Aastrom Biosciences Reports Positive Human Jaw Bone Reconstruction Results from Feasibility Clinical Trial
December 21 2005 - 5:45AM
PR Newswire (US)
-- Results Indicate Company's Tissue Repair Cell Product Safely
Builds New Bone for Dental Implants -- ANN ARBOR, Mich., Dec. 21
/PRNewswire-FirstCall/ -- Aastrom Biosciences, Inc. (NASDAQ:ASTM)
announced today the interim results from its feasibility clinical
trial conducted with the Teknon Hospital Maxillofacial Clinic in
Barcelona, Spain, to evaluate the use of Aastrom's Tissue Repair
Cells (TRCs) for maxillary (upper jaw) bone reconstruction in 5
patients, completed to support placement of dental implants. The
study results showed clinical safety, and that the TRC treatment
sites all exhibited bone growth that was statistically significant
and had the desired initial integration with preexisting bone. An
internal report of the clinical study, which provides more detailed
information, is being filed today on Form 8-K with the SEC. This
report may also be accessed on Aastrom's website using the link:
http://www.aastrom.com/pdf/Jaw_Barcelona-051220.pdf. The goal of
this proof of concept, internally controlled clinical trial was to
evaluate the safety and ability of TRCs -- a proprietary autologous
bone marrow-derived stem cell product -- to increase bone height in
the posterior maxilla (upper jaw) of 5 patients, who had severe
bone loss in the region and minimal residual bone remaining. The
patients were judged to have a poor prognosis with previously lost
teeth due to periodontal disease and tooth decay, and additional
risk factors that are known to compromise bone regeneration and
preservation. These risk factors included many years of smoking,
osteoporosis and advanced age. The intent of the TRC therapy was to
help rebuild healthy bone so that there was enough bone to
accommodate the length of the dental implants. A standard bone
graft technique was used as an internal concurrent control on the
other side of the maxilla. All of the primary outcomes described by
the trial protocol were successfully achieved. Results showed that
all 5 patients treated locally with Aastrom's TRCs, exhibited a
statistically significant increase in bone height at the 3-month
evaluation point, and the cell graft had started to integrate with
the surrounding preexisting bone of the upper jaw by 4 months, with
no cell-related adverse events. The results were obtained from
radiographs, and from biopsies taken at the interface of the
original bone and the new tissue. All patients went on to receive
3-4 dental implants on each side of their maxilla. The study
employed an internal concurrent control, in which the patients were
treated on one side of the maxilla with the TRC test treatment
added to a standard of care procedure, and on the other side with
the control standard of care procedure, a mixture of platelet-poor
plasma and commercial bone mineral matrix. There was a
statistically significant difference in bone formation and quality
between test and control sides. Bone height in the grafted area and
integration of graft into surrounding bone were increased in the
TRC test maxilla, when compared with control sites receiving
standard of care treatment. Post-operative bruising and swelling
observed at some (3/5) of the control sites, were not observed in
the TRC treated maxillae (0/5). This is the second clinical bone
graft trial to report that surgical sites treated with TRCs appear
to exhibit less inflammation or swelling than sites treated without
TRCs. "Edentulous patients who have lost this much jaw bone can be
very difficult to treat," commented Dr. Federico Hernandez-Alfaro,
Principal Investigator for the trial. "TRCs may offer an improved
treatment over existing therapies because they appear to naturally
accelerate integration of new bone with the existing bone in the
patient, and increase bone mass for implant placement." "Results
such as these provide increasing evidence that TRCs can be safely
used to regenerate bone in humans whose ability to maintain and
repair their skeleton is impaired by disease or trauma," stated
Janet M. Hock, B.D.S., Ph.D., Vice President Global Research and
Chief Scientific Officer of Aastrom. "These early clinical studies
explore tissue healing and regeneration in patients with
compromised conditions, and teach us what to expect from stem cell
therapy, and how to optimize the use of TRCs in clinical
situations." Aastrom is implementing a "proof of concept" clinical
plan to evaluate the ability of TRCs to generate three different
types of bone: long bone, jaw bone and spine. Trials involving
multiple centers in both the U.S. and Europe are actively
evaluating TRCs in the repair of severe non-union fractures, where
preliminary results have demonstrated both safety and bone growth
success. A trial for the regeneration of spine bone (vertebral
fusion) has been initiated in the U.S. under a newly approved IND.
In addition, the Company is now engaged in a human clinical trial
in Germany evaluating the use of its TRCs to treat limb ischemia in
diabetic patients through the regeneration of vascular tissue in
extremities. 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. is developing patient-specific products
for the repair or regeneration of human tissues, utilizing the
Company's proprietary adult stem cell technology. Aastrom's
proprietary Tissue Repair Cells (TRCs), a mix of bone
marrow-derived adult stem and progenitor cells for tissue
regeneration, are manufactured in the AastromReplicell(R) System,
an industry- unique automated cell production system. Aastrom's TRC
cell products are in clinical trials for the following therapeutic
indications: severe bone fractures (US: Phase I/II - multi-center;
EU: Phase I/II - multi-center), ischemic vascular disease (EU:
Phase I/II), jaw reconstruction (EU: proof of concept trial), and
spine fusion (US: Phase I/II - single-center). For more
information, visit Aastrom's website at http://www.aastrom.com/.
This document contains forward-looking statements, including
without limitation, statements concerning product development
objectives, planned clinical trials, potential advantages of TRCs
and the AastromReplicell(R) System, and potential product
applications, which involve certain risks and uncertainties. The
forward-looking statements are also identified through use of the
words "may," "expect," "can," "plan," "appear," 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 product
development difficulties, clinical trial results, potential patient
accrual 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, 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 Web site:
http://www.aastrom.com/
http://www.aastrom.com/pdf/Jaw_Barcelona-051220.pdf
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