Aastrom Treats Patients In Adult Stem Cell Clinical Trial For Osteonecrosis

Aastrom
Biosciences, Inc. (Nasdaq: ASTM), a company focused on the use of
autologous cells for regenerative medicine, today announced that the first
two patients have been treated in a pivotal clinical trial utilizing the
Company's Tissue Repair Cells (TRCs) for the treatment of osteonecrosis
(also known as avascular necrosis) of the femoral head. The pivotal trial
sponsored by Aastrom is being conducted at Centro Medico Teknon (Teknon)
located in Barcelona, Spain. Aastrom initiated patient enrollment and
treatment after receiving written approval from the Spanish Drug Agency
(AEMPS) and Teknon's Ethics Committee for the Company's Investigational
Medicinal Product Dossier (IMPD).


"The initiation of this osteonecrosis clinical trial in Spain is an
integral step for our overall bone regeneration program," said George
Dunbar, Chief Executive Officer and President of Aastrom. "If successful,
the patient data from this pivotal trial will support future registration
applications submitted to the regulatory authorities in the EU, as well as
to the FDA in the U.S."



This is Aastrom's first pivotal study evaluating the Company's TRC stem
cell therapy in patients with osteonecrosis of the femoral head. Initially,
ten patients will be accrued into this trial at Teknon and treated by
Principal Investigator, Dr. Lluis Orozco and Co-Investigators, Dr. Robert
Soler-Rich and Dr. Carles Solano. In general terms, the expected treatment
approach will include the removal of the necrotic tissue from the interior
of the patient's femoral head (top of the femur), followed by the
implantation of TRCs. The expectation is that if the femoral head is
strengthened by the re- growth of healthy bone, marrow and vascular tissue,
the need for a hip replacement could be delayed or eliminated for patients
suffering from this disease. The primary efficacy endpoint of this trial is
to eliminate or delay the progression of osteonecrosis, which will be
measured by MRI and X-ray. Patients will be followed for a total of 24
months, post treatment.



"The experience we acquired using the TRC cell product in prior studies
of atrophic non-union long bone fractures gave us the confidence to apply
the TRC technology to patients with osteonecrosis. We hope to demonstrate
significant efficacy over existing therapies," said Dr. Llu?­s Orozco,
Scientific Director, Orthopedics, of Institut de Terapia Regenerativa
Tisular.



The tissues involved in the osteonecrosis disease process include bone,
bone marrow and blood vessels (vascular), complicating the development of
effective treatments in the past. Aastrom's TRCs, a proprietary mixture of
stem and progenitor cells derived from a small sample of the patient's own
bone marrow, have been used in separate clinical trials to regenerate all
three of these tissues. With this capability, TRCs may offer a novel means
to regenerate the tissues lost due to osteonecrosis.
















In 2006, Aastrom's proprietary TRCs received an Orphan Drug Designation
from the U.S. Food and Drug Administration (FDA) for use in the treatment
of osteonecrosis of the femoral head. Aastrom is preparing a protocol for a
U.S. pivotal osteonecrosis clinical trial with the FDA.



About Osteonecrosis



The National Osteonecrosis Foundation indicates that in the U.S. alone,
there are up to 20,000 new people diagnosed with this debilitating disease
each year, and current therapies are of limited effectiveness.
Osteonecrosis is a painful medical condition where the tissue inside a bone
is dying and unable to regenerate itself through natural processes. Ninety
percent of the patients afflicted by this disease have osteonecrosis at the
femoral head -- the ball at the top of the femur bone that rotates inside
the hip socket. Left untreated the femoral head eventually collapses,
leading to the requirement of a total hip joint replacement. In the U.S.,
it is estimated that up to 10% of all hip replacements are performed due to
osteonecrosis. There are no established pharmaceuticals for the prevention
or treatment of osteonecrosis. For more information, visit the National
Osteonecrosis Foundation's website at nonf.



About Aastrom Biosciences, Inc.



Aastrom Biosciences, Inc. is developing autologous cell products for
the repair or regeneration of multiple human tissues, based on its
proprietary Tissue Repair Cell (TRC) technology. Aastrom's TRC-based
products are a unique cell mixture containing stem and progenitor cell
populations, produced from a small amount of bone marrow taken from the
patient. TRC-based products have been used in over 230 patients, and are
currently in clinical trials for bone regeneration (osteonecrosis of the
femoral head, long bone fractures and spine fusion) and vascular
regeneration (critical limb ischemia) applications. Aastrom has reported
positive interim clinical trial results for TRCs suggesting both the
clinical safety and the ability of TRCs to promote healing in bone
regeneration applications. The Company is developing plans for TRC- based
therapies to address cardiac and neural regeneration indications.



For more information, visit Aastrom's website at aastrom.
(astmc)



This document contains forward-looking statements, including without
limitation, statements concerning planned clinical trials, product
development objectives, potential advantages of TRCs, and potential product
applications, which involve certain risks and uncertainties. The
forward-looking statements are also identified through use of the words
"expected," "should," and other words of similar meaning. Actual results
may differ significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are potential patient accrual difficulties, clinical trial
results, potential product development difficulties, the effects of
competitive therapies, regulatory approval requirements, the availability
of financial and other 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.


Aastrom Biosciences, Inc.

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