What is Stem Cell: June 2008

Monday, June 30, 2008

[StemCells] ALS, Cord Blood, University of S. Florida

(Students, you may want to go to University of S. Florida - they keep
reporting great therapeutic results.)

ALS: UMBILICAL CORD BLOOD CELL TRANSPLANTS MAY HELP PATIENTS
Transplants of mononuclear human umbilical cord blood cells may help
patients suffering from Amyotrophic Lateral Sclerosis, also known as
Lou Gehrig's disease, according to researchers at the University of
South Florida. In results published at PloS ONE, researchers
determined that the moderate-strength dose of human umbilical cord
blood cells was most effective in increasing lifespan and reducing
disease progression in mice. ALS is a disease in which the motor
neurons in the spinal cord and brain degenerate, leaving its victims
with progressive muscle weakness, paralysis and, finally, respiratory
failure three to five years after diagnosis. Researchers said
modulating immune and inflammatory effectors with human umbilical
cord blood cells could have a protective effect on dying motor
neurons. The team had previously shown that human umbilical cord
blood cell transplants reduced inflammation and provided
neuroprotection in models of stroke and Alzheimer's disease.

http://www.tjols.com/weekly_brief-2-272.html#als

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StemCells subscribers may also be interested in these sites:

Children's Neurobiological Solutions
http://www.CNSfoundation.org/

Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123

The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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Thursday, June 26, 2008

[StemCells] qPCR NEWS June 2008 - Update in RNA integrity

qPCR NEWS June 2008 - Update in RNA integrity

Dear researcher,
dear Gene Quantification page reader,

Our newsletter informs about the latest news in quantitative real-time
PCR (qPCR and qRT-PCR), which are compiled and summarised on the Gene
Quantification homepage. The focus of this newsletter issue is:

- RNA integrity page updated!
- CAmpER - Real-time PCR analysis software
- Event calendar 2008
- qPCR meetings 2008
- qPCR application workshops

----------------------------------------------------------
If this newsletter is not displayed correctly by your email client,
please use following link:
http://qPCRnews.gene-quantification.info/
----------------------------------------------------------

RNA Quality control The assessment of RNA integrity is a critical ﬁrst
step in obtaining meaningful gene expression data. Working with
low-quality RNA may strongly compromise the experimental results of
downstream applications which are often labour-intensive,
time-consuming, and highly expensive. Using intact and integer RNA is
a key element for the successful application of modern molecular
biological methods, like qRT-PCR or micro-array analysis. To verify
RNA quality nowadays commercially available automated
capillary-electrophoresis systems are available which are on the way
to become the standard in RNA quality assessment. Proﬁles generated
yield information on RNA concentration, allow a visual inspection of
RNA integrity, and generate approximated ratios between the mass of
ribosomal sub-units.

More info here: http://RNA-integrity.gene-quantification.info/

----------------------------------------------------------

Updated publications - RNA Quality control

Impact of RNA quality on reference gene expression stability.
Claudina Angela Pérez-Novo, Cindy Claeys, Frank Speleman, Paul Van
Cauwenberge, Claus Bachert, and Jo Vandesompele
BioTechniques 2005 Volume 39, Number 1: pp 52-56

Improved RNA quality and TaqMan® Pre-amplification method (PreAmp) to
enhance expression analysis from formalin fixed paraffin embedded
(FFPE) materials.
Li J, Smyth P, Cahill S, Denning K, Flavin R, Aherne S, Pirotta M,
Guenther SM, O'Leary JJ, Sheils O.
BMC Biotechnol. 2008 8:10.

Optimization of the PAXgene blood RNA extraction system for gene
expression analysis of clinical samples.
Chai V, Vassilakos A, Lee Y, Wright JA, Young AH.
J Clin Lab Anal. 2005;19(5): 182-188.

Successful downstream application of the Paxgene Blood RNA system from
small blood samples in paediatric patients for quantitative PCR analysis.
Carrol ED, Salway F, Pepper SD, Saunders E, Mankhambo LA, Ollier WE,
Hart CA, Day P.
BMC Immunol. 2007 8:20.

