The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]
As a provider of stem cell products and technologies, you know you need to:
- Make effective product development decisions
- Sell more effectively
- Generate improved revenues
- Take market share
Without strategic guidance on which to base your actions, you’re in a difficult position. New products that don’t sell well are costly mistakes. On the other hand, repeatedly launching high-demand products and skillfully addressing the unmet needs of your clients is certain to position you as a market leader.
Boston biotech company ORIG3N has announced a collaboration with South Korea’s Kangstem Biotech in a joint effort to gain insight on the effectiveness of induced neural stem cells (iNSC) in disease modeling. As a pioneer of regenerative medicine, ORIG3N is leading the way towards the future of medicine by crowdsourcing blood samples to create the world’s largest and most diverse biorepository of stem cells.
As part of this collaboration, Kangstem Biotech will be providing iNSC’s to ORIG3N for research. This partnership between a pioneer in the biotechnology industry and one of the largest global biopharmaceutical companies is an exciting development in regenerative medicine. [Read more…]
Final Results for the First Six Patients to be Released Later this Quarter
NEWARK, Calif., April 18, 2016 (GLOBE NEWSWIRE) — StemCells, Inc. (NASDAQ:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of central nervous system disorders, announced today that Dr. Stephen Huhn, the Company’s Chief Medical Officer and VP of Clinical Research, presented additional details on its ongoing Phase II Pathway™ Study of HuCNS-SC cells for the treatment of chronic cervical spinal cord injuries. The presentation, which took place at the 2016 American Spinal Injury Association (ASIA) annual meeting in Philadelphia on Friday, April 15, included a top line update for the six patients enrolled in open label Cohort I from the Pathway Study. The 6-month results from Cohort I showed that muscle strength had improved in five of the six patients with four of these five patients also demonstrating improved performance on functional tasks assessing dexterity and fine motor skills. In addition, four of the six patients had improvement in the level of cord injury as measured by ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) assessment. The Company expects to release detailed final 12-month results on this first open-label cohort later this quarter.
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 public hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations for the events and 100 people and groups interested in presenting, it was clear that individuals across the United States are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S. The event has since been rescheduled as a two-day public hearing to be held over September 12-13, 2016, in a larger venue, Masur Auditorium, at the NIH campus in Bethesda, MD. [Read more…]