Category Archives: Stem Cell Therapy

As the California stem cell agency
pushes ever more aggressively to turn research into cures, the second
largest share of its awards, in terms of numbers of grants, has gone
to efforts involving induced pluripotent cells, also known as
reprogrammed adult cells.

“All the talk and the slew of
publications about potentially using iPS cells to develop therapies
to help patients is exciting in theory, but unfortunately the reality
is that it is not entirely clear if most researchers are, from a
legal standpoint, even allowed to develop and commercialize iPS
cell-based therapies at all.

“The patent landscape for iPS cells
is complicated to put it mildly. A
Google patent search for “induced pluripotent stem cells”
produced almost 200,000 results.

“A search for “cellular
reprogramming produced more than 1,000
results.
I’m not sure all of these results are
really separate patents, but still….that’s a big complicated
mess.…..

“It is no exaggeration to say
there are likely dozens of institutions around the world wanting to
commercialize iPS cell-based products.

“Will they all have to pay expensive
licensing fees or end up in court?
…or will the patent holders
voluntarily and freely allow others to commercialize iPS cell-based
medical treatments?

“I don’t think so.

“This could get really messy.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/ZX0PoUag-pE/a-patent-war-on-ips-one-researchers-view.html

“I must take issue with your entry,
'Robert Klein Gives $21,630 to the California Stem Cell Agency,' May
05, 2013.

“When
Bob Klein donated $21,630 to the California stem cell program (to
allow scientists to attend a research conference in Japan) he was
doing exactly what he always does: advancing research to ease
suffering and save lives.  The scientists needed a way to attend
a top-level conference. Believing in the benefits of researchers
sharing thoughts, Bob paid for their trip.

“Unfortunately,
your article appears to imply corrupt motivations.

“'A
seemingly innocuous…gift…generated a wave of special favors for
(Klein) that stretched out to include a gold mining multimillionaire
from Canada.'.
A 'wave of special favors?'  The article
states that 'Klein wanted to meet with the six science officers…'
 and to get their impressions on the conference.

“Is
that not natural? First, would it not be helpful to hear from the
scientists if the trip was worth the time and expense? Second, Bob
Klein works in real estate, a full-time job. He does not have the
scientist’s automatic involvement to keep him up to speed on
everything new in regenerative research. But he wants to know the
latest: what is working, what is not. He is always eager for a chance
to speak one-on-one with an expert.

“He met with a Canadian
millionaire? Why is this shocking? The millionaire supports stem cell
research; so does Bob. California is working closely with Canada on
several projects; they pay their scientists, we pay ours; more bang
for the buck. If there is a person with the resources and will to
advance Canadian research, it is natural that Bob would want to
develop a deeper interest in the shared research.

“And why
should Klein be criticized for supporting a research project
attempting to alleviate Alzheimer’s? He saw his own mother die of
the disease, after losing the ability  to recognize her own son.
 I am familiar with that particular Alzheimer’s project, and
it had some amazing results, restoring memory to laboratory rats.
This was a water maze test, and the rats recovered the memory of a
pathway out of the water, which they had forgotten. To the best of my
knowledge, no one else in the world had achieved memory return, and
the project deserved the most serious consideration.  Yes, the
board of directors voted against the Grants Working Group; it is not
only their right but their responsibility to exercise judgment, and
not merely be a rubber stamp for the GWG.

“There is also the
matter of free speech. Anybody else in California can come to the
meetings of the program and voice their opinion—why should Klein be
denied the right to voice his opinion?

“Bob Klein owns no
stem cell stock, no biomedical enterprises. Financially, supporting
stem cell research has cost him a great deal. This is the man who led
the fight to build the California stem cell program, donating roughly
six million dollars, taking out loans on his house to help finance
Proposition 71. And, for six years (without salary) he worked
full-time as Chair of the Board of the oversight committee.
Physically and emotionally, it has been an exhausting decade for him.
He has not profited in any way, except to see the advancement of
research for cure.

