News & Events

In the fast pace world of cutting-edge science, access to timely information is paramount.  Nowhere is this more critical than with stem cell technologies, drug discovery and regenerative medicine.  Let REPROCELL keep you informed about newsworthy information and events which may be of interest to you, by visiting our News & Events webpage. 



REPROCELL News

Jul 30, 2018

Announcement on the PMDA Approval of CTN for Phase II Clinical Trial of Stemchymal® in Japan

REPROCELL is pleased to announce that the Clinical Trial Notification (“CTN”) which was submitted to the Japan Pharmaceuticals and Medical Device Agency (“PMDA”) for Phase II clinical trial for Polyglutamine Spinocerebellar Ataxia (“PolyQ SCA”) in Japan has been approved. This allows REPROCELL to initiate Phase II clinical trial of Stemchymal® in Japan.

PolyQ SCAs, which are classified to Spinocerebellar Disease (“SCD”), are rare neurodegenerative diseases for which no effective medication is available. Neuronal degenerations are observed in the cerebellum and the spinal cord which cause progressive ataxia such as gait disorders, dysphagia, and dysarthria.

Stemchymal® has shown potential efficacy to suppress and improve ataxia symptoms in PolyQ SCA patients. Previous phase I/II clinical trial in Taiwan, which was conducted by Steminent, has suggested the safety and potential efficacy of Stemchymal® for PolyQ SCA patients. In addition, Steminent has recently received approval from the United States Food and Drug Administration (“FDA”) of Investigational New Drug (“IND”) application for phase II clinical trial of Stemchymal® for PolyQ SCA patients in the US. REPROCELL will also, in the phase II clinical trial approved by the PMDA, evaluate safety and efficacy of Stemchymal® for patients in Japan.

In Japan, the “Act on Pharmaceutical and Medical Device” and the “Act to Ensure Safety of Regenerative Medicine” have come into effect in 2014. Under this new system, the “Time-limited Conditional Approval”, which allows one to conditionally sell regenerative medicine products while continuing following clinical trials, could be obtained by showing safety and potential efficacy of the product in clinical trials. This new system is expected to accelerate the development of regenerative medicine products in Japan.

REPROCELL will now prepare for clinical trial sites to recruit eligible patients in Japan and will aim to leverage the new system in Japan to obtain fast-track approval. We will continue to strive to contribute to the welfare of patients who are fighting with their conditions.

Apr 03, 2018

Announcement: REPROCELL launches “ReproMed™ iPSC Medium”, a Culture Medium for Human iPS Cells in Regenerative Medicine

We are pleased to announce the launch of “ReproMed™ iPSC Medium” in April 2018, a human iPS cell culture medium for regenerative medicine that can be used in clinical purposes.

The reagents used for the manufacturing of regenerative medicine products are required to have a high level of safety, such as eliminating the risk of virus infections and use of toxic substances.

ReproMed iPSC Medium consists only of components and materials that are scientifically safe and has cleared the standard for bio-safety guidelines and verified by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the inspection agency of pharmaceutical affairs under the Ministry of Health, Labor and Welfare.

This product also has outstanding capability. Efficient differentiation of iPS expanded and cultured with ReproMed iPSC Medium into cardiomyocytes, neurons, and hepatocytes has been confirmed, proves that this is a suitable culture medium for the clinical purposes.

Together with the 3rd generation reprogramming technology as well as “ReprpCryo RM”, a cryopreservation solution which already has a master-file, we will equip ourselves with comprehensive technical platform for regenerative medicine and clinical application for iPS cells, enable us to accelerate our presence in the field of regenerative medicine.

REPROCELL will continue to put our efforts in the clinical application not only through the supply of the products suitable for the regenerative medicine, but we also utilize these products in our own workflow in the field of regenerative medicine, which is in line with our growth strategy in the expanding clinical and regenerative medicine market segment.

The development of ReproMed iPSC Medium was partly supported by the project budget of “Project Focused on Developing Key Evaluation Technology for the Industrialization in the Field of Regenerative Medicine and Manufacturing Technology for Industrialization in the Field of Regenerative Medicine” by the Japan Agency for Medical Research and Development (AMED).

Jan 17, 2018

RIKEN BioResource Center (Japan) collaborates with REPROCELL for disease-model cell services

The RIKEN BioResource Center (BRC) has an iPS cell bank with a wide range of disease-specific iPSC that have been generated from patients with various disease backgrounds.  REPROCELL has the experience and capacity to differentiate iPSC into functional cells such as neurons, cardiomyocytes, hepatocytes and others.

As defined in the agreement, REPROCELL will be a preferred supplier of differentiation services for clients of the RIKEN BRC.  Upon a client's request, the banked iPSC from the RIKEN BRC will be provided to REPROCELL for cell preparation specific to the client's request.  The relationship will benefit all parties involved, leverage resources and strengths of both the RIKEN and REPROCELL.

Jan 15, 2018

REPROCELL launches new global website

Today, REPROCELL rolled out its new comprehensive global website demonstrating the synergies and power of the full portfolio of products and services. The old websites of Stemgent, BioServe, Reinnervate and Biopta are no more with all customer web-searches redirected to the new global https://reprocell.com pages. The new website is loaded with information and features covering all brands, provided in a way that viewing and searching is more productive and informative. Also improved is the e-commerce online ordering experience (for USA customers only).


The Japan language website has been moved to make room for the new global website.  Powered by a new server and listed under a new domain (https://reprocell.co.jp), the Japan website speed and performance has also been dramatically improved.


The company has also refreshed and integrated all the social media sites under the REPROCELL brand for the global market. Using a single Facebook, LinkedIn and Twitter account, the news from Japan and all international sites is now coordinated and announced on unified accounts. 


These digital infrastructure improvements and others are expected to improve the cross-sales of products and services in the global market, increasing revenue and positioning REPROCELL as a fully integrated stem cell and drug discovery company.

