Aastrom Biosciences Expands Bone Graft Clinical Trial to Include University Of Michigan
30 June 2004 - 11:00PM
PR Newswire (US)
Aastrom Biosciences Expands Bone Graft Clinical Trial to Include
University Of Michigan -- Enrollment Open for Repair of Severe Leg
Fractures at Orthopedic Trauma CenterUsing Company's Adult Stem
Cell Product -- ANN ARBOR, Mich., June 30 /PRNewswire-FirstCall/ --
Aastrom Biosciences, Inc. (NASDAQ:ASTM) today announced that its
lead U.S. clinical trial of the Company's bone generation Tissue
Repair Cell (TRC) adult stem cell product has been initiated at a
second site, the University of Michigan Health System (UMHS) in Ann
Arbor. The trial, to be conducted at UMHS's orthopedic trauma
center, opens for patient enrollment on the heels of the previously
announced site at Lutheran General Hospital in Park Ridge, IL,
outside Chicago. Both sites are included under the clinical trial
protocol for the Company's FDA- approved Investigational New Drug
(IND). Aastrom is also actively engaged in similar clinical trials
of its bone graft product in Germany and Spain. The Principal
Investigator at this new clinical site is James A. Goulet, M.D.,
Professor, Orthopedic Trauma and Joint Reconstruction, at the
University of Michigan Health System. Dr. Goulet has practiced
orthopedic surgery at UMHS for over 17 years. He is the author or
co-author of more than 100 publications in medical journals, and is
a member of the American Academy of Orthopedic Surgeons, the
Orthopedic Trauma Association and the Michigan Orthopedic Society,
among others. Dr. Goulet lectures frequently on the subject of bone
fracture repair and management, and has conducted numerous
grant-supported studies in this area. Under the provisions of the
IND for this U.S. clinical trial, as many as 20 patients can be
treated who have either long-term (a minimum of 8 months)
non-healing tibial leg fractures, or tibial non-union fractures
that are severe enough to require a bone graft to aid repair. The
IND allows up to three centers to participate. "The initiation of a
second U.S. site in this bone graft trial represents further
progress for our stem cell-based TRCs for tissue generation, and
our goal of bringing this product into standard medical practice,"
said R. Douglas Armstrong, Ph.D., President, Chief Executive
Officer and Chairman of Aastrom. "We are pleased to collaborate
with Dr. Goulet, who is highly respected in the orthopedic
community, and the University of Michigan, a leading healthcare
institution. This orthopedic trauma referral center services a
large number of patients and therefore should provide immediate
access to patients targeted for this study. With this center in
place, and continued supportive results from our active clinical
sites, we expect to add a third U.S. center for our bone grafting
clinical trial." Aastrom's active clinical trials of its bone graft
product for large bone fractures are currently underway in the
United States, Germany and Spain. Although the specific protocols
for each trial vary, the goal of all three trials is to demonstrate
the safety, feasibility and efficacy of Aastrom's bone generation
stem cell product. The patients in the clinical studies will be
followed for 12 to 24 months, post surgery, depending on the
individual site protocol. All three trials are enrolling patients,
and will proceed based on the pace of accrual. The time that must
elapse before investigators can identify initial results will vary
from patient to patient, and begins when the mixture of Aastrom's
TRCs and a matrix are surgically applied at the fracture site.
About Stem Cells Stem cells are human cells that have the
capability to form multiple, or in some cases, all types of
tissues. Therefore, stem cells represent potentially powerful
agents for repairing damaged or diseased tissues. Stem cells are
found in every individual's bone marrow; access is simple and
without controversy. Stem cells are also found in embryonic tissues
as part of a developing fetus, but access to these cells has proven
controversial. As a result, researchers seeking potential novel
treatments for a wide variety of diseases and disorders are
increasingly investigating bone marrow-derived "adult stem cells"
in clinical research. Aastrom's stem cell therapeutics program uses
adult stem cells, typically derived from the patient's own bone
marrow, which can be successfully grown to the increased number of
cells required for certain clinical applications, using the
patented technology embodied in the AastromReplicell(R) System.
About Aastrom Biosciences, Inc. Aastrom Biosciences, Inc.
(NASDAQ:ASTM) is developing proprietary stem cell-based products
for the regenerative repair 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 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, the first of which is
now in the clinical stage in the U.S. and EU. TRCs are the core
component of the Prescription Cell Products Aastrom is developing
for the bone grafting, peripheral vascular disease and cartilage
markets. The Company also markets the AastromReplicell System and
disposable dendritic cell production kits to 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, and potential product applications,
which involve certain risks and uncertainties. The forward-looking
statements are also identified through use of the words "intended,"
"expect," "can," "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 patient accrual rates, future
clinical trial results, regulatory approval requirements, 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.
CONTACTS: Kris M. Maly or Becky Anderson Investor Relations
Department Aastrom Biosciences, Inc. Phone: (734) 930-5777 Kevin
McGrath Cameron Associates Phone: (212) 245-4577 DATASOURCE:
Aastrom Biosciences, Inc. CONTACT: Kris M. Maly or Becky Anderson,
Investor Relations Department, Aastrom Biosciences, Inc.,
+1-734-930-5777; or Kevin McGrath, Cameron Associates,
+1-212-245-4577 Web site: http://www.aastrom.com/
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