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Japan’s Laws Supporting Accelerated Pathways for Cell Therapies

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In late 2014, Japan passed two new laws that revolutionized the commercialization of cell therapies within the country by providing an accelerated pathway for product approvals. While there has been much discussion about these laws, few people have a clear understanding of the implications of these regulations on a global scale.

Below, we summarize the laws, identify their importance, and most importantly, speak to how Japan has become a “gateway country” for regenerative medicines. [Read more…]

RoosterBio Launches New cGMP Stem Cell Product Portfolio

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RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry

Next Generation Products are Harbinger of Paradigm Shift in the Adult Stem Cell Industry

RoosterBioFrederick, MD, USA. September 14, 2017 – RoosterBio Inc, today, proudly announces the launch of its CliniControl™ (CC) product portfolio, clinically-relevant starting and ancillary materials that generate unprecedented efficiencies in adult stem cell manufacturing, accelerating clinical translation of human Mesenchymal Stem/Stromal Cell (hMSC)-based therapies.  The CliniControl product portfolio will radically simplify major steps in product development and clinical translation, improving the likelihood of commercial success for RoosterBio customers.

The first in the CliniControl line of products, RoosterNourish™-MSC-CC bioprocess medium sets the new standard of industry-leading performance.  RoosterNourish-MSC-CC is a first-in-class, standardized, xeno-free (XF) bioprocess medium engineered to support not only 2D (plastic adherent), but also 3D suspension culture of hMSCs in allogeneic and autologous therapeutic manufacturing.  Formulated specifically for clinical research process and product developers, RoosterNourish-MSC-CC yields superior media productivity, leading to drastically reduced cost of goods as compared to other hMSC culture media.   The highly productive RoosterNourish medium is designed for batch 2D and fed-batch 3D cultures and seamlessly translates between culture platforms enabling scalable hMSC culture,  delivering robust, reproducible and standardized results at a commercially-viable cost of goods.  [Read more…]

Celltex Therapeutics | Interview with CEO David Eller

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David Eller CelltexCelltex Therapeutics is a regenerative medicine company that specializes in banking autologous mesenchymal stem cells (MSCs) for therapeutic use. In the Celltex procedure, a small fat sample is taken, from which MSCs are extracted, isolated, multiplied and stored for future use. Patients can then use these autologous (“self-derived”) stem cells for regenerative purposes through infusions or injections performed by a licensed physician.

In this article: 

U.S. DOD to Conduct Studies of Pluristem’s PLX-R18 in a New ARS Project for Use Before Radiation Exposure

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• The DOD studies seek to test the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to and within 24 hours of exposure to high levels of radiation
• The DOD studies will be conducted in parallel with the ongoing ARS project with the NIH

Pluristem TherapeuticsHAIFA, ISRAEL, August 16, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a pilot study of the company’s PLX-R18 cell therapy will be initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation.  [Read more…]

Dr. Vincent Burton Named President of Okyanos Center for Regenerative Medicine

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Changes in Ownership and Management Structure of Grand Bahama-Based Adult Stem Cell and Regenerative Medicine Center Signal Expansion and Growth

FREEPORT, GRAND BAHAMA, JULY 26, 2017 — Vincent R. Burton, MBBS, FRCA, has been appointed President of Okyanos Center for Regenerative Medicine, which is licensed by the Bahamas’ National Stem Cell Ethics Committee (NSCEC).

Dr. Burton received his Bachelor of Medicine, Bachelor of Surgery degree (MBBS) from the University of the West Indies. He went on to complete residency training in the United Kingdom at Queen’s Hospital of Staffordshire, Norfolk and Norwich University Hospital as well as Cambridge University’s Addenbrooke’s Hospital. He is a Fellow of the Royal College of Anaesthetists (FRCA) and has served as Chief Anesthesiologist at Okyanos since the center opened in 2014. [Read more…]

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