Oct 27, 2017

REPROCELL Chooses Science Exchange as the Preferred Partner to Increase Accessibility of its Predictive Drug Discovery Services

Science Exchange (Palo Alto, CA), the world’s leading and most secure enterprise platform for outsourced research services and procurement of human biospecimens, announced that REPROCELL has selected the Science Exchange platform as the primary marketplace to offer access to its predictive drug discovery assays for the biopharma research community.

With REPROCELL as one of Science Exchange's qualified marketplace service providers, researchers now have access to a diverse range of preclinical assay services using fresh human tissues, stem cells and 3D models which offer the biopharma industry novel tools for investigating the safety and efficacy of new drug candidates early in the drug discovery process.

Through the Science Exchange platform, researchers are empowered to focus on innovation, while Science Exchange takes on the role of supporting the identification of new and novel service providers such as REPROCELL, management of a secure contracting process, and delivery of analytics to track performance and inform process improvement. 

About Science Exchange

Science Exchange is the world's leading and most secure platform for outsourced research, providing an efficient procure-to-pay platform for ordering 6,000+ services from a network of more than 2,500 qualified scientific service providers, all with pre-established contracts in place that protect client intellectual property and confidentiality. The platform increases access to innovation and improves productivity, freeing scientists from administrative tasks and delays associated with sourcing, establishing and managing service provider contracts. Additionally, the Science Exchange enterprise program enables large R&D organizations to consolidate research outsourcing spend into a single strategic relationship, driving efficiency, improving transparency and oversight, and delivering cost savings. Since being founded in 2011, Science Exchange has raised more than $58 million from Norwest Venture Partners, Maverick Capital Ventures, Union Square Ventures, Collaborative Fund, Index Ventures, OATV, the YC Continuity Fund, and others. For more information, visit www.ScienceExchange.com.

Sep 27, 2017

European Pharmaceutical Review Article by David Bunton, CEO, REPROCELL Europe

REPROCELL Europe Ltd’s CEO, Dr David Bunton, has published an article titled "New Strategy" in the European Pharmaceutical Review, Autumn 2017.

The article is in the Applied Research, Development and Production section of the EPR Journal. It is co-authored by David Bunton at REPROCELL Europe, Marian McNeil at Stratified Medicine Scotland and Pamela Brankin at Aridhia.

The abstract:

To move away from ‘all-comers’ trials, the early identification of genetic factors influencing effectiveness in patient subpopulations is key. A recent increase in the use of predictive human tissue models led to the idea for a nationwide multidisciplinary collaboration that combined assays in fresh, diseased human tissues studied ex vivo, with whole exome sequencing. This allowed genomic markers to be recognised, distinguishing patients identified by the human tissue assays as ‘good’ or ‘poor’ responders. 

This Scottish pharmacogenomics project has made great strides in the understanding of chronic obstructive pulmonary disease (COPD) and inflammatory bowel diseases (IBD) by using whole exome sequencing, bioinformatics and fresh human tissue assays to relate drug response to genotype. The study findings underpin a new framework for patient stratification in clinical trials that combines in vitro and molecular informatics to improve pharma success rates and accelerate the availability of effective medications. 

The most common cause of drug failure is poor efficacy at Phase 1 or 3, which is, in part, attributed to clinical trials of entire patient populations, including both ‘responders’ and ‘nonresponders’ (1,2). Precision medicine can improve the prediction of clinical efficacy by selecting only those patient subpopulations likely to gain clear benefit for trials, but such forecasts require methods to identify patient subpopulations at an early stage, ideally during preclinical testing (2-4). Human tissue data generated in early discovery via a wide range of models – including stem cells, fresh human tissues and pathological specimens – is increasingly being used in preclinical testing (5-7). Tissue samples collected from the target patient population allow researchers to directly test the effect of new drugs in systems that closely reflect the in vivo situation, providing an early prediction of efficacy. The responses of tissues from different patients when studied in vitro can vary considerably, reflecting the clinical reality of responders and non-responders. 

Sep 12, 2017

Notification of Clinical-use iPS Cell Freezing Medium “ReproCryo RM” Japan Master File Record Completed

The clinical-use-qualified iPS cell freezing medium "ReproCryo RM", which became commercially available earlier this year from REPROCELL, has been registered in a master file of the PDMA, an independent administrative corporate body dedicated to safety and regulatory compliance of medical products and services in Japan.  The Master File contains details of the components and raw materials, and data of ReproCryo RM medium, as a confidential reference file for regenerative medicine companies in Japan.  Furthermore, the results of the concurrent acute toxicity trials (non-clinical) on the product have also been released.

Reagents used in the production of clinical iPS cells need to be of the highest quality and safety.  ReproCryo RM is composed of ingredients that are chemically non-hazardous.  Unlike other cryopreservation medium, it does not contain DMSO, an ingredient with associated concerns over cell toxicity and mutagenicity.  Moreover, the product has already been confirmed, as of January 2017, to comply with all the PDMA standards for biologically-derived materials.  And the recent toxicity testing which involved intravenous administration of ReproCryo RM into rats is now complete, with no acute toxicity being detected.

ReproCryo RM shows high performance with iPS cells and is produced in a facility conforming to (GMP) standards for medical grade manufacture and quality control. Since it is now registered with a PDMA master file, and has cleared all regulatory hurdles, the product is an ideal cryopreservation medium for developing cellular or medical products using clinical-grade human iPS cells.

Sep 04, 2017

Delay of the Clinical Trial of Adult Stem Cell Regenerative Medicine in Patients with Ischemic Stroke in Japan announced by Healios K.K.

