BioInformant

Your Global Leader in Stem Cell Market Research

Home » Stem Cell News » Press Releases » Page 45

Stemedica Receives Approval from Emory University to Initiate Alzheimer’s Disease Study with Adult Allogeneic Stem Cells

By

Lausanne, Switzerland; February 24, 2016 — Stemedica International, SA, a Stemedica Cell Technologies, Inc., a subsidiary and leader in the development of innovative stem cell-based treatments for Alzheimer’s Disease announced today that it has received IRB approval from Emory University in Atlanta, Georgia to initiate a clinical study entitled, “A Phase IIa Multicenter, Randomized, Single-Blind, Placebo-Controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease.”

This study will enroll approximately 40 subjects diagnosed with mild to moderate dementia at least three months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer’s criteria.

“We are very excited to take this next step in our clinical plan to develop a treatment for this devastating disease,” says Nikolai Tankovich, M.D., Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies and Executive Chairman for Stemedica International “Patients will be treated at Emory and additional trial sites to be announced.”

About Stemedica International S.A.

Stemedica International S.A. is a biotechnology company that develops therapeutic applications for the treatment and prevention of Alzheimer’s disease and vascular dementia. The company is a subsidiary of Stemedica Cell Technologies, Inc., a global biotechnology company that manufactures adult allogeneic stem cells. Stemedica International has the worldwide rights to manufacture and distribute the parent company’s allogeneic, ischemia-tolerant mesenchymal stem cell (itMSC) and ischemia-tolerant neural stem cell (itNSC) lines and stem cell factors for Alzheimer’s disease and vascular dementia indications. The company also has Swissmedic licenses to import, export and distribute Stemedica Cell Technologies’ cell lines worldwide for human use in approved clinical trials. Manufactured in compliance with cGMP standards, the stem cell lines have a unique, proprietary technology based on the expansion of cells in constant hypoxia, which provides critical benefits in terms of safety, efficacy and scalability. For more information, visit www.stemedica-intl.com.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a specialty biopharmaceutical company that manufactures best-in-class, allogeneic, adult stem cells and stem cell-derived factors. The company is a government-licensed manufacturer of cGMP, clinical-grade stem cells currently used in clinical trials in the United States under FDA Investigational New Drug (IND) approval for chronic heart failure, cutaneous photoaging, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used by research institutions and hospitals outside of US under the auspices of international regulatory authorities for pre-clinical and clinical (human) trials. Stemedica is developing clinical trials for other indications using its adult, allogeneic stem cells. The company has headquarters in San Diego, California, and can be found online at www.stemedica.com.

Forward Looking Statements

This press release may contain forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance and you are cautioned not to place undue reliance on these forward-looking statements. These statements reflect the views of Stemedica as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward looking statements, whether as a result of new information, future events or otherwise after the date of this press release.

Media and Business Contact
David Cheatham
Stemedica International S.A.
+41 (0)78 794 7232
[email protected]

Want to be better informed than your competition? Get future stem cell industry updates.

 

About Us

BioInformant is the first and only market research firm to specialize exclusively in the stem cell industry. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, and Becton Dickinson, BioInformant is your global leader in stem cell industry data.

Click here to view our global strategic reports for the stem cell and cord blood industry.

Cesca Therapeutics Acquires $15M Strategic Investment From Chinese Cloning Giant, Boyalife Group

By

Cesca TherapeuticsOn February 3, 2016, Cesca Therapeutics (NASDAQ:KOOL) released news that Boyalife Group was making a $15 million strategic investment in the company.

Stock priced jumped following the news, although it has since been volatile.

Located in Rancho Cordova, California, Cesca Therapeutics specializes in the research, development, and commercialization of autologous cell-based therapeutics for regenerative medicine applications. With the stem cell and cord blood marketplace, the company is best known for it automated blood and bone marrow processing systems, such as the AutoXpress® Platform (AXP®), the MarrowXpress® Platform, the BioArchive® System, and others.

On the other hand, Boyalife Group is best known for its cloning technologies, although it describes itself as involved with “stem cell technologies, regenerative medicine, genomics and cloning, cancer immune therapies, disease mechanistic studies and innovative drug discovery.”