“Passing a $3 billion stem cell program
in the midst of a recession was like relocating Mount
Everest—seemingly impossible, but he did it anyway. He moved the
mountain. Thousands of people helped, but one man made it possible.
Without Bob Klein, California would not have the greatest stem cell
program in the world: challenging diseases considered incurable since
the dawn of time. That he should continue to support it, with his
dollars, time, energy and creativity, is commendable.

“Sometimes
a good deed is just that: no sinister motivations, no secret
agendas-- just a positive action which benefits all.”  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/hW_Zc6qeDYY/patient-advocate-reed-defends-klein.html

Last week UC Davis stem cell researcher
Paul Knoepfler and Scripps researcher Jeanne Loring engaged in an
online Q&A that touched on patents and how they can stifle
research and discourage development of therapies.

“Dan Ravicher is the lawyer behind
several big patent cases, including the recent Supreme Court case
challenging human gene patenting (Myriad), and a challenge to
Monsanto's restrictive enforcement of its patents on genetically
modified seeds. 

“I'm lucky that he is also the lawyer
working with John M. Simpson (of Consumer Watchdog) and me to
challenge the WARF patents.  Currently, we are getting ready for
another year of appeals and counter-appeals on the third of WARF's
three patents that give them control over all human embryonic stem
cells.

“This is Dan's summary of the current
situation:

"'We filed challenges at the
Patent Office to all three of WARF's hESC patents. During those
challenges, WARF agreed to narrow all three of the patents, and
they also loosened their licensing requirements. But, even
though the patents were narrowed, we still think they're invalid, and
thus disagree with the Patent Office's decision to re-issue them in
the narrowed forms. Unfortunately, due to the age of the patents and
changes in the law, we were only allowed to appeal one of the three
decisions, and that appeal is now pending at the Court of Appeals in
Washington. But, we expect the decision in our appeal will affect
the validity of the other two patents, since they're all basically
on the same technology." 

“The 'narrowing' of the patents has
had an unexpected consequence.  Before the narrowing, WARF's
patents would have covered iPSCs as well as hESCs. After the
narrowing, they can only claim hESCs.”

“Patents
on fundamental things --
genes, human embryonic stem cells, iPS cells --
allow the patent holder to have a monopoly, preventing anyone else
from using whatever they’ve patented.

“Patents
are supposed to stimulate investment in development.  Why, as
Justice Scalia said last week, would anyone have the incentive to
study a gene and, for example, develop diagnostic tests, if they
couldn’t prevent everyone else from working on that gene?

“But
patents also stifle competition and the advances that come from
having many different groups studying the genes or cells.  One
of the main reasons I returned to academia was so I could have
freedom to study human ES cells without worrying about getting
threatening letters from a patent holder, demanding that I either
stop working on the cells or pay a steep licensing fee.

“There
will inevitably be problems commercializing iPSC-based therapies and
assays, because at least three institutions own patents on aspects of
iPSCs.  I’m paying attention to the patent 'landscape,'
but have decided to deal with those problems when they arise, and
hope that the iPSC patent holders realize that the potential of these
cells is too great to keep to themselves.  It would be better
for all of us if the issue of stem cell patents never has to be
decided in the Supreme Court.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/fXlAaqQbBAs/warf-hesc-patent-update-seven-years-and.html

Here is the text of the initial
response from Robert Klein, chairman of the California stem
cell agency until July 2011, to questions from the California Stem Cell Report (CSCR)
concerning his $21,630 donation to the agency. The questions posed by
CSCR on precede the response by Klein. Here is a link to a story on
the matter.