HEALIOS K.K. (“Healios”) today announces that the patient enrollment of the clinical trial of adult stem cell regenerative medicine HLCM051 (MultiStem®) in patients with acute ischemic stroke in Japan, named the TREASURE study, has been temporarily suspended. The placebo was found to be out-of-specification and is being replaced, which is expected to take approximately one month. The placebo material, which had an incorrect concentration of a media component, had not been administered to subjects and did not present a safety issue. Athersys Inc. (“Athersys”), the supplier of the investigational product, identified the issue and promptly notified Healios, which informed the open sites of the temporary suspension of patient enrollment on the same day, after confirming that none of HLCM051 nor placebo product had been administered. Healios (www.healios.co.jp/en) received the report from Athersys (www.athersys.com) that incorrect placebo manufacturing instructions were utilized by its contract manufacturer. These instructions have been corrected, and replacement placebo material is being manufactured and is expected to be ready for release in about one month following testing and inspection. The placebo will be distributed to the clinical trial sites in accordance with our quality control process in Japan, and then the patient enrollment will be restarted after confirming that the placebo meets required specifications. The new placebo will be distributed to the sites which already completed the preparations for patient enrollment. In addition, there are more than 20 medical institutions where Institutional Review Boards have granted approval to conduct the trial, and the number of the sites to initiate enrollment will be increased sequentially. Healios plans to conduct the trial at over 30 sites throughout Japan. In order to prevent the recurrence of defect or other manufacturing issues, Healios will work closely with Athersys to ensure the thorough management of manufacturing and quality control and oversight of Athersys’ contract manufacturer, and to facilitate the TREASURE study (“Treatment Evaluation of Acute Stroke Using Regenerative Cell Elements”). If matters to be disclosed arise in the future regarding the effect on fiscal year 2017 financial performance, Healios will make an announcement without delay.

This announcement is meaningful and impactful to REPROCELL, since testing of some of the clinical trial patient samples is contracted to REPROCELL labs in Japan.

Aug 15, 2017

Investment in Steminent Biotherapeutics Inc., a Pioneer of Regenerative Medicine in Taiwan, Developing a Cell-Based Therapy for the Treatment of Spinocerebellar Ataxia

Cell Innovation Partners Limited, of which REPROCELL is a member organization, has invested NTD 62 million (JPY 230 million) in Steminent Biotherapeutics Inc. The Company develops cell therapy products for the treatment of multiple diseases including Spinocerebellar Ataxia and Acute Liver Failure. Steminent is the developer of Stemchymal®, allogeneic adipose tissue derived stem cells from healthy donors, which is the most advanced cell therapy product candidate for the treatment of SCA. With the safety of the treatment already confirmed and potential efficacy observed, Stemchymal is currently in a Phase 2 clinical trial for SCA in Taiwan. Steminent is developing Stemchymal not only in Taiwan but also in the United States and Japan. In the United States, the Company is currently working to initiate Phase 2 clinical trials for SCA in 2018. In Japan, REPROCELL has partnered with Steminent and is planning to initiate Phase 1/2a clinical trials for SCA in 2018.

Aug 10, 2017

First Minister of Scotland (Nicola Sturgeon), opens REPROCELL European Headquarters in Glasgow

Glasgow, UK. 10th August 2017: REPROCELL Europe Ltd (REPROCELL), a leading provider of products and services for research in stem cells, drug discovery, human tissues and 3D cell culture and a member of the REPROCELL Group, has opened its European headquarters in Glasgow, UK. The REPROCELL Centre for Predictive Drug Discovery at West of Scotland Science Park was inaugurated by Scotland’s First Minister, Nicola Sturgeon. The new headquarters will enable the company to strengthen its pharmaceutical industry-targeted drug discovery services and translational research, and generate new employment opportunities in Scotland. The company’s relocation to the West of Scotland Science Park was supported by £150,000 of Regional Selective Assistance from Scottish Enterprise in December 2016. Since then, REPROCELL has invested a further £630,000 to expand its European headquarters and develop its product and service offering. REPROCELL has expertise in the development of predictive assays using stem cells, 3D tissue models and fresh human tissues, which offer the pharmaceutical industry novel tools for investigating the safety and efficacy of new drug candidates early in the drug discovery process. The Centre for Predictive Drug Discovery will allow the company to continue to develop these lines of business by growing its Glasgow-based workforce and expand operations to focus on the launch of new services.

Commenting on the company’s new Scottish headquarters Nicola Sturgeon, First Minister of Scotland said:“Life sciences is an exciting and developing growth sector for Scotland’s economy and it is testament to confidence in the sector that REPROCELL has decided to base its European operations here. The jobs that are being created and safeguarded will provide significant benefit to the surrounding area and I am looking forward to seeing the company go from strength to strength in the future.”  

This following YouTube video is taken from an interview with Nicola Sturgeon, First Minister of Scotland, regarding her comments on the new REPROCELL facility:   https://youtu.be/rpHGbgplXC0

Dr David Bunton, CEO of REPROCELL Europe Ltd said: “Scottish Enterprise has worked closely with the company in Scotland, Europe, US and Japan to provide business support. This has included work from SDI field colleagues in Japan and across Europe to help identify potential customers, as well as tailored company support on the ground in Scotland to look at new market opportunities globally and extend existing testing services.”

Rhona Allison, Company Growth Senior Director at Scottish Enterprise, said: “REPROCELL’s new expertise in stem-cell reprogramming and 3D cell culture, together with its world class facilities are a further and significant boost to Scotland’s growing life sciences capabilities. The company’s confidence in Scotland is testament to the country’s global reputation in the sector and we look forward to continuing to work closely with the REPROCELL team to help them realise their growth ambitions.”

Photo: Daisuke Matsunaga, Consul General of Japan in Edinburgh, Scotland, with Nicola Sturgeon, First Minister of Scotland, at the official opening of the Centre for Predictive Drug Discovery, REPROCELL Europe Ltd, with Dr David Bunton, CEO REPROCELL Europe Ltd.

About REPROCELL Europe www.reprocell-europe.com

REPROCELL Europe was created on the 1st of July 2016 from the merger of Biopta Ltd and Reinnervate Ltd. REPROCELL Europe offers the full range of life sciences research products and contract research services of the REPROCELL Group Brands (REPROCELL, Biopta, Reinnervate, Stemgent and BioServe) to markets worldwide. Through the ongoing research and development synergies within the Group, REPROCELL Europe aims to bring to market further unique products and services to accelerate research in stem cells, drug discovery, human tissues and 3D cell culture.

