Aastrom Biosciences' Tissue Repair Cells Used in New Clinical Trial for Regeneration of Vascular Tissue in Diabetic Patients
October 06 2005 - 5:45AM
PR Newswire (US)
-- Novel Treatment Utilizes Company's Adult Bone Marrow Stem Cell
Product -- ANN ARBOR, Mich., Oct. 6 /PRNewswire-FirstCall/ --
Aastrom Biosciences, Inc. (NASDAQ:ASTM) announced today that the
first clinical trial utilizing Aastrom's proprietary Tissue Repair
Cells (TRCs) to treat limb ischemia in diabetic patients has been
initiated at the Diabetes Center at the Heart and Diabetes Center
North Rhine-Westphalia (Diabetes Center) located in Bad Oeynhausen,
Germany. Initiation of the trial followed the Diabetes Center's
receipt of the licenses and the Investigational Medicinal Product
Dossier (IMPD) necessary to manufacture and use cells for clinical
trials in compliance with the new European Union directives. The
Bad Oeynhausen study is a collaborative effort between Aastrom and
the Diabetes Center. The principal investigator is Prof. Dr.
Diethelm Tschope, Director of the Diabetes Center. Senior Physician
Dr. P. Minartz, Dr. D. Lammers and Dr. rer. nat. B. Stratmann,
members of the Diabetes Center, will serve as the Study Management
Committee. The aim of this human study is to evaluate the safety
and ability of Aastrom's bone marrow-derived TRCs to regenerate
functioning blood vessels in the legs of diabetic patients with
limb ischemia. It is intended that the patients may experience
relief from clinical problems that are related to a loss of blood
circulation, such as: deep "bed-sore type" ulcerated wounds of the
feet, pain (or "claudication"), immobility, and infection. Diabetic
non- healing, infected ulcers often lead to the amputation of the
leg. Successful vascular regeneration may either delay or render
such amputation unnecessary. Standard of care treatments offer
limited relief and are usually restricted to wound management and
antibiotic treatment of the infected ulcers, in combination with
surgical interventions such as the implant of stents with vascular
by-pass or skin grafting. "The initiation of this trial is an
important step in our business strategy to use our TRC cell
products for multiple medical indications. We are extending our
clinical evaluations of the ability of these powerful cells to
regenerate not only blood and bone but now, vascular tissue," said
R. Douglas Armstrong, Ph.D., Chief Executive Officer and Chairman
of Aastrom. "The first phase of this study is intended to establish
the safety of our TRCs in this application, and to evaluate their
benefit to diabetic patients who have limited therapeutic options,
and who may face eventual limb amputation." It is expected that the
first phase of the trial will be completed in approximately 12
months. All patients to be enrolled in the trial have been
diagnosed with diabetes mellitus with ischemia-induced chronic
tissue ulcers in the lower limbs (known as angiopathic or
angioneuropathic diabetic foot syndrome), and are not suitable
candidates for operative or interventional revascularization.
Diabetics with such severe disease are the most difficult to treat
and evaluate. The design of this study includes control and
treatment groups. The effects of TRCs will be compared to those of
fresh, native bone marrow (active control), and to standard of care
procedures. Two different routes of administration of the cells
will be evaluated, with treatment patients receiving either direct
injection into the ischemic limb at multiple sites, or a single
intra-arterial injection above the affected tissue location.
Initially, the trial will enroll 5 patients into each of the
groups. The first set of data will be evaluated; based on this
data, improvements and amendments to the protocol are expected to
be introduced for the remaining patients. Over the 12 months
following treatment, the trial will evaluate whether the TRC
treatment results in improved or complete healing of the ulcers, as
well as whether amputation can be avoided or delayed. The trial
will also monitor the time to relapse if complete wound healing is
not attained, and whether the prognosis for patient survival
improves, compared to standard of care controls. About Diabetes
Center at the Heart and Diabetes Center North Rhine- Westphalia The
Diabetes Center at the Heart and Diabetes Center North Rhine-
Westphalia is a world-leading institution in the fields of cardiac,
circulatory and metabolic diseases located in Bad Oeynhausen,
Germany, offering both comprehensive diagnostics and treatment
under one roof. The Heart and Diabetes Center NRW is the University
Hospital of the Ruhr University of Bochum, Germany. 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 manufactured in the
AastromReplicell(R) System, an industry- unique automated cell
production system. 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,"
"intended," "expected," "can," 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 Cameron Associates Becky Anderson Kevin McGrath - Institutions
Investor Relations Department Phone: (212) 245-4577 Aastrom
Biosciences, Inc. Alyson Nikulicz - Media Phone: (734) 930-5777
Phone: (212) 554-5464 DATASOURCE: Aastrom Biosciences, Inc.
CONTACT: Kris M. Maly or Becky Anderson, both of Investor Relations
Department of Aastrom Biosciences, Inc., +1-734-930-5777; or Kevin
McGrath - Institutions, +1-212-245-4577, or Alyson Nikulicz -
Media, +1-212-554-5464 both of Cameron Associates for Aastrom
Biosciences, Inc. Web site: http://www.aastrom.com/
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