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Category Archives: Stem Cells

Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

Seven months after the California stem
cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass.,
the company has yet to receive any of the cash from the Golden State.
Kevin McCormack, a spokesman for the $3
billion agency, this week said negotiations are still underway with
the bluebird, which is planning to go public,  but did not elaborate. Post-award negotiations are
common at the agency, but generally take much less time.
The cash from CIRM is scheduled to
assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a
rare blood disorder that can cause widespread organ damage
and premature death.
Earlier this month, bluebird bio, which
prefers the lower case lettering for its name, announced that it
intends to take the company public in an $86 million offering. In
March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per
product in potential option fees and clinical and regulatory
milestones. The CIRM grant is conditioned on a matching commitment
from bluebird.
Cash from the stem cell agency can only
be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored
at 73, the company said,

“We will have at least two clinical
sites in California, and more likely up to 4 sites, 2) our viral
vector manufacturing will occur in California, 3) our cell processing
will occur in California, 4) we will hire several consultants and
full-time employees within California to support the program.
Overall, several million dollars will be spent employing the services
of people, academic institutions, and other companies within the
state of California.”

The company has said that it is working
with Donald Kohn at UCLA and Elliot Vichinsky at Oakland's Children's
Hospital.
The bluebird web site lists a
California location for bluebird at 1001 Bayhill Dr, Suite 200, in
San Bruno, which is south of San Francisco. An Internet search
indicates that is a generic address for a number of business
including a realty firm, a roof repair business and a family law
attorney. The California Stem Cell Report has asked bluebird to
clarify the nature of the address.
In an interview last October with Ron Leuty of the
San Francisco Business Times, David Davidson, the lead scientist on
the project, said,

“We began the process (with CIRM)
early in (2012) but discussions have been going on for over a year
about potentially pursuing this.

“The interaction with CIRM has been
extraordinarily collaborative. We had contact with the coordinators
at CIRM that helped us manage the process. It took a lot of effort on
our part to put together a dossier providing support for our program.
It was really like a mini-regulatory filing — on the science, the
preclinical toxicology work that we’ve done, a detailed plan for
the trial, a detailed plan for the budgets, a detailed plan on how we
intended to spend the CIRM money in California. That was an important
part of it. They wanted a clear plan on how this investment would be
spent."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/zR-Ht90u_7o/bluebird-bio-of-massachusetts-still.html

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Vatican Funding for California Stem Cell Agency?

So what's with the Vatican sending cash
to the California stem cell agency? One would imagine that is an
improbable event since the agency is involved in human embryonic stem
cell research, which is an anathema to the Roman Catholic church.
However, CIRM President Alan Trounson
earlier this week disclosed the payment in an interview with Patt
Morrison
of the Los Angeles Times. He said,

“Last
year I was invited to the Vatican to
present a paper, but when I sent in a summary of what I was going to
say, they decided not to have it. They sent a check to the treasurer
of California and the treasurer rang us up and said, "What the
heck is this check from the Vatican for?" It was for the
inconvenience!”

We wanted to know a little more about
this so we queried the agency about the matter. Kevin McCormack, a
CIRM spokesman, said,

“The money was actually a wire
transfer from the Vatican to us for $453.23 and it went to CIRM's
account. It was to reimburse us for money spent on plane tickets,
etc., for Dr. Trounson to attend the Vatican conference on stem
cells.”   

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/bOQKBXJGmJ8/vatican-funding-for-california-stem.html

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Monterey Newspaper Chides California Stem Cell Agency

The California stem cell agency and its
former chairman, Robert Klein, came under sharp criticism this week
in an editorial in the Monterey County Herald newspaper.
The editorial cited articles on the
California Stem Cell Report dealing with a $21,630 gift by Klein to
the agency, his employment of the vice chairman of the agency and the
violation of the agency's conflict of interest policies by a grant reviewer.
The editorial was headlined "State Stem Cell Agency Still Up to Old Tricks." The piece said,

“Robert Klein is no longer chairman
of California's stem cell bureaucracy, but it is still doing things
his way. Which is too bad for all concerned.

“Klein is the former developer and
financier who wrote and sponsored the ballot measure that created the
California Institute for Regenerative Medicine. The ballot language
practically guaranteed he would be the chairman, and he ran the
agency the way he ran his businesses, using undisclosed side deals
and other machinations to create webs that outsiders could never
penetrate.

“Now, Klein has been replaced as
chairman, but he is still up to his old tricks.”