As stated in the press release:

“Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that affiliates of Boyalife Group have agreed to invest $15.0 million in the Company (the “Boyalife Financing”), enabling the Company to repay currently outstanding senior secured convertible debentures and retire associated Series B Warrants. The investments will also provide additional working capital to fund the Company’s ongoing operations and strategic initiatives.”

Additionally, Dr. Xiaochun Xu, Chairman and CEO of Boyalife Group commented:

“This investment lays the foundation for what we see as a strong and continuing strategic alliance between our two companies. Beyond Cesca’s existing pipeline of autologous cell-based therapies, this partnership has the potential to enable access to a much broader scope of clinical applications as well as accelerate penetration of the 1.3 billion person market in China.”

To learn more, visit www.CescaTherapeutics.com.

About BioInformant

BioInformant is the only research firm to serve the stem cell sector since it emerged. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, and Becton Dickinson, BioInformant is your global leader in stem cell industry data.

Click here to view our global strategic reports for the stem cell industry.

Human Longevity, Inc. to Expand Reach into Neonatal & Maternal Health Markets by Acquiring Celgene Owned LifebankUSA

By

In major news released today, Human Longevity, Inc. (HLI) announced that is is acquiring LifebankUSA, a cord blood, placental blood, and tissue bank owned by Celgene Cellular Therapeutics.

Based in San Diego, CA, Human Longevity, Inc. is an innovative company that specializes in the use of whole genome sequence analysis, clinical imaging, and machine learning to extend health across a longer human lifespan. LifebankUSA, based in Cedar Knolls, NJ, is the “the only company that offers cord blood, placenta blood and tissue banking – and the first to release placenta-derived stem cells for a successful transplant.” Celgene Cellular Therapeutics (CCT), the parent company of LifeBankUSA, specializes in cell therapy and regenerative medicine products, using LifeBankUSA to source its cell therapy, organ and tissue products, several of which are now being explored in clinical trials (PDA001, PDA002, and others).

The move will position Human Longevity, Inc. to offers its newborn genome sequencing product in combination to its newly acquired stem cell banking services.
 [Read more…]

Sernova Announces Agreement with CCRM to Produce Specialized Cells for the Treatment of Diabetes

By

Today, Sernova announced the exciting news that CCRM will be manufacturing its stem cell technology for diabetes, a disease which affects over 40 million patients. CCRM are experts in the stem cell manufacturing field and will be Sernova’s cell manufacturing arm.

Previously, in September 2015, Sernova announced it had signed a license agreement with the University Health Network (UHN) located in Toronto, Canada, for exclusive worldwide rights to specific technologies developed by two UHN researchers, Dr. Cristina Nostro and Dr. Gordon Keller. This cell manufacturing agreement executes Sernova’s worldwide exclusive license agreement to the Nostro/Keller technology and puts Sernova center stage within the diabetes space, where the company is actively working to secure large pharma partners.

This program is advancing in parallel to Sernova’s hemophilia program with multibillion dollar potential, in which a consortium of academic development partners and full non-dilutive funding ($8.5M Cdn) has been secured through the European Union’s Horizon 2020 grant mechanism. [Read more…]

Coriell Institute Further Invests in iPSC Infrastructure by Licensing PluriTest(R) Stem Cell Technology

By

In the past couple years, the Coriell Institute, in Camden, New Jersey, has emerged as a leader in the area of induced pluripotent stem cells (iPSCs). In a landmark event in March 2013, Cellular Dynamics International (CDI) and the Coriell Institute for Medical Research announced receipt of multi-million dollar grants from the California Institute for Regenerative Medicine (CIRM) for the creation of iPSC lines from 3,000 healthy and diseased donors.

CIRM awarded CDI $16 million to create three iPSC lines for each of 3,000 healthy and diseased donors and awarded the Coriell Institute $10 million to set up and biobank the iPSC lines. The result will be the creation of the world’s largest human iPSC bank, an incredible feat.