About REPROCELL Inc.  reprocell.com / reprocell.co.jp 

REPROCELL Inc. was established in 2003 in Japan with the goal of contributing to people’s health and welfare through the development of stem cell technologies. REPROCELL is now an integrated international company with products and services spanning the entire workflow of drug discovery and regenerative medicine, with a vision of "Improving human health through biomedical innovation and discovery".

About Scottish Enterprise scottish-enterprise.com

Scottish Enterprise is Scotland's main economic development agency and aims to deliver a significant, lasting effect on the Scottish economy. Our role is to help identify and exploit the best opportunities for economic growth. We support ambitious Scottish companies to compete within the global marketplace and help build Scotland’s globally competitive sectors. We also work with a range of partners in the public and private sectors to attract new investment to Scotland and to help create a world-class business environment.

 

Jul 27, 2017

AMED Agency (Japan) approves REPROCELL R&D collaboration and subsidization for a Regenerative Medicine project on the development of a functional intestinal cell model.

Orally administered drugs are absorbed and frequently metabolized at the intestinal epithelium while passing through the digestive tract. Hence, in the development of new drugs, their absorption in the digestive tract is an important pre-clinical checklist item. Currently, there is a need for better predictive cell model systems that can be used for in vitro testing. REPROCELL’s role in the collaborative project will be to achieve the stable production of high quality human intestinal cells derived from iPS cells and to create a model suitable for pharmacokinetic studies. Under this program, REPROCELL will have some rights to commercialize the technology globally. The project and grant award, will be shared with Tokyo Institute of Technology, with the exact amount yet-to-be-announced.

Jul 27, 2017

AMED Agency (Japan) approves REPROCELL R&D collaboration and subsidization for a project

Project is entitled “Stable Manufacturing of Human iPSC-Derived Three-Dimensional Liver Spheroids Suitable for Pharmaceutical Screening That Can Be Applied to Organ-on-a-Chip and other Devices”.

Guidelines for pharmaceutical development require that candidate compounds be tested for toxicity and other characteristics using human liver cells. However, the supply of liver cells is unstable, and additionally, there are the issues of rapid decay in function after sampling, as well as variability between lots due to dissimilar donor genetics. The research project aims to develop techniques for the cultivation, mass production, and cryopreservation to enable a stable supply of highly-functional human iPSC-derived liver cells as three-dimensional spheroids that can be used practically for devices and pharmaceutical screening. Under this program, REPROCELL will have rights to globally commercialize the technology. The project and grant award, will be shared with Yokohama City University, with the exact amount yet-to-be-announced.

Jul 13, 2017

Innovate UK Subsidy to REPROCELL Europe

REPROCELL Europe, a consolidated subsidiary company of REPROCELL Inc., has been awarded a subsidy from the UK Department of Business, Energy and Industrial Strategy (Innovate UK).  The Innovate UK Grant is a subsidy intended to support application of innovative technological resources held by UK companies to foster economic growth and development in the UK.  Using this grant, REPROCELL Europe will strive to develop products and assays utilizing the Alvetex 96-well insert together with a three-dimensional skin model for innovative applications in drug discovery.  The value of the grant can be worth up to £60,000 depending on the project spending.

May 24, 2017

REPROCELL and Fox Chase Cancer Center partner to open multi-site Biosample Repository in India

REPROCELL and Fox Chase Cancer Center announced a joint venture to open a multi-site bio-sample repository facility in India. Initial operations are underway in Delhi with plans to expand to Hyderabad in the fourth quarter.  The joint venture will provide a quality source of clinically annotated tissue specimens from the vast Indian population.

“The research community’s demand for access to clinical-grade bio-specimens from India has gone largely unmet. Through our partnership with Fox Chase, we plan to change that,” said Rama Modali, CEO of REPROCELL USA. “We’ve begun growing our inventory of bio-samples in India using the same rigorous quality-assurance standards we employ at our facilities in the US, including the collection and storage of all associated annotated clinical and genetic information and bioinformatics data analytics.”

The joint venture’s India facilities add approximately 3,000 new bio-samples monthly. Collected specimens are supported by annotations that include medical history, mutation data and detailed records of treatment protocols as well as outcomes.

“This alliance further augments our already impressive and extensive combined bio-sample inventory, helping us better serve the global cancer research community,” said Richard I. Fisher, MD, president & CEO of Fox Chase Cancer Center.

As a leading provider of biomaterials, REPROCELL is deeply engaged with cancer and other disease research being conducted by pharma, biotech and leading academic research institutions worldwide.

About Fox Chase Cancer Center:

The Hospital of Fox Chase Cancer Center and its affiliates (collectively “Fox Chase Cancer Center”), a member of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship and community outreach. For more information, call 1-888-FOX CHASE or (1-888-369-2427).

May 04, 2017

REPROCELL and Fox Chase Cancer Center form Strategic Alliance to accelerate Biomarker and Genetic Discovery

REPROCELL and Fox Chase Cancer Center announced a strategic alliance aimed at accelerating oncology discovery and translational studies. Through this alliance, REPROCELL will augment its Global Repository of biospecimens with samples from the Fox Chase Cancer Center, ensuring that researchers have access to the widest array of clinical-grade biospecimens.  The Alliance will provide wider access to oncology biospecimens to accelerate discovery and translational studies.

“REPROCELL’s alliance with Fox Chase ensures that the oncology research and development market has access to a premium source of clinically annotated tissue specimens,” said Rama Modali, CEO of ReproCELL USA. “The scope and sustainability of specimens collected by Fox Chase is as unique as it is impressive, covering nearly every major solid tumor type.”

Today, industry and academia need access to clinical data and biospecimens to accelerate discovery and translational studies. Internationally renowned for cancer research and treatment, Fox Chase Cancer Center also serves as the center of a comprehensive patient care network covering the densely populated three-state region surrounding Philadelphia. As a result, tissue and blood specimens collected for the repository can trace each anonymized patient’s pathway from pre-diagnosis to treatment and through long-term follow-up care. Fox Chase specimens collected at each stage are supported by annotations that include medical histories, detailed records of treatment protocols as well as outcomes.