The editorial concluded,

“Much has been said about the agency
setting a new more straightforward direction now that Klein is gone,
but so far it seems to be following a twisting and expensive path
toward irrelevance and litigation.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SGmn7k9T1Vw/monterey-newspaper-chides-california.html

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California's Alpha Stem Cell Clinics: Open in 2014, Six to Eight Locations

The San Francisco Business Times
yesterday said that the first Alpha Clinic sponsored by the $3
billion California stem cell agency could open as early as 2014.
The timing was disclosed by CIRM
President Alan Trounson in an article by Ron Leuty, who also reported
that that Trounson's $70 million proposal (see here and here) would involve as many as
six to eight clinics. The locations of the clinics was not disclosed
and would be subject to a competitive RFA. However, Leuty's piece
mentioned UC San Francisco and Stanford.
The article also said initial
treatments might focus on eye disease, “brain therapies” and
spinal cord injuries.
The Alpha Clinic plan is scheduled to
come before the CIRM board in late July. The proposal is aimed at
speeding stem cell treatments and creating something of a one-stop
shopping experience for patients.

Once the CIRM board approves the
concept, an RFA will be issued and interested institutions will have
to submit bids and compete for funding.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/So_NOlmLU2E/californias-alpha-stem-cell-clinics.html

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California’s Alpha Stem Cell Clinics: Open in 2014, Six to Eight Locations

The San Francisco Business Times
yesterday said that the first Alpha Clinic sponsored by the $3
billion California stem cell agency could open as early as 2014.
The timing was disclosed by CIRM
President Alan Trounson in an article by Ron Leuty, who also reported
that that Trounson's $70 million proposal (see here and here) would involve as many as
six to eight clinics. The locations of the clinics was not disclosed
and would be subject to a competitive RFA. However, Leuty's piece
mentioned UC San Francisco and Stanford.
The article also said initial
treatments might focus on eye disease, “brain therapies” and
spinal cord injuries.
The Alpha Clinic plan is scheduled to
come before the CIRM board in late July. The proposal is aimed at
speeding stem cell treatments and creating something of a one-stop
shopping experience for patients.

Once the CIRM board approves the
concept, an RFA will be issued and interested institutions will have
to submit bids and compete for funding.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/So_NOlmLU2E/californias-alpha-stem-cell-clinics.html

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$70 Million Alpha Stem Cell Clinic Proposal Draws Reader Comment

In addition to the comments filed online in connection with the $70 million proposal to create Alpha Clinics in California for stem cell treatments,  two other readers commented privately in emails. 
One came from a close observer of the
stem cell agency who said, “If done right -- and I'm sure you and I
agree that is a big 'if' – it could be an outstanding legacy.”
The other comment came from a
physician-researcher at a major California institution and was longer
and more critical. Here is the text.

“Another boondoggle for some medical
schools but made to order for private operators like for profit
cancer, dialysis, and laser eye specialty clinics that do one
procedure.  I can see each of the medical schools gifted with
one as they each were gifted with about 25 million dollars for stem
cell institute buildings; and CIRM and (Irv) Weissman's companies
like Stem Cells, Inc., getting a piece of the action as well.  Of
course the deans and chancellors on the CIRM steering committee will
vote for it. How can they not? It's money in their pockets.

“This has the fit and feel of, say,
old Latin American Laetrile clinics or offshore clinics offering
suspect surgeries or injections for cancers, Parkinson's disease, and
the like.  It makes no difference that they are set up in
California.  CIRM will pay for an unneeded infrastructure that
will be empty space and staff sitting on their hands 99% of the
time.  Or worse yet, CIRM will pay but the space will be used
for other things, other clinic procedures paid for by insurance.  

“Now (CIRM President Alan) Trounson and
CIRM want to get into the medical tourism business making California
a 'go-to place' for stem cell treatments.  They want to start
with bone marrow injections and transplants, procedures that cancer
centers do regularly.  All CIRM needs is a drug or treatment. 
It's not like there are tons of drugs out there and the only barrier
is the lack of clinical space and capacity.  The start up time
for any one drug is very long.

“NIH at various times has tried to
organize clinical trials groups with infrastructure, like quick
reaction forces, ready to gear up for a new trial at the drop of a
hat. They mainly did nothing but suck money, kept staff employed,
because there are generally few drugs ready for early human trials
and each treatment that is brought along requires a unique contract,
ethics reviews, and different facilities, equipment and staff than
planned for.  The latest incarnation are CTSAs or CTSIs,
clinical and translational science centers funded by the federal NIH
that most if not all California medical schools already have.

“The CIRM clinics are going to be
generic stem cell clinics advancing California tourism.  Come to
California, we will inject stem cells for any illness, in any part of
your body, never mind that cancer is different from heart disease is
different from bone disease is different from brain disease, no
matter.  Next step is for CIRM to form a travel agency with
discounted air and Ritz Carlton packages for patients and extended
family non-stop from China.  There is likely considerable
revenue to be generated here and Trounson, Weissman, and (Robert)
Klein
(former CIRM chairman) should find a way to benefit. It sounds
so wonderful!!  The public will love it.  Now all they need
are some treatments.  Love the name: Alpha Clinics, they
wouldn't want to start with Beta test clinics when they can go big
from the get-go.  What an irresponsible waste.”    

The other comments can be found at the end of the original item or in the column to the right of this item, headed "recent comments."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/nKbicxl9mzA/70-million-alpha-stem-cell-clinic.html

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