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Thanks Linda; I think your analysis is spot on; unfortunately.Charlotte

Linda J Herman <[log in to unmask]> wrote:Charlotte,
Good questions...
I think we need to look at his full testimony and perhaps read between
the lines.
He presents a summary of the stem cell research supported by the NIH
since Aug 2001 -
and calls it "the first steps towards understanding how stem cells might
be used to treat injuries and diseases."
"... I can report to you today that NIH’s implementation of the policy
set by the President on August 9, 2001 has enabled the field of stem cell
research to advance. We continue to acquire new knowledge about human
embryonic stem cells (hESCs). "
and
"...Human embryonic stem cell research is still in its nascent stages,
and there are many basic research studies that will be required before we
can begin to plan clinical trials. NIH is supporting preliminary research
to understand how to direct differentiation along specific pathways, to
establish techniques for isolating specific cell types, to control cell
proliferation, and to control interactions between the host immune system
and transplanted cells that might mediate graft rejection. ..."
and that:
"The NIH will continue to monitor the state of the science and assimilate
the body of research evidence in order to make informed, evidence-based
recommendations on this important issue. "

I don't know what Dr. Zerhouni's own personal views about embryonic stem
cell research are, but as the Director of the NIH he has to carry out the
policies set by the president. I think he's saying that at the current
time the limited cell lines are sufficient for doing the basic research
that will move the science further ahead. Some researchers agree with
this, others such as the researchers who testified at the hearing do not.

see:
http://www.senate.gov/~appropriations/subcommittees/record.cfm?id=204164
and
http://www.senate.gov/~appropriations/subcommittees/record.cfm?id=204163
for their testimonies.

Zerhouni says that the NIH will monitor the research progress using the
limited lines. If they determine that more lines are needed - will Bush
change his policies? I am pessimistic about that ever happening.
It seems to me that the embryonic stem cell research translational
research - research that will result in treatments and cures -- is going
to happen thru commercial and private funding - not thru the NIH , and
probably not in the U.S. -- at least not while George Bush is in office.
And without the full support of the NIH it is going to take longer to
develop those treatments.

May 22, 2003
text of
Labor HHS Subcommittee Hearing: Statement of NIH Director Dr. Elias
Zerhouni
http://www.senate.gov/~appropriations/subcommittees/record.cfm?id=204165
-------------------------------------------------------------------------
-------

Mr. Chairman, Senator Harkin, and Members of the Subcommittee, I am
pleased to appear before you today to testify about the progress of human
embryonic stem cell research. In FY2002, NIH spent approximately $11
million for human embryonic stem cell research to increase the
availability of stem cell lines for federal research, train scientists
how to use these technically-challenging cells, and conduct basic,
pre-clinical research that represents the first steps toward
understanding how stem cells might be used to treat injuries and
diseases.

More than 60 investigators at 48 institutions have received NIH awards,
including 14 investigator-initiated grants and 44 administrative
supplements. The administrative supplements allow investigators to
rapidly incorporate research on human embryonic stem cells into their
ongoing work. As you know, there are 78 lines fully eligible for Federal
funding, in various stages of development. NIH support has helped
increase to 11 the number of human embryonic stem cell lines that are
widely available for all researchers. More lines will become available in
the future, as we help the scientific community capitalize on this
opportunity. I can report to you today that NIH’s implementation of the
policy set by the President on August 9, 2001 has enabled the field of
stem cell research to advance. We continue to acquire new knowledge about
human embryonic stem cells (hESCs). Some of the significant discoveries
include the following research findings.

• NIH-supported researchers at the University of Wisconsin recently
succeeded in replacing a specific stretch of DNA in human embryonic stem
cells. This technique, called homologous recombination, opens the door to
scientists who want to study the function of specific genes within these
cells and also provides a way to modify hESC-derived tissues in a very
precise matter for use in treating patients.

• Scientists at NIH have been able to demonstrate that differentiated
mouse embryonic stem cells can be directed to become specialized cells in
order to repair damage when transplanted into the brain or spinal cord.
This finding could lead to the development of replacement therapy for
cells that are destroyed through injury or disease, such as stroke,
Parkinson’s disease or Alzheimer’s disease.

• In vitro studies have produced more specialized cells from human
embryonic cells that might be used for blood cell transplantation
therapies for patients with blood malignancies such as leukemia or
myeloma.

• Scientists are currently working to identify those genes that are
involved in the differentiation of hESCs, as well as those genes that
permit embryonic stem cells to self-renew. This knowledge, along with
research involving gene transfer techniques, potentially will allow
scientists to coax hESCs into becoming insulin-producing beta cells to
treat insulin-dependent diabetes.