“Our biosamples have tremendous clinical value, and getting them into the hands of as many cancer researchers as possible is a priority for us,” said Richard I. Fisher, MD, president & CEO of Fox Chase Cancer Center. “We know that making our biosamples available to the wider scientific community will accelerate the pace of cancer research.”

As a leading provider of biomaterials, REPROCELL is deeply engaged with cancer research being conducted by pharma, biotech and leading academic research institutions worldwide.

About Fox Chase Cancer Center:

The Hospital of Fox Chase Cancer Center and its affiliates (collectively “Fox Chase Cancer Center”), a member of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center’s nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship and community outreach. For more information, call 1-888-FOX CHASE or (1-888-369-2427).

Apr 13, 2017

REPROCELL Adding Fox Chase Samples to Biospecimen Repository

REPROCELL announces the addition of samples from the Fox Chase Cancer Center to its global repository of biospecimens in a collaboration designed to advance cancer discovery research and translational studies. The value of the strategic alliance was not disclosed.

“Our biosamples have tremendous clinical value, and getting them into the hands of as many cancer researchers as possible is a priority for us,” Richard I. Fisher, M.D., Fox Chase’s president and CEO, said in a statement. “We know that making our biosamples available to the wider scientific community will accelerate the pace of cancer research.”

Fox Chase maintains a Biosample Repository Facility designed to provide tissue-based research services to support translational and basic research. Those services include tissue microarray construction and immunohistochemistry, automated tissue image analysis, and electrochemiluminescent enzyme-linked immunosorbent assay-based biomarker analysis.

The REPROCELL USA (Bioserve Division) makes available (for research) blood specimens—including whole blood, plasma, leukocytes, lymphoblastoid cell lines, and DNA isolated from leukocytes—as well as tissues such as fresh frozen tissue, fixed paraffin-embedded tissue, multitissue microarrays and tumor DNAs.

According to Fox Chase, the Facility also coordinates the ethical collection, storage, annotation, and distribution of human biosamples, as well as associated comprehensive patient and family cancer history data, clinical interventions, and lifestyle factors under an Institutional Review Board-approved protocol.  “The scope and sustainability of specimens collected by Fox Chase is as unique as it is impressive, covering nearly every major solid tumor type,” added REPROCELL USA CEO Rama Modali. “REPROCELL's alliance with Fox Chase ensures that the oncology research and development market has access to a premium source of clinically annotated tissue specimens.”

Read the full article at:  http://genengnews.com/gen-news-highlights/reprocell-adding-fox-chase-samples-to-biospecimen-repository/81254194

Apr 01, 2017

REPROCELL Europe Chief Scientific Officer, Stefan Przyborski, publishes new book on 3D Cell Culture Technology

The Chief Scientific Officer of REPROCELL and Durham University Professor Stefan Przyborski is the chief editor of a new book entitled Technology Platforms for 3D Cell Culture; A User’s Guide, recently published by John Wiley & Sons.  The textbook  (ISBN# 978-1-118-85150-0) has 16 Chapters with contributions from over 50 different authors and focuses on leading 3D cell culture technologies for tissue modeling, drug discovery, regenerative medicine and other applications.  Featured in the book is a chapter on Alvetex technology, an artificial scaffold developed in the lab of Prof. Przyborski, and currently sold by REPROCELL in multiple product formats and employed in drug discovery services at the Center for Predictive Drug Discovery in Glasgow, Scotland.

Nov 22, 2016

Healios K.K. contracts with REPROCELL for testing services to support its Regenerative Medicine clinical trials in Japan.

REPROCELL has announced an agreement Healios K.K. (www.healios.co.jp/en) for sample testing to support of human clinical trials conducted by Healios, a biotechnology firm pioneering the development of regenerative medicine approaches in Japan. Healios has initiated clinical trials for the stem cell product MultiStem® developed by Athersys, Inc. for treatment during the acute phase of stroke.  It has been agreed that REPROCELL will be entrusted with some of the testing of patient samples to support these clinical trials.  Healios is also a pioneer for the use of iPS cells and somatic stem cells, in the treatment of age-related macular degeneration (ongoing clinical research). In addition to its iPS cell business, REPROCELL also conducts laboratory testing of human samples for hospital that provide hematopoietic stem cell transplants and organ transplants across Japan. Through this contract business and other activities, REPROCELL intends to support the emerging field of regenerative medicine and drug discovery. REPROCELL products and services include stem cell technologies and contract research activities that contribute to the development of cell therapy and pharmaceutical products in cutting-edge health fields and related industries.

Nov 21, 2016

Licensing agreement for Stemchymal cell therapy technology signed with Steminent Biotherapeutics Inc. (Taiwan).

Based on the terms of this agreement, REPROCELL will gain exclusive rights for the development and commercialization of Stemchymal for treating Spinocerebellar ataxia (“SCA”) in Japan. In addition, REPROCELL will also have the first right of refusal for  other indications.  REPROCELL plans to develop Stemchymal in Japan as a treatment for SCA which is classified as an intractable disease by the Japan Ministry of Health and Labor Welfare. SCA is a progressive neuro-degenerative disease, which develops primarily in the cerebrum, brainstem, and spinal cord, with progressive motor ataxia symptoms that affect walking, swallowing, and breathing.  The disease is ultimately lethal. There are approximately 30,000 patients in Japan, yet currently there is no effective treatment for this disease.  Steminent is a global biopharmaceutical company spun-off from National Yang Ming University Taiwan. The company was granted “New Biopharma Company Status” from the Ministry of Economic Affairs in Taiwan, and has a cell therapy development pipeline that includes both early stage research and multiple late stage clinical programs, including the Phase 2 clinical trials of Stemchymal in Taiwan for the treatment of SCA.

