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Aastrom Biosciences, Inc.

Aastrom Biosciences Announces Plans to Expand Bone Graft Study Based on Results of Severe Fracture Treatments

Ann Arbor, Michigan (ots/PRNewswire)

Aastrom Biosciences, Inc.
(NasdaqSC: ASTM) and the Institut de Terapia Regenerativa Tissular
(ITRT) announced today that their clinical trial in Barcelona, Spain
will be expanded based on initial results from the first phase of
patient treatments. The trial involved 5 patient treatments using
Aastrom's Tissue Repair Cells (TRCs) for the bone graft repair of
severe long bone non-union fractures, and was completed at the
Hospital General de l'Hospitalet, Centro Medico Teknon and Hospital
de Barcelona-SCIAS. The results to date show that Aastrom's TRCs were
safe, with no adverse events reported, and that patients are
exhibiting various early stages of healing. Aastrom will continue
monitoring the progressive bone regeneration in these patients, while
expanding the trial to include additional patients and formalizing a
plan for the registration of its TRC product for use in bone graft
surgery in the EU.
This trial, one of three clinical studies of Aastrom's bone graft
TRC product currently underway, was initiated in March 2004 in
cooperation with ITRT (Barcelona, SP), who coordinated the trial
implementation. This proof of concept feasibility clinical trial was
designed to evaluate the safety and effectiveness of the Company's
TRCs to regenerate new, healthy bone in the repair of long bone
non-union fractures. All of the patients who received TRC treatment
had previously failed to repair their non-union fractures using
standard of care procedures, during the preceding 6 to 16 months. The
results to date are interim, as complete bone fusion typically takes
many months.
The trial was completed under the direction of Principal
Investigators, Dr. Carlos Solano-Puerta and Dr. Lluis Orozco. These
physicians reported that each patient is exhibiting increased
mobility and freedom from pain as a result of the healing process at
the fracture site. Non-union fractures often present problems related
to their repair due to the severity of the fracture in which the bone
pieces are completely separated. This type of fracture usually
requires various mechanical fixations and bone graft processes for
repair. However, standard procedures may fail, requiring the patients
to undergo additional surgery and bone grafting approaches. This was
the situation for all of the patients in the Barcelona trial, who
having failed to heal their fractures after standard of care
treatments, received TRCs mixed with a synthetic commercial matrix,
directly at the fracture site.
Dr. Lluis Orozco, Scientific Director of ITRT, commented on the
study, "We are very satisfied with the results that we have seen in
these first five patient treatments, and with the process, utilizing
Aastrom's Tissue Repair Cell technology. We are motivated to now
expand the trial to treat additional patients with this new adult
stem cell-based approach. We believe the potential ability of TRCs to
eliminate the standard surgical process of autograft bone chip
collection would offer a better procedure for our patients."
"Completing these first 5 patient treatments, and observing
positive safety and patient progress are very important milestones
for the Company, and we believe represent the first such results in
the clinic using an ex vivo-produced bone marrow stem cell product,"
said R. Douglas Armstrong, Ph.D., Chairman and Chief Executive
Officer of Aastrom. "While additional clinical data must be collected
in continued trials of our TRC product to provide conclusive
evidence, we are confident that this data is sufficient proof of
concept for the Company to aggressively pursue the clinical trials
and activities needed for EU product registration."
Typical bone grafting procedures are used to repair major
fractures of legs and arms, as well as to reconstruct bone in the jaw
and to fuse spine vertebrae. The long-time standard treatment
procedure, called autograft, involves surgically chiseling out bone
chips and marrow from the patient's hip to obtain the necessary
quantities of bone graft material. This process generally results in
substantial acute and chronic pain and complications at the hip
collection site. In an attempt to eliminate this clinical problem,
various bone matrix substitutes have been developed and are sometimes
used as an alternative to autograft procedures. These alternatives
are not as effective because bone matrix substitutes lack the
cellular components needed to generate bone. In this study, Aastrom's
TRCs, which have been shown to contain large numbers of adult stem
and other cells needed to generate bone, are combined with a
synthetic matrix product, and applied directly at the fracture site.
The application of TRCs is intended to form an optimized bone graft,
without the after effects of the autograft procedure.
About Tissue Repair Cells
Tissue Repair Cells (TRCs) are Aastrom's proprietary mixture of
bone marrow stem and progenitor cells produced using patented
single-pass perfusion technology in the AastromReplicell(R) System.
The clinical procedure begins with the collection of a small sample
of bone marrow from the patient's hip in an outpatient setting. TRCs
are then produced in the automated AastromReplicell System over a
12-day period. It has been demonstrated in the laboratory that TRCs
are able to develop into different types of tissue lineages in
response to inductive signals, including blood, bone, cartilage,
adipose and vascular tubules. In previous clinical trials, TRCs have
been shown to be safe and reliable in regenerating certain normal
healthy bone marrow tissues.
About Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc. (NasdaqSC: ASTM) is a regenerative
medicine company developing proprietary adult stem cell-based
products for the repair or generation of damaged human tissues and
other medical disorders. Aastrom's strategic position in the tissue
regeneration and cell therapy sectors is enabled by its proprietary
Tissue Repair Cells (TRCs), a mix of bone marrow stem and progenitor
cells, and the AastromReplicell(R) System, an industry-unique
automated cell production platform used to produce cells for clinical
use. Together TRCs and the AastromReplicell System provide a
foundation that the Company is leveraging to produce multiple
Prescription Cell Products (PCPs), the first of which is now in the
clinical stage in the U.S. and EU. TRCs are the core component of the
PCPs Aastrom is developing for bone grafting, peripheral vascular
disease, jaw bone reconstruction and spine fusion markets. The
Company has also developed the AastromReplicell System for dendritic
cell production for researchers and institutions developing vaccines
to treat cancer and infectious diseases, under its Cell Production
Products line.
For more information, visit Aastrom's website at
http://www.aastrom.com.
This document contains forward-looking statements, including
without limitation, statements concerning planned clinical trials,
product development objectives, potential product applications, and
potential advantages of the AastromReplicell(R) System, which involve
certain risks and uncertainties. The forward-looking statements are
also identified through use of the words "intended," "plan,"
"potential," "believe," 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 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.
CONTACTS:
    Kris M. Maly or
    Becky Anderson
    Investor Relations Department
    Aastrom Biosciences, Inc.
    Phone: +1-(734)-930-5777
    Kevin McGrath
    Cameron Associates
    Phone: +1-(212)-245-4577
Web site:  http://www.aastrom.com

Contact:

Kris M. Maly or Becky Anderson, Investor Relations Department of
Aastrom Biosciences, Inc., +1-734-930-5777; or Kevin McGrath of
Cameron Associates, +1-212-245-4577