Saturday, February 24, 2007

Viacell ABANDONS Cord Blood Stem Cell Expansion Program

IS IT ENOUGH?

Whilst many cord blood banks rather unscrupulously hype up the possibilities of stem cell expansion (in order to get clients to store whatever they have and believe in their technology), I've always asked the StemLife team to take a very careful view of the science and the practical realities*.

[As a side note, here in Malaysia cord blood banks claiming to compete with us - operate on the cheap using non-FDA approved storage systems- promote the usage of vials as a storage medium on the pretext that cells can be selectively taken one vial at a time for future expansion. Read on to see why this is a disingenuous marketing ploy...]


THE CHALLENGES OF EXPANSION

The reason why StemLife has taken a cautious approach towards the expansion technology are three fold.

Firstly, in order to expand stem cells, you'll need enough cells -the more the better- in the first place. As a crude analogy, you'll need enough lactobacilli to make yoghurt (too little and it will take too long, allowing other bacteria to destroy the process).

Secondly, sterile technique is absolutely critical; when you're growing the cells, you have to make sure that it contains only the cells that you're growing and nothing else. This requires not only human precision, expensive facilities and sterile reagents, but most importantly, the money to maintain everything in exactly this pristine sterile condition (many, many zeros in any currency).

Thirdly, knowledge of cellular morphology and function is also very important. No one I know would like to risk having cells injected into the heart forming liver or kidney tissue instead. This means identifying the cells and providing the assurance that the cells are indeed stem cells and nothing else.

Hence, any organization, private or public has to be prepared to have deep pockets and a lot of patience when venturing into this technology.


HOW DEEP ARE YOUR POCKETS?

I've been following Viacell's (VIAC) progress in this area for some time, not only because they were one of the first stem cell companies to announce their sincere interest and demonstrate their financial committment in this area, but also because I was kindly shown around their big and beautiful facilities two years ago in Boston.

It is unfortunate therefore to see this press release by Viacell on their decision to terminate the cord blood stem cell expansion project CB001 despite its apparent reported success but on the grounds that the process and product was unaffordable and commercially inviable due to other alternatives.

"What's the alternative?" I hear you ask. The reason why Viacell made the tough commercial decision to cut their losses was that the preferred methodology by transplanters in the US is a dual cord stem cell transplant (using 2 cord blood stem cell units instead of just 1). The results of the expanded product were as good as and in some ways slightly better in the initial trial, but I suspect that the cost did not justify only small improved outcomes. I would say that it was a wise commercial decision by Viacell, and an acknowledgement that what scientists dream and love to do, is not always feasible for clinical practice.

I learned this a long time ago when I was still in research, that what looks good on paper does not necessarily transform into a money spinner despite the winning ideas and long hours of toil.


A GOOD CEO KNOWS WHEN TO QUIT

By cutting the budget for this research and focusing on service improvements, Viacell expects to finally achieve profitability in 2008 for the first time since their listing a few years ago (this is probably also true of many of the other cord blood banks which have committed much of their funding to very costly research, sacrificing their bottom line).


"Given these results and the shift in the treatment paradigm in transplant medicine from single cord to two cord transplants, ViaCell has made the decision not to advance CB001 in future clinical trials. As a result of the reduced clinical and development costs related to CB001, along with anticipated continued growth in its operating business, ViaCell expects to become cash flow positive in the first half of 2008."


Now, Viacell intend to focus on cord blood stem cells for cardiac applications, which I think is probably more interesting and may pose less life-threatening consequences for patients.


"We are committed to continuing to grow our operating business, advancing ViaCyte(SM) through a pivotal clinical trial, which, if successfully developed, will leverage our sales and marketing infrastructure, and working to advance our cord blood-derived cardiac program," said Mr. Beer. "We are already generating cash flow within our ViaCord business and we anticipate continued growth in 2007. As a result, given our reduction in clinical and development costs related to CB001, we expect ViaCord's contributions to the overall operation will allow us to turn cash flow positive in the first half of 2008."


So if you are specifically told by any stem cell company that stem cell expansion technology is available today, they aren't lying, but don't forget to ASK them whether:

1. Your unit baby's cord blood unit has sufficient stem cells to be expanded,

2. Who's offering the service (full due diligence here) and how successful the treatments outcomes have been and what assurances they provide otherwise;

3. And, specifically at what cost.


STEMLIFE BELIEVES IN CHOICES

The way I read the cord blood stem cell tea leaves, if you banked a unit of stem cells and it is not enough, seek other matching units to combine with your own or consider joining StemLife's adult stem cell banking program.

We believe in continually providing affordable and accessible options to our clients... and making stem cell banking a more than once in a lifetime opportunity. :)



*We do not turn away clients who express their wish to proceed but provide them with a cautious advisory to indicate if the stem cell counts are below what we would normally expect. StemLife also provides a full refund for those clients who decide not to proceed to store, and we usually ask them to let us know when they'll be having the next baby (success second time round).

StemLife has a joint research project with the National University of Singapore at very initial stages which differs from Viacell's approach, you can read more about it here.

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