BioTissue Technologies AG
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New therapeutic possibilities in the treatment of osteoarthritis
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New therapeutic possibilities in the treatment of osteoarthritis
First clinical data on BioSeed-C autologous
3-dimensional chondrocyte graft
Freiburg, 10th February 2003 – BioTissue Technologies AG is publishing the first
clinical data on BioSeed-C autologous 3-dimensional chondrocyte graft. The
results show:
– Demonstrable filling of the cartilage defects already in the early phase
– Improvement of the disorders and the patients’ quality of life
– Clear shortening of the time for surgical procedure
– Considerable extension of the indication in the area of beginning
osteoarthritis
This evaluation – in accordance with internationally recognised documentation
standards – six, nine, and in some cases twelve months after the operation,
includes 42 patients with a total of 51 different cartilage defects. The
predominating defects were defects on the femoral sides of the knee, the
posterior side of the patella, and on the opposite articular surface. Approx. 60
percent of the patients showed signs of the onset of osteoarthritis at the time
of treatment.
These early results show a lasting filling of the cartilage defect in all cases.
In addition, the patients have considerably less pain and a better quality of
life after the treatment. This positive trend could be confirmed to equal
degrees both in patients with defects due solely to accidents and in patients
with the onset of osteoarthritis. Should the further clinical results back up
these treatment successes, as a result of this biological therapy prosthetic
replacement of a knee-joint might be greatly postponed or entirely avoided. At
present approx. 50,000 knee-joint prostheses are in use in Germany alone.
The surgical technique permits – as a result of the combination of autologous
chondrocytes with the 3-dimensional matrix substance – simple, mechanically
stable fixation. As a result, the operating time in joint-opening procedures
could be shortened by up to 2/3 compared with the available methods used
hitherto. Moreover, 1/4 of the cases were treated arthroscopically (without
opening of the knee).
“BioSeed-C opens up completely new possibilities in the treatment of cartilage
defects in the knee-joint: as a result of a considerably shorter operating time,
wider areas of application, and arthroscopic implantation that will shortly be
standardised, more patients can be treated in a less stressful manner”, says Dr.
Christoph Erggelet, consultant at the Freiburg University Orthopaedic Clinic,
who developed the surgical technique.
On the basis of the results obtained up to now, BioTissue believes that the
indications for the use of BioSeed-C will increase considerably compared with
the previously known methods in the area of early osteoarthritis.
BioSeed-C is currently available throughout Germany. In 2003, in co-operation
with industrial partners, its availability is to increase to include other
European countries.
Additional information on cartilage damage:
Once the cartilage is damaged, in adults it can no longer regenerate. This leads
to even the slightest damage frequently developing into chronic defects, and
later into osteoarthritis. This can cause persistent pain and impaired mobility.
In the past there has been no satisfactory solution for the treatment of these
defects.
BioTissue has developed a novel tissue technology, through which it is possible
for the first time to produce 3-dimensional autologous cartilage tissue in the
laboratory. Particularly for tissues of the musculo-skeletal system that are
subject to great mechanical stress, such as bone and cartilage, it is crucial to
achieve 3-dimensional structures with a high degree of mechanical stability.
With the new procedure, a small sample of cartilage tissue is obtained, and the
chondrocytes are cultured in the patient’s own blood serum. Shortly before
transplantation, the cultured cells are combined with a matrix substance that
gives the cartilage replacement its 3-dimensional form. This patented, 3-
dimensional culture technique is the key to differentiating chondrocytes in
vitro (in the test tube) in such a way that they have already begun to form
cartilage substance at the time of the operation. As BioSeed-C is composed of
the patient’s own chondrocytes, a rejection reaction is impossible.
The technology from BioTissue Technologies was tested for ten years both in
vitro and in numerous experimental animal studies in vivo (in the body).
BioTissue launched the product BioSeed-C on the market in December 2001.
Contact:
BioTissue Technologies AG
Engesserstraße 4a / 4b
D-79108 Freiburg
Michaela Beaugrand
Investor- and Public Relations
Tel.+49 (0) 7 61 76 76-112
Fax +49 (0) 7 61 76 76-154
michaela.beaugrand@biotissue-tec.com
http://www.biotissue-tec.com
end of message, (c)DGAP 10.02.2003
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WKN: 618061; ISIN: DE0006180615; Index:
Listed: Neuer Markt in Frankfurt; Freiverkehr in Berlin, Düsseldorf, Hamburg,
Hannover, München und Stuttgart
100716 Feb 03
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