“Why did you give the agency the
money?
“Did you place on conditions on its
use?
“Did anyone connected with the agency
indicate in advance  that your donation would be desired? If so
who? Who did you deal with primarily on the donation -- Trounson,
Thomas or...?
“The donation came one month after
grant reviewers rejected StemCells Inc.'s Alzheimer's application. Do
you think it was appropriate to make the donation and then ask the
board twice to override its reviewers?
“Do you think the donation and
subsequent action on StemCells, Inc.'s Alzheimer's application will
negatively color the perception of future efforts by CIRM at private
fundraising?”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/57qJcfMUql0/the-klein-donation-text-of-robert_5.html

Here is the text of the key comments
from the California stem cell agency in response to questions from
the California Stem Cell Report (CSCR) concerning the $21,630
contribution by Robert Klein. Here is a link to the full story on the matter.

“Is CIRM concerned about the
appearance created by the donation from Bob Klein to enable scientific
staff to attend the ISSCR meeting in Yokohoma, coming one
month after the GWG (the review group) rejected StemCells Inc's Alzheimer's application
and one month before the July Board meeting that led to the approval
of the award?”(Editor's note: It was actually two months before the board meeting.)

“No, the two items are entirely
separate with no connection. Item 1  involved Bob Klein making a
donation to allow science officers to attend a critically important
scientific meeting on stem cell research.  The science officers
 had originally planned on attending but then were told they
could not because of cuts in our out-of-state travel budget – Bob
Klein’s donation, without using state funds, enabled the science
officers to attend.  Item 2 is an ICOC decision to fund a
research project that they felt had promise and was important for the
people of California.”

“Under the Gift Policy, the President
had the authority to accept Mr. Klein’s generous offer as a 'Direct
payment or reimbursement by third parties for the costs of general
operation or grant management administrative activities.' (Gift
Policy, Sec. III(A)(2).)  Because CIRM receives gifts only
infrequently, CIRM staff determined that it would be more efficient
to report gifts to the Board on a semi-annual basis.  Mr.
Klein’s donation was the first gift CIRM had received in some
years.  Due to the lack of additional donations, a transition in
CIRM’s finance office, and an oversight, CIRM staff has not yet
presented a report including Mr. Klein’s gift.  Staff plans to
report Mr. Klein’s gift as part of the finance report at the May
Board meeting.  Because the President had the authority to
accept the gift pursuant to section III(A)(2) of the Gift Policy, it
did not require a commitment letter.  (See Gift Policy, Sec.
III(C)(1) ['A Commitment Letter is not required for gifts described
under III.A.2., 3. and 4.'].)  However, consistent with the
policy, Dr. Trounson sent Mr. Klein a letter of appreciation, a copy
of which we have already provided you.”

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/dQImAqKe0Ys/the-klein-donation-text-of-stem-cell.html

A seemingly innocuous $21,630 gift to
the California stem cell agency has kicked up new questions about a
controversial $20 million research award and generated a wave of
special favors for the donor that stretched out to include a gold
mining multimillionaire from Canada.

Robert Klein Elie Dolgin/Nature photo

The gift was made last May by Robert
Klein, chairman of the stem cell agency from 2004 to July 2011, but has never
been publicly reported to the agency's governing board as required by
its own regulations. 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/FefPhO0IEiY/cash-and-favors-robert-klein-gives.html

Here is the text of comments from
Robert Klein, former chairman of the California stem cell agency,
concerning his $21,630 donation to the agency and subsequent actions
by the agency. Klein's comments May 1 came in response to questions
from the California Stem Cell Report(CSCR) on April 30. The text of
the inquiry from CSCR precedes Klein's response. Here is a link to the story on the matter.

"I have sent the following to CIRM
asking for their response and am offering the same opportunity to
you. Here is what I sent the agency:
'The documents that I have received so
far show that after Klein gave CIRM $21,000 the agency instructed six
of its science officers to give him special access to their
activities and apparently did not object to additional instructions
from another member of the public, Melissa King, to provide Klein and
her with written summaries about their activities at the ISSCR
convention and “details” about their work at CIRM. Email
addresses of the six were also provided to Klein, who may have
additionally received their cell phone numbers although that is not
entirely clear. The CIRM documents show that the six were told to
engage in one-on-one sessions with Klein, which actually included a
third person, a wealthy Canadian mining company executive. One
document indicates that the science officers should assist in
fundraising for CIRM by identifying areas of “special importance”
to Klein and 'other donors.'
"'Additionally, Alan Trounson, at
Klein's request, invited the mining executive to a closed door
session involving the agency's international partners, a session at
which presumably valuable, little known scientific information would
be discussed and future directions charted. Trounson specifically
told the executive that it was Klein who asked that executive be
invited to the session, adding to Klein's clout in any business or
other dealings that Klein might have with the executive.'