Nov 16, 2016

FANCL Corporation enters into contract with REPROCELL for human iPS cell-derived model cell development

REPROCELL announces the formation of a technology development agreement and entrustment contract with FANCL Corp. (www.fancl.com) for the development of a 3D model system derived from human iPS cells.  FANCL will develop a multi-component cell culture model system derived from human iPS cells in collaboration with REPROCELL and employ the technology to focus on anti-aging drug development. FANCL researches, develops, manufactures, and sells cosmetics and nutritional supplements.  In the future, FANCL plans to use the cell technology to advance its basic research and product development. Human iPS cells hold great promise not only for regenerative medicine, but as a tool for product development applicable to a variety of fields, including cosmetics.  A key strategy of REPROCELL is to apply the accumulated human iPS cell know-how to development innovative tools for use in a variety of medical and other business applications.

Sep 20, 2016

Alvetex wins CV Technology Innovator Awards 2016

ReproCELL is proud to announce its groundbreaking 3D cell culture technology Alvetex has been awarded the Corporate Vision Technology Innovator Award 2016.

Read the full interview with Prof. Dr. Stefan Przyborski, ReproCELL Europe’s Chief Scientific Officer and inventor of Alvetex, here: http://reinnervate.com/reprocell-europe-wins-cv-tech-innovator-awards-2016-alvetex/

Sep 20, 2016

REPROCELL Europe wins the Corporate Vision Technology Innovation Award for Alvetex technology for 3D cell culture

Developed at Durham University by Professor Stefan Przyborski, Alvetex technology, now part of REPROCELL, is available commercially in multiple formats, with numerous protocols and applications for 3D cell culture.  Read the full interview with Professor Stefan Przyborski, who is also the Chief Scientific Officer for REPROCELL Europe.  http://reinnervate.com/reprocell-europe-wins-cv-tech-innovator-awards-2016-alvetex/

May 13, 2016

Biopta and Proteon publish results demonstrating Vonapanitase effects on human cephalic veins

Proteon Therapeutics Announces Publication in Cardiovascular Pharmacology: Open Access Describing Promising Nonclinical Results for Vonapanitase in Improving Arteriovenous Fistula (AVF) Maturation and patency in Chronic Kidney Disease (CKD) Patients.

Proteon Therapeutics Inc. (Nasdaq:PRTO), a longstanding client of Biopta, is developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases. Proteon today announced publication of additional nonclinical data on investigational drug vonapanitase in chronic kidney disease (CKD). The ex vivo study demonstrated that vonapanitase removed elastic fibres from human cephalic veins in a dose-dependent manner, as assessed by both desmosine and histological staining of elastic fibres.

The study, titled "Recombinant Human Elastase Treatment of Cephalic Veins", was published by Proteon's Senior Vice President and Chief Medical Officer, Steven Burke, M.D., with Dr Karen Bingham and Dr Emma Moss of Biopta as co-authors. The full paper can be accessed in Cardiovascular Pharmacology: Open Access.

Nov 25, 2015

REPROCELL to acquire Scottish life science and drug discovery company Biopta

REPROCELL Inc. has announced the acquisition of the Scottish life sciences company, Biopta. The acquisition of Biopta and its US subsidiary, Biopta Inc. is expected to complete on the 10th of December and is aimed at strengthening REPROCELL’s pharmaceutical industry-targeted drug discovery services. The acquisition will also see an immediate investment to expand Biopta’s range of contract research services. Biopta, which will continue to operate from its headquarters in Glasgow, aims to grow its workforce to 30 over the next three years and Biopta’s management views the synergies within the REPROCELL Group of companies as key to its growth ambitions. Dr David Bunton, Biopta’s co-founder and CEO said, “The acquisition by REPROCELL is a great opportunity to build on the solid platform we have in outsourced drug discovery services. Scotland is known for the quality of its scientists and customer service and REPROCELL’s investment recognizes these strengths. We have had a close partnership with BioServe, another REPROCELL Group company, for the past five years, which has helped us establish a very successful US subsidiary. We see the acquisition as the natural next step in the growth of the UK and US businesses.”

REPROCELL, a leader in the field of stem cells and regenerative medicine, was established in 2003 with the goal of contributing to people’s health and welfare through the development of stem cell technologies. Many of REPROCELL’s technologies were developed by the stem cell pioneers, Prof. Norio Nakatsuji from the Institute for Integrated Cell-Material Sciences, Kyoto University, and Prof. Hiromitsu Nakauchi from The Institute of Medical Sciences, The University of Tokyo. REPROCELL’s CEO, Dr Chikafumi Yokoyama said of the acquisition, “This will allow our company to increase our market share by expanding our line-up of drug discovery support products aimed at the pharmaceutical industry and accelerate the development of REPROCELL’s new products and services.”

Industry News

Nov 08, 2017

Japan faces new competition in the race for ‘regenerative medicine’

TOKYO – Promising iPS cell technology could lead to breakthroughs in Parkinson’s disease, blindness and paralysis.   Masaya Nakamura is a professor in the department of orthopedic surgery at Keio University, and a member of an elite group of scientists and doctors working in the field of regenerative medicine.  These researchers believe th lives of patients suffering from Parkinson’s disease, heart failure, blindness, paralysis and other debilitating health problems could be transformed using “induced pluripotent” stem cells or iPS cells.

Read the full article at:  https://asia.nikkei.com/Features/Cover-story/Japan-faces-new-competition-in-the-race-for-regenerative-medicine.

Aug 08, 2017

Daiichi Sankyo latest Japan Pharma to announce Regenerative Medicine plans

TOKYO -- Japanese companies are joining the search for ways to commercialize induced pluripotent stem cells, spurred in part by recent legislation designed to fast-track such forms of regenerative medicine.

One new entrant is Daiichi Sankyo, which announced Monday that it will seek to commercialize sheets of heart muscle tissue derived from iPS cells as a treatment for heart disease. The pharmaceutical company is investing an undisclosed amount in the Osaka University spin-off Cuorips, which developed the sheets of myocardial cells. The idea is to grow the sheets and graft them onto the heart to help it beat properly. This would give patients with severe heart failure an alternative to a transplant or an artificial heart.

