Aastrom Biosciences' U.S. Clinical Investigator to Report On Long Bone Fracture Repair Trial
22 March 2006 - 10:00PM
PR Newswire (US)
-- Positive Patient Treatment Results Presented at Combined
Orthopaedic Research Society and American Academy of Orthopaedic
Surgeons Meetings -- ANN ARBOR, Mich., March 22
/PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (NASDAQ:ASTM)
announced today that Matthew L. Jimenez, M.D. will present results
from his early clinical experience with the first seven patients
treated for recalcitrant long bone non-union fractures with
Aastrom's Tissue Repair Cells (TRCs). The presentation will be
delivered today as part of a symposium at the combined Orthopaedic
Research Society and American Academy of Orthopaedic Surgeons
meetings in Chicago, IL. Dr. Jimenez, of the Illinois Bone &
Joint Institute, Morton Grove, IL, is the Principal Investigator of
Aastrom's U.S. Phase I/II multi-center clinical trial evaluating
the use of TRCs -- a mixture of stem, stromal and progenitor cells
derived from the patient's bone marrow -- in the treatment of
severe fractures that have failed prior treatment interventions.
(Logo: http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO )
Dr. Jimenez will present a brief overview of the multi-center trial
that is currently underway, as well as the background and progress
of the first seven patients that he treated in the trial. The
results include data from the first 6 months of observation after
TRC grafting that was combined with surgical correction of
long-standing non-union fractures. The results noted in this U.S.
trial complement observations previously reported in Aastrom's
European feasibility study, showing positive bone regeneration with
no TRC- related adverse events. A copy of Dr. Jimenez' planned
presentation is being filed today on Form 8-K with the SEC. At that
time the presentation may be accessed on Aastrom's website using
the following link:
http://www.aastrom.com/pdf/MLJ-Presentation-032206.pdf. These seven
patients, treated at Lutheran General Hospital in Park Ridge, IL,
all had fractures of their tibia bone, which had failed to heal
after one to three (with a mean of two) prior standard of care bone
grafting and surgical treatments. Previous treatment approaches
included failures in internal and external fixation to align and
immobilize the fractured bone, autologous bone grafting and bone
morphogenetic protein (BMP) supplementation. The average period of
time from the initial fractures to TRC treatment was 12 months
(range 7 to 29 months). The TRC-treated patients, age 30-73 years,
underwent open reduction and internal fixation (ORIF) surgery in
which TRCs were applied directly at the fracture site, together
with an allograft bone matrix graft extender (provided by Aastrom's
partner in the study, the Musculoskeletal Transplant Foundation) to
promote local bone regeneration. Bone regeneration, evidenced by
callus formation or bone bridging, was observed in radiographs for
all seven patients by 6 months. Early healing was seen in four of
the patients by 3 months after treatment with TRCs. Post-surgical
evaluations of these patients using standard clinical and
radiographic evaluations of the healing fracture site will continue
over a 12 month period. The multi-center trial is accruing up to a
total of 36 patients. "I am encouraged by the healing of these very
difficult to treat fractures in these first few patients. The use
of an autologous bone marrow-derived tissue product as an
innovative cell therapy has the potential to provide a valuable
alternative to some of the most difficult orthopedic challenges in
trauma," commented Matthew L. Jimenez, M.D. "We, and the other
clinical sites in this study, will continue to accrue and treat
patients with this novel TRC product." This multi-center trial
protocol is approved at the following treatment centers: Lutheran
General Hospital, Park Ridge, IL; the University of Michigan Health
System, Ann Arbor, MI; William Beaumont Hospital, Royal Oak, MI;
Lutheran Medical Center, Brooklyn, NY; and, University of Nebraska
Medical Center, Omaha, NE. "These early pilot data are most
encouraging, especially given the poor prognosis of these patients
who had failed standard-of-care treatments. We are adding to our
knowledge the use of TRCs with different formulations of bone
gap-filling materials. These results in patients using allograft
matrix complement our European studies which tested TRCs with
synthetic ceramic matrices," stated Janet M. Hock, B.D.S., Ph.D.,
Vice President Global Research and Chief Scientific Officer of
Aastrom. "While these data are very promising, we will maintain
caution in interpreting the results of our U.S. trial of non-union
fractures until the full set of 36 patients at the five sites is
completed." About Tissue Repair Cells Tissue Repair Cells (TRCs)
are Aastrom's proprietary mixture of bone marrow-derived adult
stem, stromal 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 hematopoietic
(blood and immune systems), mesenchymal (connective tissues such as
bone), adipose, and endothelial (vascular tubules). In clinical
trials, TRCs have been shown to be safe in over 200 patients. About
Aastrom Biosciences, Inc. Aastrom Biosciences, Inc. (NASDAQ:ASTM)
is developing products for the repair or regeneration of multiple
human tissues, based on its proprietary Tissue Repair Cell (TRC)
adult stem cell technology. Aastrom's TRC products contain large
numbers of stem, stromal and progenitor cells that are produced
from a small amount of bone marrow cells originating from the
patient. The AastromReplicell(R) System, an industry-unique
automated cell product manufacturing platform, was developed for
the production of standardized, patient-specific TRC products. TRC
products have been used safely in humans as a substitute for bone
marrow stem cells, and are currently in clinical trials for bone
grafting (long bone fractures and spine fusion) and blood vessel
regeneration (diabetic limb ischemia) applications. The Company has
recently reported positive interim clinical trial results for its
TRCs demonstrating both the clinical safety and ability of TRCs to
induce healthy new tissue growth (long bone fractures and jaw bone
reconstruction). For more information, visit Aastrom's website at
http://www.aastrom.com/. This document contains forward-looking
statements, including without limitation, statements concerning
product development objectives, planned clinical trials, potential
advantages of TRCs and the AastromReplicell(R) System, and
potential product applications, which involve certain risks and
uncertainties. The forward-looking statements are also identified
through use of the words "may," "planned," "potential," 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
product development difficulties, clinical trial results, potential
patient accrual 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 Cameron Associates Investor Relations Department Kevin
McGrath Aastrom Biosciences, Inc. Phone: (212) 245-4577 Phone:
(734) 930-5777
http://www.newscom.com/cgi-bin/prnh/20060302/NETH028LOGO
http://photoarchive.ap.org/ DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly, Investor Relations of Aastrom Biosciences,
Inc., +1-734-930-5777; or Kevin McGrath of Cameron Associates,
+1-212-245-4577 Web site: http://www.aastrom.com/
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