Your Global Leader in Stem Cell Market Research
Passed December 13, 2016, the 21st Century Cures Act authorizes $6.3 billion in funding. It will support the development of innovative regenerative medicines, by providing substantial funding to the U.S. NIH and the FDA, among other groups.
In this article:
MELBOURNE, Australia, Feb. 27, 2018 — Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX:CYP) is pleased to announce that the Primary Evaluation Period has been completed for the first cohort of patients in the clinical trial of its lead Cymerus™ mesenchymal stem cell (MSC) product CYP-001, for the treatment of steroid-resistant graft versus host disease (GvHD). [Read more…]
January 29, 2018 – Nikon Corporation (Kazuo Ushida, President, Tokyo) has announced a business alliance agreement (hereinafter referred to as the “agreement”) with Advanced Cell Technology and Engineering Ltd. (Koichi Otomo, President, Tokyo, hereinafter referred to as “ACTE”) in order to establish a clinical-use master cell bank (MCB)*1, to be employed for regenerative medicine products derived from dental pulp cells*2. [Read more…]
Hamburg/Juelich, January 22, 2018 – The second international Stem Cell Community Day will take place on April 24, 2018 in Duesseldorf, Germany. The event brings together experts from industry and academia to discuss recent trends, achievements, and challenges in bioprocessing technologies for stem cell research. The conference is organized by leading life science company Eppendorf AG.
In three sessions, the participants will discuss ways for establishing robust stem cell culture protocols, process strategies for obtaining commercial cell quantities, and challenges related to product purity. Professor Joaquim M. S. Cabral from the University of Lisbon will chair the conference. Dr. Robert Zweigerdt from Hannover Medical School and Karen Coopman, PhD from Loughborough University will present their latest findings in keynote lectures.
“During the first Stem Cell Community Day in 2017 our speakers presented cutting-edge research and we greatly enjoyed the first-hand insights and lively discussions,” reviews Dr. Karl Rix, Head of Business Unit Bioprocess at Eppendorf. “The enormously positive feedback from the participants motivated us to go to the next round.”
All participants are invited to present their work during the poster session. A scientific committee will award three poster prizes. Abstract submission is open until March 19, 2018. To submit an abstract and to register please visit www.stemcellday.de. On the same website, interested persons find information on the program and the venue, as well as impressions of the first Stem Cell Community Day in 2017. The conference language is English. [Read more…]
In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER).
According to the FDA, the Center for Biologics Evaluation and Research (CBER) regulates:
CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.
In the U.S., human tissues intended for transplantation are regulated by the FDA as “Human cells, tissues and cellular and tissue-based products” or “HCT/Ps.” Under U.S. law, any company that engages in the collection, processing, storage, screening/testing, packaging, or distribution of HCT/Ps must register with the FDA.
