Since the discovery of induced pluripotent stem cell (iPSC) technology 15 years ago, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated.
iPSCs can be used to explore the causes of disease onset and progression, create and test new drugs and therapies, and potentially, treat previously incurable diseases. The somatic cells used for reprogramming include skin cells and blood cells, and to a lesser degree, other cell types such hair follicles, cord blood and urine.
2013 was a landmark year because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Dr. Masayo Takahashi, it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration.
In another world first, Cynata Therapeutics received approval in 2016 to launch the first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. CYP-001 is a iPSC-derived MSC product. In this historic trial, CYP-001 met its clinical endpoints and produced positive safety and efficacy data for the treatment of steroid-resistant acute GvHD.
Given this early success, Cynata is advancing its iPSC-derived MSCs into Phase 2 trials for the severe complications associated with COVID-19, as well as GvHD and critical limb ischemia (CLI). It is also undertaking an impressive Phase 3 trial that will utilize Cynata’s iPSC-derived MSC product, CYP-004, in 440 patients with osteoarthritis (OA). This trial represents the world’s first Phase 3 clinical trial involving an iPSC-derived cell therapeutic product and the largest one ever completed.
iPS Cell Market Competitors: https://www.giiresearch.com/report/biof1053967-global-induced-pluripotent-stem-cell-ipsc-industry.html