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Aastrom Biosciences, Inc.

Aastrom Biosciences Announces Initiation of Clinical Trial for Sinus Lift Bone Graft Procedures in Spain

Ann Arbor, Michigan (ots/PRNewswire)

- Aastrom's Proprietary TRCs to be Utilized to Build New Bone
Tissue for Dental Implants --
Aastrom Biosciences, Inc. (NasdaqSC: ASTM), and the Institut de
Terapia Regenerativa Tissular (ITRT) announced today that they have
initiated patient enrollment in a clinical trial with Instituto de
Cirugia Maxilofacial e Implantologia in Barcelona, Spain to determine
the safety and efficacy of Aastrom's proprietary Tissue Repair Cells
(TRCs) in maxillary sinus lift bone graft procedures necessary for
dental implants. The study is being conducted at Centro Medico Teknon
under the direction of Principal Investigator, Dr. Federico
Hernandez-Alfaro.
The trial will target regions in the upper (maxillary) jaw where
premature tooth loss has thinned the bone to such an extent that
surgery for tooth replacement cannot be effectively completed. To
address this clinical problem, this new study will evaluate the
ability of TRCs to regenerate and thicken the maxillary sinus bone
needed for a dental implant post. Dental implant surgery can improve
function and dental aesthetics in patients suffering from tooth loss.
In the initial phase of this trial, five patients will be accrued to
compare the outcome of the innovative Aastrom TRC treatment procedure
with that of a standard therapy.
This is the fourth clinical trial initiated by Aastrom to evaluate
the safety and ability of the Company's TRC technology to generate
local bone tissue. The three previously announced studies focus on
the use of TRCs to regenerate bone in severe long bone non-union
fractures that had previously failed to heal with conventional
therapies. One of the development objectives intended for TRCs is to
provide an effective way for surgeons to generate or repair local
bone tissue for any bone type, including long bones, spine and facial
bones. If this can be achieved, Aastrom's TRC products may serve as
an alternative to autograft, the invasive and painful procedure of
surgically carving out bone tissue from the hip.
"With four proof-of-concept feasibility clinical trials now
underway, we are diligently working to demonstrate the full value
that our TRC technology can bring to the generation of local bone
tissue," said R. Douglas Armstrong, Ph.D., Chairman and Chief
Executive Officer of Aastrom. "I am proud that our team here at
Aastrom has been able to effectively implement these different
studies, which should establish our strategic position in these major
market areas. We are excited to work in collaboration with Dr.
Hernandez-Alfaro and his clinical team on a highly innovative therapy
that has the potential to represent a breakthrough in maxillofacial
bone repair."
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 and
their expected results, 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," "may," "potential," "should,"
"can," 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 the
uncertainties of 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                    Kevin McGrath
     Becky Anderson                     Cameron Associates
     Investor Relations Department      Phone: +1-(212)-245-4577
     Aastrom Biosciences, Inc.
     Phone: +1-(734)-930-5777
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; FCMN Contact:
susanladue@arccommunications.com

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