Impact of RNA degradation on gene expression profiles: assessment of
different methods to reliably determine RNA quality.
Copois V, Bibeau F, Bascoul-Mollevi C, Salvetat N, Chalbos P, Bareil
C, Candeil L, Fraslon C, Conseiller E, Granci V, Mazière P, Kramar A,
Ychou M, Pau B, Martineau P, Molina F, Del Rio M.
J Biotechnol. 2007 127(4): 549-559.

REVIEW: RNA integrity and the effect on the real-time qRT-PCR
performance.
Simone Fleige & Michael W. Pfaffl
Molecular Aspects of Medicine 27 (2006) 126–139

Successful RNA extraction from various human postmortem tissues.
Heinrich M, Matt K, Lutz-Bonengel S, Schmidt U.
Int J Legal Med. 2007 121(2): 136-142.

RNA quality in frozen breast cancer samples and the influence on gene
expression analysis – a comparison of three evaluation methods using
microcapillary electrophoresis traces.
Strand C, Enell J, Hedenfalk I, Fernö M.
BMC Mol Biol. 2007 8: 38.

Preanalytical mRNA stabilization of whole bone marrow samples.
Langebrake C, Günther K, Lauber J, Reinhardt D.
Clin Chem. 2007 53(4): 587-593.

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With the new qPCR INFO PORTAL and all the presented tools we will help
you with to find the right information about qPCR and related topics
in Molecular Biology in the literature and in the World Wide Web.
=> Papers / Protocols / Methods / Databases / Alets / Feeds / Books /
Forums / E-mail / Directory

http://infoportal.gene-quantification.info/

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CAmpER - Real-time PCR analysis software

CAmpER - Calculation of Amplification Efficiencies for RT-PCR
experiments is a tool for the automatic analysis of real time PCR
experiments.

http://www.gene-quantification.de/download.html#camper

Automatic analysis, annotation and storage of real-time PCR
experiments performed with different real-time PCR systems, currently
the LightCycler® and the Opticon®.

----------------------------------------------------------

Upcoming Events World-wide academic and commercial qPCR Events
http://events.gene-quantification.info/

Symposia, Meetings, Conferences, Workshops, Seminars, Online-Seminars,
qPCR Education Program, ...etc..
Please submit your qPCR event here => events@gene-quantification.info

----------------------------------------------------------

qPCR SYMPOSIUM BENELUX

The prominent and still growing place taken by real-time quantitative
PCR in applied and fundamental research and clinical diagnostics
almost appears obvious. However, it is clear that contributions made
by various scientists and companies in the field during the last
decade rendered this technology useful and affordable for many users.

More info => http://www.gene-quantification.de/meetings.html#benelux

Importantly, the qPCR domain is still in constant evolution, making it
sometimes hard to stay informed about new methodological approaches or
original studies using the real-time PCR. Therefore, we have scheduled
a one day "Benelux qPCR Symposium" on October 6th 2008, giving the
opportunity to the scientific community to get informed and discuss
various aspects of real-time PCR (including but not limited to new
applications, assay optimization and validation, new technologies,
etc.). Scientific talks, posters sessions and industrial booths will
be at the menu.

Download poster =>
http://www.gene-quantification.de/qpcr_benelux_poster.pdf

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qPCR Symposium USA
10. - 13. November 2008
Clarion Hotel San Francisco Airport, Millbrae, CA , USA

