Aastrom Biosciences Expands U.S. Bone Graft Clinical Trial To Include University of Nebraska Medical Center
July 21 2005 - 8:00AM
PR Newswire (US)
Aastrom Biosciences Expands U.S. Bone Graft Clinical Trial To
Include University of Nebraska Medical Center - UNMC is 5th Site
Open to Patient Enrollment for the Repair of Severe Leg Fractures
Using Aastrom's Proprietary TRCs - ANN ARBOR, Mich., July 21
/PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (NASDAQ:ASTM)
announced today that it has expanded the U.S. Phase I/II clinical
trial of its adult stem cell-based Tissue Repair Cells (TRCs) in
the treatment of severe long bone open or non-union fractures to
include the University of Nebraska Medical Center (UNMC) in Omaha,
NE. This is the fifth site now engaged in this U.S. multi-center
trial, which is already underway at Lutheran General Hospital, Park
Ridge, IL, the University of Michigan Health System, Ann Arbor, MI,
William Beaumont Hospital, Royal Oak, MI, and Lutheran Medical
Center, Brooklyn, NY. The Principal Investigator for this site is
Matthew A. Mormino, M.D. Dr. Mormino is an Associate Professor and
Residency Program Director for the Department of Orthopaedic
Surgery and Rehabilitation at the University of Nebraska Medical
Center in Omaha, Nebraska. Edward V. Fehringer, M.D. will join Dr.
Mormino as co-investigator for this trial. Patients wishing to
participate in the trial may contact Connie Feschuk, RN, Research
Coordinator, at the University of Nebraska Medical Center, (402)
559-4167, or Principal Investigators at any of the other sites.
"This study explores the osteogenesis aspect of bone formation. We
intend to establish the ability of adult bone marrow-derived stem
and progenitor cells to function as bone forming cells to promote
fracture healing in adversarial situations such as open and/or
established non-union fractures," said Dr. Mormino. "If this trial
proves successful, this procedure will provide an effective
alternative to current bone grafting procedures, which are often
very painful." Patients suffering with either long-term,
non-healing, or appendicular (fresh) non-union tibial fractures may
be eligible to enroll in this study. The clinical procedure begins
with the collection of a sample of bone marrow from the patient's
hip in an outpatient setting. The adult stem cells (unspecialized
cells) and progenitor cells (partially specialized cells) derived
from the bone marrow are placed in the AastromReplicell(R) System
where TRCs are produced over a 12-day period. These TRCs are then
inserted back into the patient at the fracture site, in an
operating room procedure. These cells are designed to act as bone
forming cells and promote healing of the open or non-union
fractures. About Department of Orthopaedic Surgery and
Rehabilitation, University of Nebraska Medical Center The
Department of Orthopaedic Surgery and Rehabilitation at the
University of Nebraska Medical Center is part of a Level 1 Trauma
Center. Its physicians provide quality, comprehensive orthopaedic
care, and continue to be active in many areas of research. Areas of
research currently being explored include outcomes in total joint
arthroplasty, minimally invasive surgery in total joint
replacement, rotator cuff disease, and whiplash associated
disorders in coordination with gait analysis. The department has
two laboratory facilities: a Biomechanics Laboratory directed by
Hani Haider, Ph.D., and a Nano-Biotechnology Laboratory directed by
Fereydoon Namavar, Sc.D., which greatly complement its research
efforts. UNMC is the only public health science center in the
state. Its educational programs are responsible for training more
health professionals practicing in Nebraska than any other
institution. Through its commitment to education, research, patient
care and outreach, UNMC has established itself as one of the
country's leading centers in cancer, transplantation biology,
bioterrorism preparedness, neurodegenerative diseases,
cardiovascular diseases, genetics, biomedical technology,
ophthalmology and arthritis. UNMC's research funding from external
sources is now more than $76 million annually and has resulted in
the creation of more than 2,400 highly skilled jobs in the state.
About Tissue Repair Cells Tissue Repair Cells (TRCs) are Aastrom's
proprietary mixture of bone marrow-derived adult 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. (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
planned clinical trials, product development objectives, potential
advantages of TRCs, and potential product applications, which
involve certain risks and uncertainties. The forward-looking
statements are also identified through use of the words "may,"
"intend," 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. CONTACTS: Kris M. Maly or Becky
Anderson Cameron Associates Investor Relations Department Kevin
McGrath - Institutions Aastrom Biosciences, Inc. Phone: (212)
245-4577 Phone: (734) 930-5777 Alyson Nikulicz - Media Phone: (212)
554-5464 DATASOURCE: Aastrom Biosciences, Inc. CONTACT: Kris M.
Maly or Becky Anderson, Investor Relations Department, Aastrom
Biosciences, Inc., 734-930-5777; or Cameron Associates, Kevin
McGrath - Institutions, 212-245-4577, or Alyson Nikulicz - Media,
212-554-5464 Web site: http://www.aastrom.com/
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