Daiichi Sankyo will conduct clinical trials in cooperation with doctors at Osaka University and work to develop a way to mass-produce the sheets of myocardial tissue. This represents the Japanese drugmaker's first foray into the field of iPS cells; it is aiming to gain global marketing rights.

Read the full article at: https://asia.nikkei.com/Business/Trends/Daiichi-Sankyo-latest-in-Japan-to-tap-iPS-cells

Aug 07, 2017

Japan firms to mass-produce blood-clotting treatment from stem cells; set sights on 2020 for approval

TOKYO -- Sixteen Japanese companies will spearhead an effort to develop a way to mass-produce from stem cells a blood component necessary for clotting, aiming to get the green light for its use in 2020.

Platelet cells are administered to surgical patients and accident victims to minimize bleeding. They are currently acquired via donations. Around 800,000 people a year in Japan receive transfusions of platelet cells, making the market worth about 70 billion yen ($630 million). In the U.S., it is more than three times as large.

With a declining and aging population, there are concerns that Japan will no longer be able to meet its platelet needs through donations alone. University-spawned venture Megakaryon will thus work with the Otsuka Pharmaceutical group and Sysmex to begin clinical trials as early as next year of platelet cells derived from induced pluripotent stem cells, or iPS cells.

Platelets derived from stem cells will be significantly cheaper to produce, Megakaryon claims. Donated platelets also have a shelf life of only four days because they cannot be placed in cold storage, compared with two weeks for stem-cell-derived platelets, which are produced in sterile conditions. This will also slash costs.

Reduced risk of infection is another potential plus, given past incidents of donated blood infecting patients with the AIDS and hepatitis C viruses.

Megakaryon already has technology for producing platelets from iPS cells. To establish the mass production technology essential for clinical trials, it will work with 15 other companies, including Otsuka, Nissan Chemical Industries, Sysmex, CMIC Holdings, Satake Chemical Equipment Manufacturing, Kawasumi Laboratories and Kyoto Seisakusho.

Current technology allows enough platelets for one to three people to be produced in the laboratory. This would be scaled up to enough for thousands, requiring specialized knowledge in such areas as filters for eliminating impurities and packaging for blood products.

The plan is to run clinical trials as early as next year and receive timely approval from Japanese authorities to use the platelets for real-world treatment as a regenerative medicine product. Actual production would be commissioned to companies with the necessary facilities.

Read the full article at: https://asia.nikkei.com/Tech-Science/Tech/Japan-firms-to-mass-produce-blood-clotting-treatment-from-stem-cells

Aug 02, 2017

iPS cell drug discovery taking off with first clinical trial

Kyoto team's process to improve safety, speed, success rate of medicine screening

OSAKA -- Using iPS cells to discover drugs faster and more reliably has become a practical reality as a Kyoto University team prepares the world's first clinical trials of a medicine so developed, marking a leap in medical science.

Professor Junya Toguchida has found a candidate drug for treating fibrodysplasia ossificans progressiva, or FOP -- a condition in which bone can grow in muscle tissue and elsewhere -- using induced pluripotent stem cells, the university's Center for iPS Cell Research and Application said Tuesday. Clinical trials are to start in September at the earliest. There is no effective remedy yet for the rare condition, from which around 80 Japanese are said to suffer.

A Kyoto University Hospital review committee has given the go-ahead for the trial, and the university has given notice to the Pharmaceuticals and Medical Devices Agency. Once all the necessary approvals are granted, safety and effectiveness trials can commence on a total of 20 test patients, aged 6 to 59. Plans call for the trials to be conducted at the University of Tokyo, Nagoya University and Kyushu University as well.

Read the full article at: https://asia.nikkei.com/Tech-Science/Science/iPS-cell-drug-discovery-taking-off-with-first-clinical-trial

Jun 08, 2017

Battling Asia's liver cancer scourge

HONG KONG -- Asia is the world leader in liver cancer -- 80% of global cases occur in the continent, with 55% of new diagnoses appearing in China and Hong Kong alone. The disease is the most prevalent form of cancer in Laos, Mongolia, Taiwan and Thailand.  "It's a huge problem in this part of the world," said Irene Ng, professor of pathology at the University of Hong Kong and a leading liver cancer expert. Fortunately, however, Asia is also a hotspot of research into the disease -- in part through Ng's own work.

The explanation for Asia's vulnerability to liver cancer is simple: Asian countries tend to have high rates of hepatitis B, a viral disease that causes inflammation of the liver. Carriers are 100 times more likely to develop liver cancer than non-carriers, while pregnant women can pass the virus to their babies during birth.

Infected infants develop a chronic, incurable infection that in later years causes cirrhosis of the liver, an irreversible condition in which damaged cells are replaced by hard scar tissue. Hepatitis C, caused by a different virus, is less prevalent, but also causes the cirrhosis that makes sufferers susceptible to cancer.

Liver cancer is extremely aggressive, often killing patients just a few weeks after diagnosis. It can be treated by surgery, but according to Ng "only a quarter" of patients are suitable. "The liver has two lobes, left and right. If the cancer is confined to one lobe, we can remove it," she said. "But if it has already spread to both, it's too late."

Recurrence rates are high. "If we don't remove every single cancer cell the first time, then it comes back, usually within two years," Ng told the Nikkei Asian Review.

Chemotherapy is commonly used, but is often unsuccessful and exacts a terrible toll in terms of side effects.  In the future, cases of liver cancer will likely drop as hepatitis B vaccination programs are introduced across the region. Right now, though, new and effective treatments are vitally needed, and Ng is one of a number of scientists pioneering the development of novel therapies.  She investigates the disease's underlying pathology, focusing on the cancer stem cells that make liver cancer such a hard-to-combat disease. "Cancer stem cells are small in number but they're extremely powerful," she said. "If the cancer is an army, the regular tumor cells are the foot soldiers and the stem cells are the officers in charge."