More info => http://www.gene-quantification.de/meetings.html#qpcr_usa

- High throughput platforms: High throughput applications, real-time
RT-PCR arrays, digital PCR
- Forthcoming technologies: Immuno PCR, Methylation sensitive PCR,
SNP analysis, High resolution melt, microRNA detection, - Multiplex
technologies
- Single-cell qPCR: Pre-amplification techniques, sub-cellular PCR,
Expression heterogeneity, laser microdissection, FACS sorting,
Enrichment of rare cells
- Multimarker diagnostics: Disease markers, Tissue specific markers,
Cancer markers, Stem cells, Differentiation markers, Cancer stem cells
- Real-time PCR Expression Profiling: multivariate and multiway
expression profiling, temporal expression profiling, spatiotemporal maps
- Pre-analytical Steps: Sampling technologies, Extraction methods,
Reverse Transcription, Quality Control, Standards, Standard Operating
Procedures, Interlaboratory Exercises
- Normalization & Standardization: Normalization strategies,
Reference genes, Spikes, Standard curves, multiplexing, inter-run
calibrators, quantification strategies, mRNA degradation
- Data management and data treatment: software applications, data
mining, data visualization, biostatistics, multivariate statistics

----------------------------------------------------------

qPCR WORKSHOP

TATAA Biocenter Germany - qPCR Application workshops

At the TATAA Biocenter Germany we offer qPCR application workshops,
the 3-day Core Module and a 2-day Biostatistics Module. qPCR courses
are held in regularly in Göteborg, Sweden, in English and in
Freising-Weihenstephan, Germany, in German and English, and in Prague,
Czech Republic in English and Czech.
Depending on the occasion the workshop language and the different
prices may apply. Further customized workshops and specialized
trainings will be held as well across Europe and world-wide. TATAA
Biocenter Germany courses are held in cooperation with the Institute
of Physiology, located at the Technical University of Munich, in
Freising-Weihenstephan, near Munich, very close to the Munich Airport
(MUC). For more information and to register for the qPCR application
workshops, please see our web page:
http://tataa.gene-quantification.info/

Course Occasions 2008:
3-day qPCR Core Module (Mon. - Wed.) and 2-day BioStatistics
Module (Thu. - Fri.)

* 7 - 11th July 2008 (in Freising, Germany, English language)
* 15 - 19th September 2008 (in Freising, Germany, English language)
* 13 - 17 October 2008 (in Freising, Germany, Kurs wird in DEUTSCH
gehalten, German language)
* 24 - 28th November 2008 (in Freising, Germany, English language)

Please register here => http://www.tataa.com/Courses/Courses.html

----------------------------------------------------------

Forward Please send the qPCR NEWS to further scientists and friends
who are interested in qPCR !

Best regards,

Michael W. Pfaffl
responsible Editor of the Gene Quantification Pages
http://www.gene-quantification.info

----------------------------------------------------------

If this newsletter is not displayed correctly by your email client,
please use following link:
http://qpcrnews.gene-quantification.info/

The qPCR NEWS and the Gene Quantification Pages are educational sites
with the only purpose of facilitating access to qPCR related
information on the internet. The qPCR NEWS and the Gene
Quantification Pages are edited by Michael W. Pfaffl and powered by
BioScience Events. Copyright © 2005 - 2008 All rights reserved. Any
unauthorized use, reproduction, or transfer of this message or its
contents, in any medium, is strictly prohibited. Disclaimer &
Copyrights are displayed on the homepage www.gene-quantification.com
To subscribe or change your e-mail address in qPCR NEWS, and if you
would like to receive future issues FREE of charge, please send an
e-mail with the subject SUBSCRIBE to
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Sunday, June 22, 2008

[StemCells] ASC regulators identified

Stem cells replace damaged mouse tissue
by MT Bureau - June 18, 2008 - 0 comments
Berkeley, Calif. -- U.S. scientists say they have successfully used
stem cells to repair and replace damaged tissue in mice.

The University of California-Berkeley bioengineers say their
achievement sets the path for research on new treatments for age-
related degenerative conditions such as muscle atrophy or Alzheimer's
and Parkinson's diseases.

The scientists identified two key regulatory pathways that control
how well adult stem cells repair and replace damaged tissue. They
then tweaked how those stem cells reacted to biochemical signals to
revive the ability of muscle tissue in old mice to repair itself
nearly as well as the muscle in much younger mice.

Assistant Professor Irina Conboy who led the research said because
the findings relate to adult stem cells that reside in existing
tissue, the approach to rejuvenating degenerating muscle eliminates
the ethical and medical complications associated with transplanting
tissues grown from embryonic stem cells.

