Aastrom Biosciences Issues Statement on Unique Features of its Bone Marrow Tissue Repair Cell Product and Technology
27 April 2005 - 5:24AM
PR Newswire (US)
Aastrom Biosciences Issues Statement on Unique Features of its Bone
Marrow Tissue Repair Cell Product and Technology -- The Following
is a Statement from R. Douglas Armstrong, Ph.D., Chief Executive
Officer and Chairman of Aastrom Biosciences, Inc. Regarding Recent
Article in New Scientist Magazine -- ANN ARBOR, Mich., April 26
/PRNewswire-FirstCall/ -- R. Douglas Armstrong, Ph.D., Chief
Executive Officer and Chairman of Aastrom Biosciences, Inc.
(NASDAQ:ASTM) today issued the following statement in response to
an article concerning certain aging, research laboratory cultured
mesenchymal stem cells and their potential ability to produce
tumors in animals, published in the April 21, 2005 edition of New
Scientist magazine. The report noted that mesenchymal stem cells
can be managed safely using standard cell culture expansion for 6-8
weeks. However, following multi- passage long-term culture (4 to 5
months), these cells could undergo a spontaneous transformation to
cells that may form tumors. This long term culture effect has been
known for animal cells, and is now shown for human cells as well.
Aastrom is developing patient-specific bone marrow-based products
-- called "Tissue Repair Cells" or TRCs -- for the repair or
regeneration of human tissues, utilizing the Company's proprietary
technology. The Aastrom TRC production process utilizes a small
amount of the patient's own bone marrow, the natural habitat for
stem cells in the human body. The sample is placed in a sterile
cassette inside the AastromReplicell(R) System, a proprietary,
automated cell production system designed to mimic the natural
tissue growth environment of the human body. In a short 12-day
production cycle the bone marrow grows, filling the cassette and
resulting in a much higher number of early-stage stem and
progenitor cells, which are then harvested and administered back to
the patient for therapeutic treatment. There are a number of
important differences that distinguish Aastrom's TRCs from the
cells that were discussed in the New Scientist article, which
synopsized the results of studies cited in an original article in
Cancer Research, Vol. 65, Pgs. 3035-3039, published April 15, 2005.
The experiments discussed in the original article used cells
obtained from adipose tissue, or fat, not from bone marrow. Once
the adipose tissue was collected, the investigators selectively
isolated a specific type of cell, removing it from its native
tissue environment and thereby eliminating the growth controls that
the tissue environment provides. The long-term culture approach
used by the investigators was a multiple-passage process that can
be preferential for selective outgrowth of transformed cells that
can form tumors. Finally, the resultant human cells were
administered to mice, a pre- clinical laboratory model which does
not always allow for a normal human tissue growth opportunity. In
contrast, Aastrom's TRCs are produced in a natural mixed-cell
environment, in which the bone marrow stem cells remain associated
with a portion of the native tissue environment. TRCs are produced
over a very short, defined period of 12 days utilizing Aastrom's
proprietary single-pass perfusion technology, which maintains
conditions that are conducive to a natural bone marrow growth
process. The 12-day process is much less than the 6 to 8 week
process that was shown to be safe in the Cancer Research study.
TRCs are not an isolated, pure stem cell product, but a mixture of
cells found naturally occurring in bone marrow, and include stem
and other cells, which is the natural mixture for augmenting tissue
growth. Also, because TRCs are derived from the patient being
treated, there are no rejection issues. Aastrom's TRCs have been
administered safely to over 180 patients to date with no evidence
of tumorigenic activity or other serious issues. Aastrom is
currently conducting an FDA-approved multi-center human clinical
trial of its lead product, intended for the repair of severe long
bone fractures, in the United States, and is engaged in similar
trials of this lead product in the EU. About Aastrom Biosciences,
Inc. Aastrom Biosciences, Inc. (NASDAQ:ASTM) is developing
patient-specific products for the repair or regeneration of human
tissues, utilizing the Company's proprietary adult stem cell
technology. Aastrom's strategic position in the tissue regeneration
sector is enabled by its proprietary Tissue Repair Cells (TRCs), a
mix of bone marrow-derived adult stem and progenitor cells, and the
AastromReplicell(R) System, an industry-unique automated cell
production platform used to produce cells for clinical use. TRCs
are the core component of the products Aastrom is developing for
severe bone fractures, ischemic vascular disease, jaw
reconstruction and spine fusion, with Phase I/II level clinical
trials active in the U.S. and EU for some of these indications. 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, 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 word "plan," 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, 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: (212) 245-4577 Aastrom Biosciences, Inc. Phone: (734)
930-5777 DATASOURCE: Aastrom Biosciences, Inc. 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 Web site: http://www.aastrom.com/
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