The cancer stem cells drive the growth and spread of cancer through the liver, and into other parts of the body via metastasis -- the development of secondary malignant growths at a distance from the primary site of cancer. They also endow tumors with their formidable resistance to chemotherapy.

Read the full article at: https://asia.nikkei.com/Tech-Science/Science/Battling-Asia-s-liver-cancer-scourge

Mar 10, 2017

Japan kicking regenerative medicine development into high gear

OSAKA -- Three academic and business groups in Japan are planning to conduct clinical studies on donated stem cells in the fiscal year starting next month, aiming to commercialize such regenerative therapy. So far, only one clinical study has looked at creating tissue from induced pluripotent stem cells. The cells could be harvested from donors and grown into skin and other body parts that would replace damaged tissue.

The method promises to be less costly. A bank of donated cells would also eliminate the time needed to grow tissues using the patient's own stem cells.

 

The three groups announced their research plans at a recent gathering held in Sendai, a city north of Tokyo, by the Japanese Society for Regenerative Medicine. Japan Tissue Engineering, a Fujifilm Holdings subsidiary, is joining Kyoto University to heal victims of severe burns with grown skin grafts. The partners are mulling either physician-led clinical trials or preliminary clinical research. Kyoto University Hospital will certify the results.

Tissue reconstruction is expected to start in about a week depending on the substance exuded by the transplanted skin cells. The procedure is said to cost between 1 million yen and 2 million yen ($8,700 and $17,400) -- less than a quarter what's required for conventional methods. Apart from Japan, operations in Southeast Asia and other places are also on the table.

Rohto Pharmaceutical and a team at Niigata University led by Shuji Terai aim to cure liver cirrhosis through stem cells harvested from fatty tissues during surgeries. Substances excreted by the implanted stem cells will spur the regeneration of damaged liver tissue. The group will submit applications for clinical trials to the Japanese government and elsewhere by this summer.

A team led by associate professor Takanori Iwata at Tokyo Women's Medical University looks to repair the base of teeth lost to severe periodontal disease. For the clinical trial being planned, donor stem cells mainly from wisdom teeth will be implanted into patients.

Read the full article at: https://asia.nikkei.com/print/article/244715

OSAKA -- Three academic and business groups in Japan are planning to conduct clinical studies on donated stem cells in the fiscal year starting next month, aiming to commercialize such regenerative therapy. So far, only one clinical study has looked at creating tissue from induced pluripotent stem cells. The cells could be harvested from donors and grown into skin and other body parts that would replace damaged tissue.

The method promises to be less costly. A bank of donated cells would also eliminate the time needed to grow tissues using the patient's own stem cells.

 

The three groups announced their research plans at a recent gathering held in Sendai, a city north of Tokyo, by the Japanese Society for Regenerative Medicine. Japan Tissue Engineering, a Fujifilm Holdings subsidiary, is joining Kyoto University to heal victims of severe burns with grown skin grafts. The partners are mulling either physician-led clinical trials or preliminary clinical research. Kyoto University Hospital will certify the results.

 

Tissue reconstruction is expected to start in about a week depending on the substance exuded by the transplanted skin cells. The procedure is said to cost between 1 million yen and 2 million yen ($8,700 and $17,400) -- less than a quarter what's required for conventional methods. Apart from Japan, operations in Southeast Asia and other places are also on the table.

 

Rohto Pharmaceutical and a team at Niigata University led by Shuji Terai aim to cure liver cirrhosis through stem cells harvested from fatty tissues during surgeries. Substances excreted by the implanted stem cells will spur the regeneration of damaged liver tissue. The group will submit applications for clinical trials to the Japanese government and elsewhere by this summer.

 

A team led by associate professor Takanori Iwata at Tokyo Women's Medical University looks to repair the base of teeth lost to severe periodontal disease. For the clinical trial being planned, donor stem cells mainly from wisdom teeth will be implanted into patients.

 

Read the full article at: https://asia.nikkei.com/print/article/244715

Upcoming Events

Sep 19, 2018
Sept.19-21, 2018

REPROCELL will attend the 6th annual Cambridge University stem cell symosium.  Come by and visit our booth and meet our technical and commercial staff to learn more about our cutting edge stem cell services and products, including the StemRNA 3rd Gen Reprogramming technology for clinically relevent iPSCs.

Jun 20, 2018
June 20-23, 2018 / Melbourne, Australia

Every year, REPROCELL participates in the ISSCR conference.  Come by and see us in the exhibit hall to learn more about our Stem Cell Services and leading products for basic research and translational medicine.

Jun 18, 2018
June 18-21, 2018 / Boston, USA

The REPROCELL team will be at the World Preclinical Congress exhibition in Boston, this summer.  Representatives from our drug discovery and stem cell service labs will be on-hand to tell you how REPROCELL can save you time & money and de-risk your drug development and iPSC preparations. 

Apr 15, 2018
April 15-18, 2018 / Chicago, USA

REPROCELL will again be attending the AACR Annual Conference this year.  Please come by and visit our booth (#4331), at the McCormick Convention Center in Chicago.  REPROCELL has human tissue resources that includes an extensive collection of cancer biospecimens and Molecular Services to speed up your research.

Mar 21, 2018
March 21-23, 2018 / Yokohama Pacifico Convention Center

REPROCELL will have an exhibition booth at the JSRM conference.  Both business units (REPROCELL Discovery and REPROCELL Medical) will be represented to promote technologies and ongoing clinical efforts to support Regenerative Medicine.

Feb 21, 2018

REPROCELL’s Prof Stefan Przyborski will chair the SMi 2nd Annual Conference on 3D Cell Culture – London UK, 21-22 February 2018. The venue is the Copthorne Tara Hotel in Kensington, London, UK.

Stefan Przyborski is Professor of Cell Technology at Durham University’s Department of Biosciences and Chief Scientific Officer of REPROCELL Europe Ltd.

More information can be found on our blog:

https://blog.reprocell.com/prof-stefan-przyborski-to-chair-smi-conference-on-3d-cell-culture-london