GLOBENEWSWIRE
Compassionate Use Patients in Spain Treated With Adult Stem Cell Therapy Demonstrate Jaw Bone Regeneration Enabling Dental Implants
Compassionate Use Patients in Spain Treated With Adult Stem Cell Therapy
Demonstrate Jaw Bone Regeneration Enabling Dental Implants
Results From Three Patient Treatments Involving Investigational Stem Cell Therapy
Developed by Aastrom Biosciences Presented During the 2nd Annual Congress of
Regenerative Medicine & Stem Cell in Dalian, China
ANN ARBOR, Mich., Aug 10, 2009 (GlobeNewswire via COMTEX) -- Aastrom Biosciences,
Inc. (ASTM), a leading regenerative medicine company, today announced that
results from compassionate use treatments using Aastrom's Bone Repair Cells
(BRCs) in patients suffering from severe craniofacial defects were presented at
the 2nd Annual Congress of Regenerative Medicine & Stem Cell in Dalian, China.
BRCs are derived from a small sample of the patient's bone marrow that is
processed using Aastrom's proprietary Tissue Repair Cell (TRC) technology to
generate larger numbers of stem and early progenitor cells with enhanced
therapeutic potential.
In an oral presentation, Dr. Jose Mendonca, Director of the Head and Neck Surgery
Unit of Hospital POLUSA in Lugo, Spain and previously a Clinical and Research
Fellow in Oral and Maxillofacial Surgery at the UCLA School of Dentistry,
reviewed the results of treatment with BRCs in three patients with craniofacial
defects, as follows:
* The first patient was treated for severe mandibular
osteoradionecrosis, or osteonecrosis of the jaw caused by
radiation, and presented with pathological fracture and complete
numbness of the lower lip.At 12 months post-BRC treatment, the
patient displayed restored vascular function, new bone formation,
fracture consolidation and total recovery of lip numbness.
* The second patient was treated for post-traumatic mandibular
osteomyelitis and presented with massive bone loss, chronic
infection, chronic pain and total impairment of function of both
mandibular nerves.At 12 months post-BRC treatment, the patient
experienced complete functional nerve recovery and the formation of
new bone.
* The third patient was treated for iatrogenic massive bone loss in
the posterior maxilla and presented with severe oral function
impairment.At 12 months post-BRC treatment, the patient had new
bone formation in atrophic areas.
* All patients underwent a minor surgery to insert a dental implant
into the newly regenerated jaw bone.Eight weeks later, the dental
prosthesis (teeth) was attached to the implant completing the
treatment objectives with the restoration of oral function.
"The outcome of these treatments with BRCs has been very satisfactory. We
observed early bone formation in the afflicted areas that eventually resulted in
complete healing," said Dr. Mendonca. "Unexpected therapeutic results from
treatment with BRCs include peripheral nerve regeneration or repair, new skin
formation and proliferation in blood vessels in ischemic areas. The results open
a promising pathway for the treatment of some patients where conventional
therapies fail or do not exist."
Compassionate use of TRC-based products was authorized by the Spanish Ministry of
Health. In May 2008, Aastrom announced the reprioritization of its clinical
development programs to focus primarily on cardiovascular applications, thus
discontinuing further patient enrollment into the U.S. Phase III ON-CORE bone
regeneration clinical trial. The Company does not anticipate new clinical bone
activity or reactivating the Phase III ON-CORE trial at the present time but has
continued to treat patients on a compassionate use basis in Spain.
"Our bone program remains open for partnering. Encouraging compassionate use
treatments such as those noted by Dr. Mendonca strengthen our bone program
portfolio, especially in the EU," said Sheldon A. ********, PhD, Aastrom's Vice
President, Corporate Development & Intellectual Property.
At a parallel meeting, Francisco Vidal, Managing Director of Aastrom Biosciences
S.L., presented a summary overview of Aastrom's technology at the 2009 4th
Medical Biotech Forum in Dalian, China.
About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the repair
or regeneration of human tissue. The Company's proprietary Tissue Repair Cell
(TRC) technology involves the use of a patient's own cells to manufacture
products to treat a range of chronic diseases and serious injuries. Aastrom's
TRC-based products contain increased numbers of stem and early progenitor cells,
produced from a small amount of bone marrow collected from the patient. The TRC
technology platform has positioned Aastrom to advance multiple products into
clinical development. TRC-based products have been used in over 325 patients with
over 10 years of positive safety data. The Company's ongoing development
activities focus on applying TRC technology to cardiac and vascular tissue
regeneration. The Company is currently focused on cardiovascular regeneration
through a Phase II clinical trial with dilated cardiomyopathy (DCM) patients (the
IMPACT-DCM trial) and a Phase IIb clinical trial with critical limb ischemia
(CLI) patients (the RESTORE-CLI trial).
For more information, visit Aastrom's website at Aastrom Biosciences, Inc. -.
The Aastrom Biosciences, Inc. logo is available at
GlobeNewswire, Inc.
This document contains forward-looking statements, including without limitation,
statements concerning planned clinical trials and activities and anticipated
timing of clinical events, 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,"
"anticipated," "planned," 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.
This news release was distributed by GlobeNewswire, GlobeNewswire | Press Release Distribution | EDGAR Filings | Video News Releases
SOURCE: Aastrom Biosciences, Inc.
Aastrom Biosciences, Inc.
Kris M. Maly
Kimberli O'Meara
(734) 930-5777
Cameron & Associates
Investors
Kevin McGrath
(212) 245-4577
Berry & Company
Media
Stephen Zoegall
(212) 253-8881
(C) Copyright 2009 GlobeNewswire, Inc. All rights reserved.