"We are one step closer to having a point of intervention where we
can rejuvenate the body's own stem cells so we don't have to suffer
from some of the debilitating diseases associated with aging," said
Morgan Carlson, the study's lead author.

The findings are reported in the online edition of the journal Nature.

Copyright 2008 by United Press International.
http://www.themoneytimes.com/news/20080617/stem_cells_replace_damaged_
mouse_tissue-id-1026393.html

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[StemCells] Maturing Nerve SCs

Molecule That Nudges Nerve Stem Cells To Mature Created By UT
Southwestern Researchers
17 Jun 2008 - 2:00 PDT

Inspired by a chance discovery during another experiment, researchers
at UT Southwestern Medical Center have created a small molecule that
stimulates nerve stem cells to begin maturing into nerve cells in
culture.

This finding might someday allow a person's own nerve stem cells to
be grown outside the body, stimulated into maturity, and then re-
implanted as working nerve cells to treat various diseases, the
researchers said.

"This provides a critical starting point for neuro-regenerative
medicine and brain cancer chemotherapy," said Dr. Jenny Hsieh,
assistant professor of molecular biology and senior author of the
paper, which appears online and in the June 17 issue of Nature
Chemical Biology.

The creation of the molecule allowed the researchers to uncover some
of the biochemical steps that happen as nerve cells mature. It also
showed that large-scale screening of compounds can provide starting
points for developing drugs to treat disorders such as Huntington's
disease, traumatic brain injury or cancer.

The scientists began this project as a result of a separate study in
which they were screening 147,000 compounds to see which could
stimulate stem cells cultivated from rodent embryos to become heart
cells. Unexpectedly, five molecules stimulated the cells to transform
into forms resembling nerve cells. The researchers then created a
variation of these molecules, a new compound called Isx-9 (for
isoxazole-9). Isx-9 was easier to use than its initially discovered
relatives because it worked at a much lower concentration and also
dissolved more easily in water.

"It was completely serendipitous that we uncovered this neurogenic
[nerve-creating] small molecule," Dr. Hsieh said. "I think it's one
of the most powerful neurogenic small molecules on the planet. In
theory, this molecule could provoke full maturation, to the point
that the new nerve cells could fire, generating the electrical
signals needed for full functioning."

Nerve stem cells live in scattered groups in various areas of the
brain. They are capable of becoming several different types of cells,
not all of which are nerve cells.

In the study, rodent nerve stem cells from an area of the brain
called the hippocampus were cultured with Isx-9. They clustered
together and developed spiky appendages called neurites, which
typically happens when nerve cells are grown in culture.

Isx-9 also prevented the stem cells from developing into non-nerve
cells and was more potent than other neurogenic substances in
stimulating nerve-cell development. The molecule generated two to
three times more nerve cells than other commonly used compounds.

Neuroscientists believed for decades that the adult mammalian brain
could not grow new nerve cells. Instead, they thought, learning and
memory were strictly a matter of the brain making new connections
between existing cells.

It is now known, however, that the brain constantly creates new nerve
cells. In the hippocampus, which is involved with learning and
memory, stem cells mature into full-blown nerve cells at a rate of
thousands a day, Dr. Hsieh said.

Scientists know that when a mature nerve cell sends a chemical signal
called a neurotransmitter to a stem cell, the immature cell begins to
mature, but they don't know what biochemical pathways or genes are
involved, Dr. Hsieh said.

"The big gap in our knowledge is how to control these stem cells,"
she said.

Isx-9 appeared to act like a neurotransmitter-like signal on the
nerve stem cells, the researchers found. By culturing the stem cells
with the compound, the scientists identified a possible biochemical
pathway by which stem cells begin to become nerve cells.

The researchers next plan to test Isx-9 on a large number of
different combinations of RNA, the chemical cousin of DNA, to see on
which genes the compound might be working. They have also applied for
a patent on Isx-9 and its relatives.

