Read highlights from the latest instalment of Dusko Ilic’s industry updates, which discuss the latest developments and news in regenerative medicine and stem cell research, and are published every month in Regenerative Medicine.
Every month, Dusko comments on news of note. Read the full update for February 2019 on Regenerative Medicine here>>
1. What happened this month that you were expecting?
US FDA issuing the final versions of two guidance documents regarding regenerative medicine therapies. Both documents were first issued in draft in November 2017 as part of a suite of guidance that comprised the FDA’s comprehensive regenerative medicine policy framework.
2. What happened that surprised you this month?
The US FDA has allowed Investigational New Drug (IND) application for FT516, the Fate Therapeutics’ off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel CD16 Fc receptor. FT516 is the first-ever cell therapy derived from a genetically engineered pluripotent stem cell cleared for clinical testing in the world.
3. If we only read about one story this month, what should it be?
The statement from the US FDA voicing concerns about infusions of blood from young donors to ward off the afflictions of ageing or ageing-associated diseases including dementia, Parkinson’s, Alzheimer’s, heart disease or multiple sclerosis and warning potential users and general public to not buy into the hype.
Dusko Ilic is a Senior Lecturer in stem cell science, coordinator of the cross-divisional postgraduate program in stem cells and regenerative medicine, and Head of the Induced Pluripotent Stem Cell Core Facility at King’s College London (London, UK). He is also Head of the Assisted Conception Unit’s Human Embryonic Laboratories at Guy’s Hospital (London, UK). He is also a member of the editorial board of the journal Regenerative Medicine, where he writes the Industry Report, a regular feature compiling information from non-academic institutions in the field of stem cells and regenerative medicine.