The stem cell sector is fueled by innovation and rapid change. To keep you up-to-date, we recently released new coverage of the industry. Check it out and let us know what you think!
The FDA public hearing to review four draft guidances controlling the regulation of stem cells originally scheduled for April 13, 2016, was cancelled due to a massive registration response. With 600 event registrations, 100 speaker requests, and only 3 minutes allocated per presenter, it was extremely clear that the event needed reformatting. It is my opinion – and one shared by most advocacy groups – that the large turn-out for the event was a successful effort to communicate patient concerns to the FDA and a way to indicate that more input is needed in the regulatory process.
To date, there have been major roadblocks that have impeded the therapeutic use of MSCs, including donor-to-donor variability and the “sky-high” costs of manufacturing products that rely upon multiple stem cell donors. Cynata Therapeutics has announced a revolutionary approach to MSC manufacturing that utilizes induced pluripotent stem cells (iPSCs) as the starting material. The company’s breakthrough is multi-faceted: it can produce MSCs in unlimited quantities, in uniform batches, from a single donor, and at low cost. Cynata is positioned to be the first company to use iPSC-derived MSCs within human patients.
This popular guest article by RoosterBio explores four major misconceptions about mesenchymal stem cells (MSCs) that have persisted over the years, despite widely-accepted paradigm shifts on MSC nature and function. These misconceptions include: 1) MSCs isolated from different tissues are equivalent; 2) MSCs are defined by their surface isotopes; 3) Cloning MSCs provides homogeneous preparations of cells; and 4) Properties of MSCs in culture reflect their properties in vivo.
VetiCell, LLC, has announced that it is launching a proactive stem cell storage program for animals, in which it will collect stem cells from the umbilical cord of horses or from the reproductive tissues of dogs following spay or neuter. VetiCell is a sister company to AlphaCord, a human cord blood bank, with the two companies having the same owner and staff. With hundreds of human cord blood banks now competing worldwide, it will be interesting to see whether any of them add equine cord blood banking to their portfolio of human stem cell storage services.
The Office of the U.S. Senator for Illinois, Mark Kirk, has announced the introduction of The REGROW Act, a bill designed to “reduce barriers to medical innovation and accelerate the development of new regenerative medicine treatments.” The legislation would require the FDA to “collaborate with stakeholders to develop standards that will lead to manufacturing processes and controls for safe regenerative medicine products.”
Since the discovery of iPSCs, a large and thriving research product market has grown into existence. Recent years have seen major advances in clinical research applications, production and differentiation technologies, and biobanking of iPSCs. Today, the number of iPSC products sold worldwide is increasing with double-digit growth and 22% of stem cell researchers self-report having used iPSCs within a research project. A distinctive feature of this report is an end-user survey of 273 researchers (131 U.S. / 143 International) that identify as having induced pluripotent stem cells as a research focus.