Cells Weekly is a digest of the most interesting news and events in stem cell research, cell therapy and regenerative medicine. Tomorrow, a Nobel Prize Winner 2013 in Physiology or Medicine will be announced! Stay tuned!
1. BioTime finalizes the acquisition of Geron’s stem cell programs
This week, Asterias Biotherapeutics – a subsidiary of BioTime finished the acquisition of Geron’s stem cell assets. Long-awaited transition finally finished! The details of the deal you can read in press release:
Under the terms of the Agreement, Geron has contributed to Asterias its stem cell intellectual property, multiple lots of OPC1 drug product (hES cell-derived oligodendrocytes) used in the world’s first human clinical trial of hES-derived cells in subacute spinal cord injury, multiple lots of hESC manufacturing cell banks – the starting material to manufacture additional lots of OPC1 drug product and to produce dendritric cells for cancer immunotherapy, chondrocytes for cartilage and disc repair, and cardiomyocytes for heart disease.
So, Geron’s “stem cell dream” got back to Tom Okarma – a current person behind of Asterias and former Geron’s CEO.
It is very good news, because there is a big hope for continuation of those embryonic stem cell trials. However, it’s still unclear if spinal cord trial will be resumed or Asterias will decide to switch to other indications, such as multiple sclerosis and stroke.
2. Initiative to create an international standard for iPS cell banks
In the fresh issue of Cell Stem Cells, the famous stem cell researchers are proposing to develop of a global iPS cell standards:
Here we propose that an international assessment should be made of how immune incompatibility can best be managed and how a network of GMP HLA homozygous haplobanks could be operated.
I think, this is a great move!
Read more on CIRM blog.
Yet another article from the same issue of Cell Stem Cell provides recommendations for creation of clinical-grade iPS cell banks.
3. Is peripheral blood stem cell an organ?
Yes, said US agency HHS, which aims to regulate mobilized peripheral blood hematopoietic stem cells as such. They propose to do so in order to “preclude payment for it”. In other words, donors of mobilized blood should not be paid, since organs are not for sale:
Dan Salomon, MD, medical director of the Scripps Center for Organ Transplantation and president of the American Society of Transplantation, told MedPage Today that the rule will “remove any doubt that paying donors for HSC for transplantation was not acceptable.”
I’ve got some comments of transplant physicians here.
4. Tissue engineering for spinal cord injury – results of clinical study
The results of clinical study, assessing mesenchymal stromal cells on chitosan-laminin scaffold for reparation of chronic spinal cord injury, have been published this week:
Motor level improved four levels in 2 cases and two levels in 12 cases. Sensory-level improved six levels in two cases, five levels in five cases, four levels in three cases, and three levels in four cases. A four-level neurological improvement was recorded in 2 cases and a two-level neurological improvement occurred in 12 cases.
I find these preliminary results quite impressive.
This year (as well as previous year) I made in top 30 nominees. So far, I’m making in top 10. This is fantastic! I’m right between Pope Francis and Masayo Takahashi (the person behind the first ever iPS cell trial) – what a company! Thank you all for support! The poll is open and I’d encourage you to vote for the person, who “shakes the stem cell boat” this year.
6. Hurdles in advancing stem cell therapies – white paper by ARM
Alliance for Regenerative Medicine in conjunction with CIRM and Cell Therapy Catapult, have released a white paper, entitled: Key Tools and Technology Hurdles in Advancing Stem Cell Therapies. I’ve read this document Yesterday and I’d highly recommend to read it to every cell product developer! Very precise, concise and useful! Just one quote:
Ensuring that a cell-manufacturing process complies with the cGMP and chemistry, manufacturing and controls (CMC) standards of regulatory agencies means that the product is made in a safe, reproducible manner, but it does not necessarily imply that the process is sufficiently robust, scalable, and cost effective to achieve commercial success. cGMP compliance is not required at the pre-clinical stage, and developing a commercially viable manufacturing process is viewed by many as not economically feasible or premature in the absence of efficacy data.
In the companion report published in GEN online (http://bit.ly/1g0hLED), we present a snapshot of some of the quantitative metrics in the cord blood banking space and track the challenges in the field as it seeks to remake itself from purely a source of material for HSCTs to a source of stem cells for addressing a wide swath of therapeutics needs.
One of the interesting statistical data point, that he pointed out in report: “Annual turnover of cord blood units in public banks 1-3% of all units inventoried”. This begs the question: Is this sustainable?
And the answer to this question was given by Christopher Hillyer (CEO of the New York Blood Center) in his recent interview:
To become fiscally sustainable, public banks must decrease costs, increase distribution (revenue), or both. Many patients in need go untreated, so clearly there is a need for banking more units to increase the quality of matches. The world needs 1.4 million more cord blood units, and at the current cost of $5435 / unit that does not seem feasible.
… Dr. Hillyer’s message is clear: public banks must fundamentally change their business practices to survive.