----------------------------
Article adapted by Medical News Today from original press release.
----------------------------

Other UT Southwestern researchers involved in the study were Dr. Jay
Schneider, assistant professor of internal medicine; Dr. Zhengliang
Gao, postdoctoral researcher in molecular biology; Dr. Shijie Li,
postdoctoral researcher in molecular genetics; Midhat Farooqi, a
student in the Medical Scientist Training Program; Dr. Tie-Shan Tang,
instructor of physiology; Dr. Ilya Bezprozvanny, professor of
physiology; and Dr. Douglas Frantz, assistant professor of
biochemistry.

The work was supported by the Haberecht Wild-Hare Idea Program, the
Donald W. Reynolds Foundation, the National Institute of Neurological
Disorders and Stroke, the Ellison Medical Foundation, the Welch
Foundation and the UT Southwestern President's Research Council.

Dr. Jenny Hsieh

Source: Aline McKenzie
UT Southwestern Medical Center
http://www.medicalnewstoday.com/articles/111512.php

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[StemCells] Lung SC activation

Penn researchers find key developmental pathway activates lung stem
cells
Pathway could hold promise for lung tissue repair
PHILADELPHIA – Researchers from the University of Pennsylvania School
of Medicine found that the activation of a molecular pathway
important in stem cell and developmental biology leads to an increase
in lung stem cells. Harnessing this knowledge could help develop
therapies for lung-tissue repair after injury or disease. The
investigators published their findings online last week in advance of
print publication in Nature Genetics.

"The current findings show that increased activity of the Wnt pathway
leads to expansion of a type of lung stem cell called
bronchioalveolar stem cells," says senior author Edward Morrisey,
Ph.D., Associate Professor of Medicine and Cell and Developmental
Biology.

"This information will give us a more extensive basic understanding
of Wnt signaling in adult tissue repair in the lung and other tissues
and also start to help us determine whether pharmacological
activation or inhibition of this pathway can be utilized for
treatments," explains Morrisey, who is also the Scientific Director
of the Penn Institute for Regenerative Medicine.

Activation of the Wnt signaling pathway leads to expansion, or
increase in number, of bronchioalveolar stem cells in the lung. A
protein called GATA6 inhibits Wnt signaling by directly regulating
the expression of another protein in the Wnt pathway called frizzled
2 (Fzd2).

Wnt signaling is a major pathway in stem cell biology. The finding
that GATA6 negatively regulates Wnt signaling and that GATA6 has been
shown to play important roles in embryonic stem cell replication and
differentiation suggests that these two pathways are linked not only
in lung stem cells but in other tissues where they play important
roles including the heart, gut, and pancreas.

"We were surprised by the robust activation of Wnt signaling after
loss of GATA6 expression in the lung," says Morrisey. "Such a robust
activation is rarely observed."

Wnt signaling can be pharmacologically modulated with compounds,
including lithium, already approved by the FDA. Use of such
compounds, both known and newly identified through ongoing screens,
could allow for forced expansion and differentiation of key stem cell
populations in the lung and other tissues for adult tissue repair
after injury or disease.

Future directions of the Morrisey lab include not only a more
extensive basic understanding of Wnt signaling in adult-tissue repair
in the lung and other tissues, but also starting to determine whether
pharmacological activation or inhibition of this pathway can really
be utilized for treatments.

###

Penn co-authors are Yuzhen Zhang, Ashley M. Goss, Ethan David Cohen,
Rachel Kadzik, John J. Lepore, Karthika Muthukumaraswamy. Jifu Yang,
and Michael Parmacek. This work was funded by the National Institutes
of Health.

PENN Medicine is a $3.5 billion enterprise dedicated to the related
missions of medical education, biomedical research, and excellence in
patient care. PENN Medicine consists of the University of
Pennsylvania School of Medicine (founded in 1765 as the nation's
first medical school) and the University of Pennsylvania Health
System.

