First Patient Treated in Aastrom Adult Stem Cell Trial for Critical
Limb Ischemia
Five Sites Initiated for Phase IIb Trial in U.S.
ANN ARBOR, Mich., June 27, 2007 (PRIME NEWSWIRE) -- Aastrom
Biosciences, Inc. (Nasdaq:ASTM)
today announced that the first critical limb ischemia (CLI) patient
was treated at the Malcom Randall Veterans Affairs (VA) Medical
Center in Gainesville, FL. The Company is evaluating its Vascular
Repair Cell (VRC) product in a U.S. Phase IIb clinical trial to treat
patients suffering from CLI, the most severe form of peripheral
arterial disease (PAD).
Approximately 900,000 people suffer from CLI, which leads to 100,000
major amputations per year in the U.S. CLI patients endure chronic
ischemia-induced pain (even at rest), ulcers, tissue loss or gangrene
in the limbs, and represent the end stage for PAD patients.
"Current surgical or endovascular techniques for limb
revascularizations are often limited by anatomic constraints in
patients with CLI. These patients suffer from rest pain and
frequently have no other options for revascularization. Typically we
see these patients over the course of several years. They come to us
with severe pain, and on evaluation typically have long segments of
their arteries blocked so that it is impossible for us to reestablish
blood flow by any conventional means. Unfortunately, these patients
often go on to develop gangrene of the toes, requiring successive
amputation surgery. Due to inadequate perfusion, the wounds from
these surgeries often do not heal, leading to a vicious cycle of
repeat amputations with wound healing complications,
A. Berceli, M.D., Ph.D., Principal Investigator at the VA Medical
Center. "The ability to improve blood flow to the limbs in patients
such as this through vascular tissue regeneration provides the next
generation of therapeutic options, and VRCs stand at the forefront of
these approaches."
Aastrom's VRCs are based on the Company's Tissue Repair Cell
Technology, which enables patient-specific stem cell products for
multiple regenerative medicine applications. Aastrom manufactures
VRCs for vascular tissue regeneration in an automated, GMP (Good
Manufacturing Practices) process. Unique in the stem cell industry is
the Company's manufacturing technology that enables the production of
a consistent and reliable cell product containing large numbers of
early stage stem and progenitor cells essential for tissue
regeneration.
"Our VRCs are composed of stem and progenitor cells that we believe
are required for tissue regeneration in the human body. A normal dose
of VRCs contains significantly more of these key cells than can
normally be harvested from a patient," stated Elmar R. Burchardt,
M.D., Ph.D., Vice President, Medical Affairs of Aastrom. "These large
numbers of stem and progenitor cells may be extremely important when
treating critical limb ischemia patients with severely impaired blood
flow that can affect the majority of their lower leg."
In addition to the VA Medical Center in Gainesville, FL, four other
sites have been initiated and trained, including: Southern Illinois
University School of Medicine, Springfield, IL; St. Joseph Mercy
Hospital, Ann Arbor, MI; Michigan Vascular Research Center, Flint,
MI; and, Vanderbilt University Medical Center, Nashville, TN. Aastrom
will update its website as other clinical sites are initiated and
trained.
Aastrom's prospective, controlled, randomized, double-blinded, multi-
center trial is expected to enroll 120 patients at up to 20 sites,
randomized into two patient groups, to evaluate the safety and
efficacy of the TRC-based product in the treatment of CLI. Patients
from both groups will be followed for a period of 12 months, post-
treatment. The primary objective of the clinical trial is to assess
the safety of the TRC-based product in CLI patients. Secondary
objectives include assessing amputation rates, wound closure and
blood flow in the affected limbs, patient quality of life, and the
reduction of pain and analgesic use. Once the first 30 patients have
completed the 12-month follow-up, Aastrom will analyze the interim
results from these patients. Data gathered from this clinical trial
will provide the scientific and statistical basis for an anticipated
pivotal trial in the vascular regeneration area.
About Aastrom Biosciences, Inc.
Aastrom is a regenerative medicine company developing autologous cell
products for the repair or regeneration of multiple human tissues,
based on its proprietary Tissue Repair Cell (TRC) Technology.
Aastrom's TRC-based products are a unique cell mixture of stem and
progenitor cells, produced from a small amount of bone marrow taken
from the patient. TRC-based products have been used in over 250
patients, and are currently in clinical trials for bone regeneration
(osteonecrosis of the femoral head and long bone fractures) and
vascular regeneration (critical limb ischemia applications)
Company is also developing programs to address cardiac and neural
regeneration indications. TRC-based products have received Orphan
Drug Designation from the FDA for use in the treatment of
osteonecrosis of the femoral head and the treatment of dilated
cardiomyopathy, a severe chronic disease of the heart.
The Aastrom Biosciences, Inc. logo is available at
http://www.primenew
For more information, visit Aastrom's website at www.aastrom.
(astmc)
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 "expected," "can," "anticipated,
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 patient accrual difficulties, 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.
CONTACT: Aastrom Biosciences, Inc.
Investor Relations Department
Kris M. Maly
(734) 930-5777
Cameron Associates
Kevin McGrath
(212) 245-4577
Media
Deanne Eagle
(212) 554-5463
http://www.primenew
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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