StemCell Therapy

Robert Klein, who served 6 ½ years as the first chairman
of the $3 billion California stem cell agency,  testified before the agency's board for the first time on July 26, 2012. Klein, a real
estate investment banker and attorney, spoke on behalf of two applicants whose
grants had been rejected by the agency's reviewers. The appearance
has raised questions about the propriety of Klein's actions.

Here is a link to an item on his appearance. Here is the text of
his comments as reported in the transcript of the meeting.

“As the board knows, I've never addressed any grant from the
floor. It is critical here to understand that we have here
StemCells, Inc., which is the only company in North America
and, for that matter, maybe in the world, that has had two stem cell
therapies in the brain with these specific neural stem cells. They
have a huge body of experience here. 

“Secondly, one of the fundamental issues here that it (the
company's grant application) was downgraded on was the issue of the
fundamental concept, the platform concept, of injecting two focal
injections in the brain, in the hippocampus of the brain. It's
important to note that I've sat on three (CIRM)peer reviews where the
scientists really affirmed this specific approach with extremely high
scores, three different views. All right.

“So it's very important to realize we have a standard deviation
here of 12 (on the review scores). These scientists were completely
split. With some recusals on that panel, if you have 12 or 13 that
can really vote, three or four very low scores can bring it out of
the funding category all the way down. It is in the region where
this board is looking where the other three peer reviews, right,
early translation, the one before that was the planning grant review,
that the hippocampus was a good platform.

“Then they said the key weakness was you can't show migration.
Dr. Laferla (a co-PI on the application) has told me that
today the Journal of Neuroscience accepted the publication of
the data demonstrating migration. It was stated previously in the
application, but it wasn't accepted for publication. It now is.
That is the fundamental weakness that they identified in this
approach.  

“So we have a reaffirmed approach to the hippocampus by three
different peer review groups and a substantial portion of these
reviewers along with data dealing with the weak point. I'm sorry it
happened today. The data was out there, accepted for publication
today, means that it should definitely fall into this category. And,
of course, Dr. (Alan) Trounson (president of CIRM) wouldn't
have been able to review that in process because he was recused from
this grant by his own voluntary recusal. So the progress of this
data being accepted for publication is new information today. 

“If I look at the entire history of CIRM, as Leeza (Gibbons,
a CIRM director) says, building up to this point, we have reaffirmed
this approach from the very beginning with Dr. Laferla, with multiple
scientific approvals, and board approval, and we have the best
company in North America with the greatest experience with these
neural stem cells, with the best researcher we have for the potential
to address this disease, and we have brand-new data that demonstrates
and totally contradicts the key weakness on which it was downgraded.”

“This is the only other disease team grant I will address. Very
specifically, this was a disease team grant that I was on the peer
review in the planning grant stage. There are some fundamental
issues here. Is the international company on which the one antibody
that's not coming from Stanford, the two for sorting are
coming from Stanford, is the other antibody coming from this
international company a commitment that you can rely on? 

“The reviewers said this was a showstopper. That's the word they
used. They made a decision this was a showstopper because they did
not believe the company because they thought that the documentation
was inadequate. You now have a letter that goes into great
proprietary depth about the depth of this company's commitments
written by the head of development and translation internationally
for the company. 

“If we cannot depend on company commitments of this type, and
you will review the letter in executive session, if you have one, I
will not understand how we'll be able to collaborate with companies
with proprietary products and processes where they're making
commitments to academic institutions of the highest standard. I
believe this company is going to perform. I was on an hour call to
confirm with eight members of that company their level of commitment,
and I am completely convinced by that point. 

“The review is completely factually wrong on this issue about
the other two antibodies for sorting this. Dr. (Irv) Weissman
has just said they have not only been developed, they have been used
in clinical trials. There's data on them. And they are, in fact,
being thawed under FDA direction to reuse in this trial. 

“So I believe there's a major factual difference. Remember with
Karen Aboody there was a major factual error that was pivotal
in elevating that, and we found tremendous performance on that grant
by Karen Aboody of City of Hope. 

“So you have a decision to make. As a risk issue, do we believe
this company? Finally, this is broader than SCID. 

“Donald Kohn has written a letter that's in the public
domain that I suggest you read. It makes it very clear that opening
the niche for repopulating the immune system without chemotherapy and
radiation is a key contribution to every form of genetically modified
stem cells for an entire range of childhood diseases and other
genetic diseases in addition to therapies like sickle cell or aids. 

“I suggest that that profound contribution that can be made to
the field is a risk that is worth taking early on because of his
contribution to so many other areas. You have 12 other letters from
North America's leading pediatric geneticists that fundamentally
provide extraordinary support for this position and this approach.”

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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