Penn's School of Medicine is currently ranked #4 in the nation in
U.S.News & World Report's survey of top research-oriented medical
schools; and, according to most recent data from the National
Institutes of Health, received over $379 million in NIH research
funds in the 2006 fiscal year. Supporting 1,400 fulltime faculty and
700 students, the School of Medicine is recognized worldwide for its
superior education and training of the next generation of physician-
scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three
hospitals — its flagship hospital, the Hospital of the University of
Pennsylvania, rated one of the nation's "Honor Roll" hospitals by
U.S.News & World Report; Pennsylvania Hospital, the nation's first
hospital; and Penn Presbyterian Medical Center — a faculty practice
plan; a primary-care provider network; two multispecialty satellite
facilities; and home care and hospice.

Public release date: 17-Jun-2008
Contact: Karen Kreeger
karen.kreeger@uphs.upenn.edu
215-349-5658
University of Pennsylvania School of Medicine

http://www.eurekalert.org/pub_releases/2008-06/uops-prf061708.php

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[StemCells] SCs for Crohn's

Researchers to test stem cells to treat Crohn's
BY DELTHIA RICKS | delthia.ricks@newsday.com
June 18, 2008

Stem cells may force Crohn's disease into retreat, say Long Island
medical investigators who are embarking on a pioneering analysis that
targets patients who've failed other therapies.

Cases of Crohn's disease have skyrocketed since World War II, jumping
tenfold in the United States and raising questions about the
disease's genetics and demography. It is one of two disorders - the
other is ulcerative colitis - that are known as inflammatory bowel
diseases. Before the 20th century there was no recorded evidence of
either.

Dr. Robert Richards, director of clinical research in the
gastroenterology division at Stony Brook University Medical Center,
is embarking on a clinical study involving the infusion of adult stem
cells, which he and other researchers theorize may force the
condition into retreat. His analysis is part of a multicenter trial
nationwide, focusing on patients with moderate to severe forms of the
disease.

Patients had "basically tried all of the medications that are out
there for Crohn's and have not done well or have become intolerant to
[standard] treatment," Richards said.

The stem cells are drawn from the bone marrow of adult donors and
processed into an infusible preparation. Because stem cells are
essentially blank slates capable of morphing into any kind of cell,
researchers believe that when infused into the intestinal tract, they
will help remodel cells there and relieve symptoms.

Inflammation caused by Crohn's disease can occur anywhere along the
tract from the mouth to the anus. Symptoms may wax and wane but the
inflammation can lead to scarring, which dramatically disrupts
intestinal function. Some people are racked with painful diarrhea
tinged with blood.

Current therapies include anti-inflammatory drugs and antibiotics.
Additional treatments include those that quell the activity of
certain parts of the immune system. Among the theories explaining the
cause of Crohn's is that it is triggered by turncoat cells, so that
the body is at war with itself.

Two weeks ago the Food and Drug Administration announced an
investigation into three drugs that tamp down the immune system,
following 30 reports of children and young adults who developed
cancer.

Edda Ramsdell, executive director of Long Island's division of the
Crohn's and Colitis Foundation of America, said the stem cell
research could provide a new avenue. "This is exciting but there
probably isn't a single answer. People react differently to
treatments," she said.

Dr. R. Balfour Sartor of the University of North Carolina, scientific
adviser to the foundation, said it's always important to explore new
therapies, including stem cells. "I am frustrated by the lack of
current medical and even surgical cures of this disease," said
Sartor, who will speak next month on Long Island about his new
dietary theory.

Richards' stem cell study will run for a year. Patients will range
between 18 and 70.

CROHN'S DISEASE EXPLAINED

Crohn's tends to run in families, and susceptibility genes have been
identified. People of Ashkenazi Jewish descent have a higher
incidence compared with other ethnic groups. The disorder is not
especially prevalent among Sephardic Jews.

First described in 1930 by Dr. Burrill Crohn of Mt. Sinai Hospital in
Manhattan. Before the 20th century there was no recorded evidence of
Crohn's or ulcerative colitis, both inflammatory bowel diseases.
Generally, colitis is viewed as serious, but not as devastating as
Crohn's.

