCs are Becoming an Emerging Area of Stem Cell Research

April 11, 2018 By Cade Hildreth, Founder & President Leave a Comment

Since the discovery of induced pluripotent stem cells (iPSCs) in 2006, a large and diverse market for iPSC research tools has emerged. Included below is a ten-year history of iPSC grants (source: RePORT.NIH.gov), clinical trials (source: ClinicalTrials.gov), and scientific publications (source: PubMed.gov).

Both graphs below reveal the iPSC market is expanding. [Read more…]

ReproCELL and Steminent Partner to Commercialize Stemchymal in Japan

December 26, 2016 By Cade Hildreth, Founder & President Leave a Comment

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.”

ReproCELL and Steminent Partnership

In this article:

ReproCELL in Japan
Repro Therapeutics Advancement
Financial Aspects of the Agreement Between ReproCELL and Steminent for Development of Stemchymal

ReproCELL in Japan

Based on the terms of the agreement between ReproCELL and Steminent:

ReproCELL will get exclusive rights for the development and commercialization of Stemchymal for treating Spinocerebellar ataxia (“SCA”) in Japan
ReproCELL will have right of first negotiation for the development and commercialization of Stemchymal for other disease indications

Japan and Regenerative Medicine

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.

Time-Limited Conditional Approval

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.

Repro Therapeutics Advancement

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:

Initiate clinical trials for Stemchymal in 2017
Secure “time-limited conditional approval” in 2020
Receive marketing approval in Japan by 2023

Financial Aspects of the Agreement Between ReproCELL and Steminent for Development of Stemchymal

Under the financial terms of the agreement:

ReproCELL will invest US$1M in Steminent as an allocation of new shares to a 3rd party
REPROCELL will pay development milestones which will total approximately US$4M
REPROCELL may make royalty payments during the commercialization of Stemchymal

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.

[Case Study] ReproCELL as an Early Competitor within the Induced Pluripotent Stem Cell (iPSC) Marketplace

December 9, 2015 By Cade Hildreth, Founder & President Leave a Comment

ReproCELL Enters iPSC Marketplace by 2009

In 2006, Shinya Yamanaka’s lab at Kyoto University in Japan created the first induced pluripotent stem cells (iPSCs) from mouse cells. By 2007, a series of follow-up experiments had been competed at Kyoto University in which human adult cells were transformed into iPSCs. Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells.

Just a couple years later in 2009, a forward-thinking company, ReproCELL, entered the iPSC marketplace. At that time, the scientific community was just beginning to explore the cell type, including how to derive, maintain, and differentiate iPSCs.

Established in 2003 as a venture company originating from the University of Tokyo and Kyoto University, ReproCELL was the first company to make induced pluripotent stem cell (iPSC) products commercially available with the launch of its human iPSC-derived cardiomyocytes, which it called “ReproCario.” Other stem cell derived cardiomyocytes are now available commercially from Cellular Dynamics International, GE Healthcare, Cellectis, and others.

ReproCELL’s Commercialization of Induced Pluripotent Stem Cell (iPSC) Products

ReproCELL’s innovation in the area of iPSC commercialization has been driven in part by joint research relationships it established in 2003 with Tokyo University and in 2004 with Kyoto University, the eventual site of iPSC discovery in 2006. Since 2009, ReproCELL has expanded its line of iPSC reagents and iPSC-derived cell lines to include heart, liver, and nerve cells.

The company primarily sells these products as research tools, although they also have the potential for use in toxicology and drug discovery applications. Currently, ReproCELL offers the following iPSC products:

Research reagents optimized for human iPSC culture
Human iPSC-derived cardiomyocytes, which launched in April of 2009 (the first iPSC product to be sold commercially)
Human iPSC-derived neurons, launched in October of 2010
Human iPSC-derived hepatocytes, launched in May of 2012
Disease model cell generation using human iPS cell technologies

ReproCELL Expands Through Strategic Acquisitions

To date, ReproCELL has furthered its dominance in the area of iPSC products through a series of strategic acquisitions, including acquisition of Reinnervate, BioServe Biotechnologies, and Stemgent, and all occurring in 2014. Over time, ReproCELL has acquired a growing selection of smaller companies, making strategic acquisitions one of its primary techniques for marketplace dominance and company growth.

Most recently, on November 24, 2015, ReproCELL announced that it would be expanding its drug discovery services through its acquisition of the firm Biopta. Based in Glasgow, UK, and Maryland, USA, the Biopta Group describes itself as “providing contract research services to the pharmaceutical industry since 2002 and has established itself as the world leader in the use of fresh functional human tissues to better predict drug activity prior to clinical trials.”

Click here to read the full press release about the event, titled “ReproCELL Acquires Biopta to Expand its Drug Discovery Services.”

To learn more about emerging trends and opportunities within stem cell markets, view our global strategic reports for the stem cell and cord blood industry.