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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/