Crohn's is diagnosed more often in industrialized countries where
sugar consumption is very high, and less so in underdeveloped
countries, though scientists note an increase worldwide. Some
scientists think excessive sugar consumption may affect the
genetically susceptible to Crohn's by altering the balance of
bacteria that inhabit the intestinal tract.

Long Island is disproportionately affected by people with Crohn's
disease, based on genetics and demographics. The Crohn's and Colitis
Foundation of America estimates 30,000 Long Islanders have Crohn's
disease, or ulcerative colitis. Nationwide, more than 1 million
people have an inflammatory bowel disease.
http://www.newsday.com/news/printedition/longisland/ny-
licroh185731126jun18,0,4084105.story

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[StemCells] Aastrom Phase II Cardiac Repair - Marrow

Aastrom to Initiate Phase II Clinical Trial Using Cardiac Repair
Cells Derived From Patient's Own Bone Marrow for Treatment of Severe
Chronic Heart Failure
FDA Authorizes IND Application for Aastrom's First Cardiac
Regeneration Clinical Trial
ANN ARBOR, Mich., June 17, 2008 (PRIME NEWSWIRE) -- Aastrom
Biosciences, Inc. (Nasdaq:ASTM), a leading regenerative medicine
company, today announced plans to initiate a 40 patient U.S. Phase II
clinical trial to study the use of Cardiac Repair Cells (CRCs), a
mixture of stem and progenitor cells derived from a patient's own
bone marrow, for the treatment of dilated cardiomyopathy (DCM), a
severe form of chronic heart failure. Aastrom is now authorized under
U.S. Food & Drug Administration (FDA) regulations to initiate its
first Investigational New Drug (IND) clinical trial for cardiac
regeneration. CRCs, manufactured using Aastrom's Tissue Repair Cell
(TRC) technology, previously received Orphan Drug Designation from
the FDA for the treatment of DCM.

"This landmark trial is the first in the world to target both
ischemic and non-ischemic DCM patients. It is also the first trial in
the U.S. to evaluate the surgical delivery of autologous cells
directly into the source of the problem, the heart muscle, for the
treatment of congestive heart failure due to DCM," stated David A.
Bull, M.D., Professor of Surgery and Chief of Cardiothoracic Surgery
at the University of Utah School of Medicine. "Aastrom's unique
technology is able to produce a mixed cell population that we believe
may be efficacious for treating these end-stage patients and is our
primary motivation for participating in the trial."

The randomized, controlled, prospective, open-label, Phase II study
will seek to enroll 20 patients with ischemic DCM and 20 patients
with non-ischemic DCM at five clinical sites in the U.S. Participants
must have a left ventricular ejection fraction of less than or equal
to 25% (60-75% is typical for a healthy person) and meet certain
other eligibility criteria. All patients in each group will receive
standard medical care and 75% of the patients will be treated with
CRCs through direct injection into the heart muscle during open heart
surgery. While the primary objective of this study is to assess the
safety of CRCs in patients with DCM, efficacy measures including left
ventricular ejection fraction and other cardiac function parameters
as well as heart failure stage will be monitored. Patients will be
followed for 12 months post treatment.

"Aastrom's trial is targeting critically ill patients with heart
failure. These patients, with enlarged, weakened hearts, are at the
end-stage of their disease and currently have no treatment options
other than a heart transplant," said Mariell Jessup M.D., Professor
of Medicine and Medical Director of Heart Failure and
Transplantation, at the University of Pennsylvania Health
System. "Without a new therapeutic approach the majority of these
patients will continue to decline and less than 40% will survive five
years."

There are currently 5.5 million people in the U.S. suffering from
chronic heart failure. A subset of these patients has DCM, a chronic
cardiac disease where expansion of the patient's heart reduces the
pump function to a point that the normal circulation of blood cannot
be maintained. Patients with DCM typically present with symptoms of
congestive heart failure, including severe limitations in their
physical activity and shortness of breath. DCM generally occurs in
patients who have ischemic heart failure due to multiple heart
attacks, though it can also be found in patients with non-ischemic
heart failure caused by hypertension, viral infection or alcoholism.
Patient prognosis depends on the stage of the disease but is
characterized by numerous health problems and a very high mortality
rate.