In news released today, January 20, 2016, Coriell Institute announced that it will further continue its investment into iPSC infrastructure by in-licensing PluriTest® technology from stem cell pioneers Dr. Jeanne Loring and Dr. Franz Josef Muller.

To learn more, read the full press release, published below with permission from Coriell Institute.

Coriell Institute Licenses PluriTest(R), a Novel Stem Cell Technology

PRESS RELEASE; Wednesday, January 20, 2016; CAMDEN, N.J. – The Coriell Institute for Medical Research today announces the in-licensing of PluriTest, a cost-effective, accurate, animal-free bioinformatics assay for determining the pluripotency of human induced pluripotent stem cells (hiPSC).

Developed by Dr. Jeanne Loring, now at the Scripps Research Institute, and Dr. Franz Josef Muller, now at the University of Kiel, PluriTest leverages microarray technology to identify genes active in normal human embryonic and induced pluripotent stem cells and non-pluripotent cells in order to generate a detailed molecular model of a normal pluripotent stem cell line. Using this comprehensive molecular model, PluriTest delivers superior standards of cell line quality control and characterization.

“We saw a need for a method to characterize human pluripotent stem cells that was inexpensive and easy to use, without compromising the rigorous quality researchers require of their materials,” says Dr. Loring, who has offered PluriTest online since publication of the assay in 2011*. More than 13,000 datasets have been analyzed since the assay was made available online.

Designed to assess whether a cell is capable of diverse differentiation, PluriTest is more efficient than the conventional method, the teratoma assay, while also serving as an animal-free testing alternative.

“This is a field of interest that has been marked by a tremendous amount of growth and progress in a relatively short span of time,” says Dr. Michael Christman, president and CEO of Coriell Institute. “As scientists increasingly rely on these powerful assets to drive disease studies, it’s imperative that hiPSC lines are of a high and consistent grade. Partnering with Drs. Loring and Müller and facilitating access to this innovative assay ensures those benchmarks of quality are met.”

Currently managed through a user-friendly digital interface backed by the Amazon Cloud, Coriell and the inventors intend to collaborate and develop future releases of PluriTest with additional functionality and service packages.

“We aspire to help accelerate work in the lab setting, and aligning with an expert organization like Coriell is key to that aim,” says Dr. Loring.

Integrating PluriTest as a standard component of a first-class hiPSC program is an extension of the Institute’s deep understanding of the need for high standards in biomaterials. The adoption of innovative techniques and technology enables Coriell to advance the research community’s utility of hiPSCs.

In late 2015, Coriell – in partnership with the California Institute for Regenerative Medicine – launched a repository of hiPSCs representing eleven common diseases, such as autism, Alzheimer’s disease, and heart, lung and liver diseases. The hiPSC collection is positioned to reach 750 lines by February and will accommodate 3,000 lines over the next several years, qualifying Coriell’s hiPSC collection as the world’s largest.

For more information about the PluriTest service, including how to access, contact [email protected].

*Muller, F. J. et al. A bioinformatic assay for pluripotency in human cells. Nature methods 8, 315-317, doi:10.1038/nmeth.1580 (2011).

About Coriell Institute

Coriell Institute for Medical Research is a pioneer in genomics, examining the utility of genetic information in clinical care through the Coriell Personalized Medicine Collaborative (CPMC) research study (cpmc.coriell.org). Coriell is also unlocking the promise of induced pluripotent stem cells and their role in disease research and drug discovery. Additionally, the Institute continues to be recognized as the world’s leading biobank, distributing biological samples and offering research and biobanking services to scientists around the globe. For more information, visit www.coriell.org and catalog.coriell.org or follow @Coriell_Science on Twitter.

CONTACT:
Matthew Chimento
Associate Manager, Communications
[email protected]
(856) 757-9710

Want to be better informed than your competition? Get future stem cell industry updates.

 

About Us

BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of market research. BioInformant research has been cited by major news outlets that include the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, and Becton Dickinson, BioInformant is your global leader in stem cell industry data.

Click here to view our global strategic reports for the stem cell and cord blood industry.

BioInformant's World-Class Clients