• Until recently, all hESCs were grown on mouse feeder layers. Now
scientists are establishing conditions that allow hESCs to grow in the
presence of human feeder cell layers. NIH-supported scientists in the
United States, using stem cells eligible for federal research, have
tested the ability of human feeder cells derived from fetal or adult
tissues to support the growth of human embryonic stem cell lines. Both
fetal and adult human feeder cells were able to support and maintain the
cells in an undifferentiated state. Also, we have seen published research
on the existence of one cell line, developed in Singapore, that was
created and developed using human feeder layers. However, the Food and
Drug Administration has informed NIH that, given the complexity of this
area of research, it is difficult to predict whether newly derived human
embryonic stem cells grown exclusively on human feeder cells would result
in clinical trials sooner than the existing eligible cell lines either
grown exclusively on mouse feeder cells or adapted to human feeder cells.


At the same time, we continue to learn more about other types of stem
cells, including adult and those derived from umbilical cord blood.

· An NIH-supported researcher at the University of Minnesota isolated
multipotent adult progenitor cells from human bone marrow. These cells
demonstrate the potential to differentiate beyond bone marrow stem cells
into other cell types, including liver, neurons and blood vessels.

· In a laboratory of the National Institute of Dental and Craniofacial
Research, NIH intramural scientists have recently characterized a
population of stem cells found in the dental pulp of deciduous, or
“baby”teeth. These stem cells have the potential to become cells
expressing molecular markers characteristic of dentin, bone, fat and
nerve cells and may provide an accessible source of stem cells to repair
damaged teeth, regenerate bone, and treat nerve injury or disease.

· Scientists established a number of years ago that umbilical cord stem
cells can repopulate the bone marrow of a small child. Umbilical stem
cells can be used today to treat certain childhood disorders such as
Fanconi's anemia. With the current technology, however, these cord blood
stem cells can only be harvested in small numbers, which limits their
clinical utility. We are seeking methods to expand these cells in the
laboratory to generate very large numbers of the cells needed for many
other clinical applications.

Human embryonic stem cell research is still in its nascent stages, and
there are many basic research studies that will be required before we can
begin to plan clinical trials. NIH is supporting preliminary research to
understand how to direct differentiation along specific pathways, to
establish techniques for isolating specific cell types, to control cell
proliferation, and to control interactions between the host immune system
and transplanted cells that might mediate graft rejection.

Research using hESCs offers the potential to inform us about the earliest
molecular and cellular processes that regulate normal development, and
provides a tool to discover how a cell is able to be both pluripotent and
indefinitely self-renewing. In addition, research using hESCs will help
the scientific community to understand the molecular signals that specify
differentiation into specific cell types, some of which may ultimately be
useful for cell-based treatment of disorders, such as Type 1 diabetes or
Parkinson’s disease, that involve loss of a specific cell type.

As we continue our work with the research community to fund new research
and facilitate the availability of additional stem cell lines, the NIH
Stem Cell Task Force is continuously and vigorously evaluating the state
of the science to lead the implementation of a vigorous research program
envisioned by the President. Attaining basic knowledge about the
characteristics and potential use of stem cells remains the immediate
challenge before the research community today. Until we understand the
basics, we cannot know with certainty the future research requirements
for advancing into clinical trials using embryonic stem cells. The NIH
will continue to monitor the state of the science and assimilate the body
of research evidence in order to make informed, evidence-based
recommendations on this important issue.

We are working hard to promote stem cell research, based on
recommendations received from the research community by the NIH Stem Cell
Task Force. The newest effort is the establishment of the NIH
Characterization Unit, located on our campus in Bethesda, Maryland. This
unit will provide reliable and standardized data derived from assays
performed on human embryonic stem cell lines available for shipment to
the research community. The unit will provide a direct side-by-side
comparison to be made among the cell lines, and will facilitate
comparison with adult stem cells. These data will be publicly available
and will arm the scientific community with state-of-the-art information,
so scientists can make an informed choice when ordering one or more of
the available cell lines.

In response to additional recommendations from the research community, we
continue our efforts to recruit new scientists to the field, to help
mid-career investigators begin studies on embryonic stem cells, to
monitor the state-of-the science through the NIH Stem Cell Task Force, to
fund investigator-initiated grants, to disseminate information about the
science and initiatives via the NIH Stem Cell Task Force website and to
plan for a symposium that will bring together two hundred stem cell
researchers from all over the country and several foreign universities.

Again, I want to assure the committee of NIH’s commitment to pursuing
embryonic stem cell research, as well as continuing our advances in the
field of adult stem cell research. The President’s policy has provided us
the opportunity to be at the forefront of the latest groundbreaking
discoveries in the culturing, characterization and differentiation of
stem cells, and I am confident that NIH will keep its premier place in
this field for years to come.

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