"After initial positive patient experience in the EU, we are pleased
to be advancing our promising CRC program into the clinic in the
U.S.," said George Dunbar, President and Chief Executive Officer of
Aastrom. "The IND approval for a Phase II trial to treat patients
suffering from DCM supports our decision to focus our efforts and
resources primarily on cardiac regeneration. As we move our cardiac
development program forward, we will stop enrolling patients in our
ON-CORE clinical trial for bone regeneration until we identify a
partner to work with us to complete that effort. Patients who have
already been treated in the ON-CORE trial will be followed by their
physicians for the full 24 month follow-up period. Our RESTORE-CLI
clinical trial targeting critical limb ischemia will continue as
planned."

About Orphan Drug Designation

The Orphan Drug Designation is granted to development-stage products,
such as Aastrom's CRCs, that offer potential therapeutic value in the
treatment of rare diseases and conditions. The Company may be
entitled to several benefits prior to approval, including an
expedited FDA review, the reduction or even elimination of filing
fees, and the availability of possible tax credits, and will be
entitled to seven years of marketing exclusivity once the product
receives FDA approval.

About Aastrom Biosciences, Inc.

Aastrom is a leader in the development of autologous cell products
for the repair or regeneration of human tissue. The Company's
proprietary Tissue Repair Cell (TRC) technology involves the use of a
patient's own cells to manufacture products to treat a range of
chronic diseases and serious injuries affecting cardiovascular, bone
and neural tissues. Aastrom's TRC-based products contain increased
numbers of stem and early progenitor cells, produced from a small
amount of bone marrow collected from the patient. The TRC technology
platform has positioned Aastrom to advance multiple products into
clinical development. Currently, the Company has a cardiovascular
regeneration product in Phase II development for the treatment of
dilated cardiomyopathy (DCM) (called the IMPACT-DCM trial) and
critical limb ischemia (called the RESTORE-CLI trial), a bone
regeneration product in Phase III development for the treatment of
osteonecrosis of the femoral head (called the ON-CORE trial), and a
preclinical research program targeting unmet needs in neural health.
Aastrom product candidates to treat DCM and osteonecrosis of the
femoral head have been designated for orphan drug status by the FDA.
For more information, visit Aastrom's website at www.aastrom.com.
(astmc)

The Aastrom Biosciences, Inc. logo is available at
http://www.primenewswire.com/newsroom/prs/?pkgid=3663

This document contains forward-looking statements, including without
limitation, statements concerning clinical trial plans and
expectations, clinical activity timing, intended product development
and commercialization objectives, adequacy of existing capital to
support operations for a specified time, future capital needs, and
potential advantages and application of Tissue Repair Cell (TRC)
Technology, all of which involve certain risks and uncertainties.
These statements are often, but are not always, made through the use
of words or phrases such
as "anticipates," "intends," "estimates," "plans," "expects," "we
believe," "we intend," and similar words or phrases, or future or
conditional verbs such
as "will," "would," "should," "potential," "could," "may," or similar
expressions. Actual results may differ significantly from the
expectations contained in the forward-looking statements. Among the
factors that may result in differences are the inherent uncertainties
associated with clinical trial and product development activities,
regulatory approval requirements, competitive developments, and the
availability of resources and the allocation of resources among
different potential uses. These and other significant factors are
discussed in greater detail in Aastrom's Annual Report on Form 10-K
and other filings with the Securities and Exchange Commission.

CONTACT: Aastrom Biosciences, Inc.
Investor Relations Department
Kris M. Maly
(734) 930-5777

Berry & Company
Media
Stephen Zoegall
(212) 253-8881

Cameron & Associates
Investors
Kevin McGrath
(212) 245-4577

http://www.primenewswire.com/newsroom/news.html?d=144754

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