ChondroCelect 36 month data published in the American Journal of Sports Medicine
October 29, 2009 - TiGenix (NYSE EURONEXT BRUSSELS: TIG) announced that the 36 month follow-up data of the ChondroCelect® TIG/ACT/01/2000 clinical study were published in the American Journal of Sports Medicine.
The publication entitled 'Treatment of Symptomatic Cartilage Defects of the Knee: Characterized Chondrocyte Implantation Results in Better Clinical Outcome at 36 Months in a Randomized Trial Compared to Microfracture.' by D. Saris, J. Vanlauwe et al. is now available as e-publication ahead of print in the American Journal of Sports Medicine, the official journal of the American Orthopaedic Society for Sports Medicine (AOSSM). It is one of the highest ranked, peer-reviewed orthopaedic and sport sciences journals.
The manuscript describes the clinical outcome after 36 months of the multi-centre prospective randomized controlled trial assessing the efficacy of ChondroCelect for the treatment of symptomatic cartilage defects of the knee, as compared to the current standard of care, microfracture.
The authors conclude: 'Characterized chondrocyte implantation for the treatment of articular defects of the femoral condyles of the knee results in better clinical outcome at 36 months in
a randomized trial compared with microfracture. Time to treatment and quality of the cells were shown to affect clinical outcome.'
The abstract of the publication can be found on-line:
http://ajs.sagepub.com/content/early/2009/10/20/0363546509350694.abstract
Gil Beyen, CEO of TiGenix comments: 'The publication of these three-year data in a highlevel, peer-reviewed orthopaedic journal provides an important scientific confirmation of the
clinical benefit of ChondroCelect treatment over microfracture. These findings, in combination with the previously published results demonstrating structural superiority of ChondroCelect over microfracture, will certainly contribute to the positioning of ChondroCelect as the standard of care for cartilage defects.'
For more information, please contact
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
----------------------------------------
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic
joints.
TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an
increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical need. Current therapies do not provide satisfying, longterm durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect
ChondroCelect®, the company's lead product for cartilage regeneration in the knee, is the first cellbased
product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of
characterised cultured chondrocytes derived from the patient's own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited.
On October 5, 2009 ChondroCelect received European marketing authorisation as the first Advanced Therapy Medicinal Product, indicated for repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
The publication entitled 'Treatment of Symptomatic Cartilage Defects of the Knee: Characterized Chondrocyte Implantation Results in Better Clinical Outcome at 36 Months in a Randomized Trial Compared to Microfracture.' by D. Saris, J. Vanlauwe et al. is now available as e-publication ahead of print in the American Journal of Sports Medicine, the official journal of the American Orthopaedic Society for Sports Medicine (AOSSM). It is one of the highest ranked, peer-reviewed orthopaedic and sport sciences journals.
The manuscript describes the clinical outcome after 36 months of the multi-centre prospective randomized controlled trial assessing the efficacy of ChondroCelect for the treatment of symptomatic cartilage defects of the knee, as compared to the current standard of care, microfracture.
The authors conclude: 'Characterized chondrocyte implantation for the treatment of articular defects of the femoral condyles of the knee results in better clinical outcome at 36 months in
a randomized trial compared with microfracture. Time to treatment and quality of the cells were shown to affect clinical outcome.'
The abstract of the publication can be found on-line:
http://ajs.sagepub.com/content/early/2009/10/20/0363546509350694.abstract
Gil Beyen, CEO of TiGenix comments: 'The publication of these three-year data in a highlevel, peer-reviewed orthopaedic journal provides an important scientific confirmation of the
clinical benefit of ChondroCelect treatment over microfracture. These findings, in combination with the previously published results demonstrating structural superiority of ChondroCelect over microfracture, will certainly contribute to the positioning of ChondroCelect as the standard of care for cartilage defects.'
For more information, please contact
Gil Beyen
Chief Executive Officer
Kris Motmans
Corporate Communications
T: +32 16 39 60 60
----------------------------------------
About TiGenix
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic
joints.
TiGenix is developing a portfolio of products that address specific musculoskeletal problems. The lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an
increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical need. Current therapies do not provide satisfying, longterm durable repair and TiGenix therefore believes there is a need for more effective treatments for
cartilage damage.
About ChondroCelect
ChondroCelect®, the company's lead product for cartilage regeneration in the knee, is the first cellbased
product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of
characterised cultured chondrocytes derived from the patient's own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited.
On October 5, 2009 ChondroCelect received European marketing authorisation as the first Advanced Therapy Medicinal Product, indicated for repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
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