This was a major week in the stem cell sector, with significant announcements released by STEMCELL Technologies, Accellta, Cellect Biomed, CardioCell, and more. The FDA also released significant news pertaining to a public hearing that will address the regulation of stem cells within the United States.
Check it out and let us know what you think!
STEMCELL Technologies announced that it has partnered with the Institute of Molecular Biotechnology (IMBA) in Vienna, Austria, to develop products for cerebral organoid culture. Founded in 1993 and headquartered in Vancouver, STEMCELL Technologies is a diversified provider of stem cell research products. The company is known for utilizing strategic alliances to grow its dominance within the stem cell field, with current partnerships including licensing deals with the Wisconsin Alumni Research Foundation (WARF), iPS Academia Japan Inc., Salk Institute for Biological Sciences, and more.
Cellect Biomed Ltd. and Accellta announced that they have signed an agreement to evaluate Cellect’s apoptotic induction based technology in combination with Accellta’s stem cell culturing technologies. Cellect Biomed Ltd. is headquartered in Tel Aviv, while Accellta is headquartered in Haifa, Israel. Accellta can quickly, efficiently, and cost-effectively grow massive quantities of clinical grade cells in xeno-free, feeder-free culture, by utilizing methods of growing the cells in suspension. Cellect has a unique technology that can functionally select stem cells based on their sensitivity to apoptosis.
Dr. Askenase is an expert in the effector properties of exosomes who is now beginning to study mesenchymal stem cell (MSC)-derived exosomes and their role in regenerative processes. Dr. Askenase’s new unpublished preliminary work is focused on the role of MSC-derived exosomes in healing the injured spinal cord in rats. In this interview, we discuss the growing importance of MSC-derived exosomes, including their advantages and applications, the market potential for exosomes, and companies competing in this emerging market area.
CardioCell, LLC, annnounced that it had completed enrollment for its Phase IIa chronic heart failure (HF) clinical trial. The Phase IIa study protocol delivers ischemia-tolerant mesenchymal stem cells (itMSCs) via intravenous infusion to participants with non-ischemic cardiomyopathy. CardioCell’s itMSCs are exclusively licensed from its parent company, Stemedica.
The stem cell market has grown increasingly complex over the past few years, especially in the regulatory space. The NIH recently had an overwhelming response for participation in its Part 15 hearing to review draft guidances controlling the regulation of stem cells. The Office of U.S. Senator for Illinois, Mark Kirk, also introduced the REGROW Act in March 2016, which has been exceedingly controversial. Regulation of the stem cell market is at a tipping point, but which direction it will fall?
After the FDA received more than 600 registrations for its Part 15 Hearing to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products,” it cancelled the originally scheduled event. The FDA announced the rescheduled hearing will occur over September 12-13, 2016, at Masur Auditorium on the NIH campus. Two-day format is a substantial improvement over the original one-day format, as is the larger venue size.
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