My questions to CIRM deal with the
special treatment that was provided in connection with your donation.
I would ask you if you think that state agencies should provide this
sort of extraordinary treatment for individuals who donate to the
agency. At the very least, doesn't this raise questions about the
integrity of the agency and doubts in the public mind about whether
it can be fair and even-handed in its activities?

"In April or May of 2012 I committed
to contribute a charitable donation to CIRM to cover the travel costs
for 5-7 additional science officers to attend the International Stem
Cell Conference in Japan.  It is important to CIRM that their
science officers understand the cutting edge research being developed
around the world so that CIRM does not fund redundant research; but,
to the contrary, the science officers understand how to create
networks between California scientists and scientists in other
foreign countries who are doing complementary research that can
potentially accelerate the advancements of therapies for patients. I
do not hold any financial interest in biotech companies. I have
historically been involved in encouraging international collaboration
to advance medical therapies; for patients, every day of delay in the
development of a therapy is a delay they cannot afford. To
conceptually document the value of additional scientists traveling to
these meetings, it was discussed that there should be conceptual,
bullet point summaries about the value for CIRM obtained through the
scientists discussions at the international conference.  The
idea was to create bullet points of information about a few of the
most meaningful scientific concepts and contacts the science officers
benefitted from each day of attendance at the conference. I did not
participate in the selection of the science officers who attended and
I did not play any part in determining what activities they
participated in. There were two fundamental goals to the very short
one-on-one sessions that were arranged at "down time" that
would not conflict with their other activities. The first goal was to
conceptually understand if each of the science officers believed that
the benefit to the agency was sufficient to justify the cost of their
attending, when considering the learning and contacts they had gained
which might accelerate research and therapies for patients. The
second goal was to assist universities and non-profits, principally
in Canada - a research partner of CIRM - in advancing their
contributions from an existing donor or donors.

"The Canadian mining executive had an
important history in contributing to the International Stem Cell
Society and to Canadian non-profit research institutions. This
individual has an expert background in mining and a passionate
personal commitment to medical research; but, he does not engage in
technical discussions of research. On a conceptual basis it was
important for him to understand the spectrum of medical advances
towards therapies. His additional contributions to Canadian
non-profits could assist Canada in collaborating with California on
more international research, with California only funding the
research done in California and the donor helping to fund the
research done in Canada. No specific grant applications were
discussed. Finally, the discussion with the international partners
focuses on the funding process and funding collaboration it does not
discuss any individual grants. The value of international
collaboration and the benefits of collaborating with new
international partners is discussed. Scientific theories and
individual grants are not discussed and new scientific information is
not presented. I attended this session of international partners to
support international collaboration; again, I do not hold any
financial interest in any biotech organizations. Additionally, I do
not have any business or financial relationship with the Canadian
mining executive. The Canadian executive, based upon family and
friends who have had chronic disease, is a significant donor to
non-profit research institutions in Canada. All of my activities, the
donation and the encouragement to develop information to validate the
future benefits of science officers traveling to international stem
cell conferences were focused on benefitting California patients with
chronic illness or injury and the agency formed through Proposition
71."

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/SBGFem2qPWo/the-klein-donation-text-of-robert.html

Here is the email that Melissa King, an aide to Robert Klein, sent to the six science officers from the California stem cell agency. King was executive director of the CIRM governing board when Klein was chairman of the agency from 2004 to July 2011. Here is link to the story involving Klein's $21,630 gift to the agency.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/4fqob6pGa2A/the-klein-donation-memo-from-klein-aide.html