Industry Update: Regulations, approvals, acquisitions

Written by Dusko ILIC

Latest regulations, approvals and acquisition developments compiled from 01 — 30 June 2016

Latest regulations, approvals and acquisitions in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions from 01 — 30 June 2016, scheduled to be published in Volume 11 Issue7 of Regenerative Medicine.


The governing Board of the California Institute for Regenerative Medicine (CIRM; CA, USA; ( approved investing $15 million in a partnership with Quintiles Transnational (CO, USA; to create a stem cell Accelerating Center. In return, Quintiles will provide researchers with the support and management services they need to increase the likelihood their clinical trials will succeed. CIRM projects run through the Accelerating Center will be given a discount on services. CIRM expects to receive a US$ 22.5 million, or 50 percent, return on its US$ 15 million investment.


Mesoblast (Australia; has regained full worldwide rights and full strategic flexibility to exploit its mesenchymal precursor cell technology (MPC) platform for the cardiovascular field as Teva Pharmaceutical (Israel;, Mesoblast’s key US partner, surrendered all rights to its heart failure treatment, leaving the local company to fund as much as US$ 100 million in medical trials before it could be ready for marketing. In closing trading, Mesoblast shares were down 42% at US$1.11, wiping more than US$ 300 million off its market value, and taking the shares to seven year lows. Teva’s decision follows the failure of Celgene to exercise a six-month option to partner some of Mesoblast’s research programs, which was only disclosed recently. The lead asset in this cardiovascular portfolio is Mesoblast’s Phase III product candidate MPC-150-IM for advanced chronic heart failure. The Phase III trial has enrolled over 230 patients out of a total of 600 patients with advanced heart failure, with the primary endpoint agreed to with the FDA for product registration being recurrent heart failure-related hospitalizations or deaths.



NASA (USA;, in partnership with the nonprofit Methuselah Foundation’s (VA,USA; New Organ Alliance (, is seeking ways to advance the field of regenerative medicine through a new prize competition. The Vascular Tissue Challenge offers a $500,000 prize to be divided among the first three teams that successfully create thick, metabolically-functional human vascularized organ tissue in a controlled laboratory environment. Related cells that are joined together are collectively referred to as tissue, and these cells work together as organs to accomplish specific functions in the human body. Blood vessels around the cells vascularize, providing nutrients to the tissue to keep it healthy. The vascularized,

thick-tissue models resulting from this challenge will function as organ analogs, or models, that can be used to study deep space environmental effects, such as radiation, and to develop strategies to minimize the damage to healthy cells. Studying these effects will help create ways to mitigate negative effects of space travel on humans during long duration, deep space missions.