ChondroCelect (R) from Tigenix is an autologous chondrocyte treatment for articular cartilage defects of the knee. The product is a cell-based medicinal product for the repair of cartilage defects of the knee. Micheline Wille was an employee of TiGenix NV at the time of this analysis and provided the clinical data on ChondroCelect and had an advisory input into the study . TiGenix NV (EURONEXT BRUSSELS: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. Continue Learn More. +32 16 39 60 97 About TiGenix TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. After obtaining positive animal data, TiGenix decided to test it applicability to humans and so took the tough road of five years clinical trials comparing micro-fracture surgery with ChondroCelect. Since then, MACI entered the US . ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI) . Takeda and TiGenix entered into an exclusive ex-US license, development, and commercialization agreement in July 2016 for Cx601, the leading investigational therapy in TiGenix's pipeline. It is locally administered to treat complex perianal fistulas in . News; Analysis; Policy & Pricing; Insights; Events; Medtech ChondroCelect | European Medicines Agency ChondroCelect Share RSS characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins Table of contents Overview Authorisation details Product information Assessment history Withdrawn This medicine is now withdrawn from use in the European Union. General ChondroCelect is an autologous product and should under no circumstances be administered to other patients. You may also be interested in. TiGenix acquired ChondroMimetic with its purchase of Orthomimetics last year (www.clinica.co.uk, 16 November 2009). Tigenix is a public biomedical company that focuses on Regenerating Motion. Subject: US FDA asks for additional study of TiGenix's ChondroCelect Add a personalized message to your email. Louvain-la-Neuve, August 27, 2009 - IDDI (International Drug Development Institute), a corporation based in Belgium, reports that its collaboration with TiGenix resulted in the approval by European Medicines Agency for the Evaluation of Medicinal Products (EMEA) of ChondroCelect for the treatment of full thickness cartilage defects in the knee. ChondroCelect, indicated for cartilage repair in the knee, is a cell-based medicinal product for use in autologous chondrocyte implantation in which cells are taken from the . TiGenix is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect. ChondroCelect (CC) is a cell-based therapy approved for use in autologous chondrocytes implantation (ACI) to treat symptomatic cartilage defects of the femoral condyle. Of course, this process has been patented and led to the creation of TiGenix. The company's lead product, ChondroCelect, for cartilage repair in the knee, is the only approved cell-based product in Europe, and is currently being launched in different . TiGenix now has two products approved for marketing and sales in Europe: ChondroCelect, the company's lead product for cartilage regeneration in the knee, is the first cell- based product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. Send. Patients with femoral epiphyseal growth plate that is not fully closed . TiGenix announced that it has acquired Orthomimetics, a privately held medical technology company based in the United Kingdom. Tigenix kreeg al in oktober 2009 goedkeuring om ChondroCelect op de Europese markt te commercialiseren maar dat liep niet echt van een leiden dakje. Cancel. Health Biotechnology Areas of activity Biodrugs Stem cells Cellular Therapy Therapeutic areas Dermatology . TiGenix n.v. ClinicalTrials.gov Identifier: NCT00414700 Other Study ID Numbers: TIG/ACT/01/2000&Extension BB IND 12491 0007 ( Other Identifier: CBER ) TiGenix is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect. IDDI Reports Successful Partnership with TiGenix for Approval of ChondroCelect IDDI's contributed statistical methodology towards approval of ChondroCelect TiGenix's lead product for the treatment of full thickness cartilage defects in the knee. ChondroCelect produces higher-quality cartilage with five-year clinical superiority. The therapy will be made available to 130,000 patients in Europe . All other readers will be directed to the abstract and would need to subscribe. TiGenix says the product fills a niche not currently covered by its own pipeline, which is headed by ChondroCelect. TiGenix CEO Eduardo Bravo said the EMA has approved the Netherlands facility for the. Eduardo Bravo, CEO of European cell therapy company TiGenix, with a distinguished track record behind him in big pharma, walked away with the prize for the development of ChondroCelect, the first cell therapy to get EU approval under new regulations that went into force in 2009. Clinical results demonstrated that ChondroCelect formed regenerated cartilage that was superior to the repair tissue obtained by microfracture, the current standard of care for cartilage defects in the knee. Dit is een nieuwe, veelbelovende vorm van therapie. TiGenix NV, which notified the European Com mission of its decision to permanently discontinue the marketing of the product for commercial reasons. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). In 2012, TiGenix's state-of-the-art manufacturing facility in Sittard Geleen, the Netherlands, successfully passed cGMP inspection by the Dutch authorities, and obtained approval from the European Medicines Agency for the production of ChondroCelect, the company's commercial cell therapy product for cartilage repair in the knee. About ChondroCelect. . TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage. Pharma Consulting & Analytics; Data Feeds and APIs; Evaluate Vantage. TiGenix's stem cell therapy, Cx601, is entering Phase III to treat perianal fistulas. TiGenix and PharmaCell have signed an agreement to purchase the shares of TiGenix B.V., which holds the manufacturing site, subject to certain closing conditions and intend to close the transaction in the coming months. ChondroCelect was the first cell-based product to be approved in Europe. MACI was first approved in Europe after Vericel Corporation acquired the cell therapy and regulatory media business of Genzyme, but the plant was closed in September 2014 because of low sales . 2,500 implantations a year from the current 85 should take TiGenix to profit. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and osteoarthritic joints. . TiGenix also has a commercialized product (ChondroCelect) for cartilage repair in the knee, which was the first ever approved commercial cell-based product in Europe in 2009 (Advanced Therapy. ChondroCelect must not be used in case of advanced osteoarthritis of the knee. Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on 'Regenerating Motion'. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced . The synergies between Chondromimetic and ChondroCelect . Adis is an information provider. The Dutch National Health Authority (NZa) has formally announced that ChondroCelect is to receive national reimbursement retroactively per January 1, 2012. Withdrawal of the marketing authorisation in the European Union . 4.4 Special warnings and precautions for use . From June 2014, the marketing and distribution rights of ChondroCelect have been exclusively licensed to Sobi for the . Belgian biotech company TiGenix is planning to list on Euronext Brussels after it received positive feedback on clinical trials of its treatment for cartilate defects, it said in a statement on . From June 2014, the marketing and distribution rights of ChondroCelect have been exclusively licensed to Sobi for the . The company is exploiting the power of Regenerative Medicine to develop durable treatments for damaged and diseased skeletal tissues. . It has brought to the market the very first cell therapy product officially approved in Europe in 2009, ChondroCelect, an autologous chondrocyte implantation therapy for cartilage repair in the. De kraakbeenceltherapie ChondroCelect van het Leuvense bedrijf Tigenix, wordt vanaf nu terugbetaald door de ziekteverzekering. Tigenix Contact Description Contact information Tigenix, SAU Pilar Redondo, Site Head margarita.garcia@takeda.com Marconi, 1. TiGenix and PharmaCell have signed an agreement to purchase the shares of TiGenix B.V., which holds the manufacturing site, subject to certain closing conditions and intend to close the transaction in the coming months. TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. The drug candidate is a suspension of allogeneic-expanded adipose-derived stem cells. Leuven (BELGIUM) - June 8, 2012 - TiGenix (NYSE Euronext: TIG) announced today that its innovative cartilage repair therapy ChondroCelect has obtained national reimbursement in the Netherlands. TiGenix - Belgium. TiGenix has received a positive opinion from the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the European Marketing Authorisation application (MAA) for its lead product ChondroCelect P&G to co-promote Somaxon's Silenor in the US The move comes some six weeks after TiGenix won European Medicines Agency approval Oct. 9 for commercial production of ChondroCelect at its European manufacturing plant in Sittard-Geleen, the. This autologous cell-based product is indicated to repair cartilage in otherwise healthy knees. Tissue regeneration specialist TiGenix of Leuven, Belgium said it is to go public on the Euronext market in Brussels to finance the registration, production and marketing of its cartilage replacement product ChondroCelect, and to expand and accelerate the development of its pipeline of cell-based products.. PiperJaffray and ING have been appointed as lead managers and . 6 February 2012 . As part of that shift, TiGenix said, it was withdrawing its European marketing authorization application for ChondroCelect , an autologous cell therapy product for cartilage repair of the knee.. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). ChondroCelect is commercially available in Belgium, the Netherlands, Luxembourg, Germany, the United Kingdom, Finland and Spain. 12""3. Designed to guarantee formation . 11,2,1,1,1,3,8,8,ChondroCelect ,ChondroCelect, ChondroCelect TiGenix 200910 TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic, or. About TiGenix. including with respect to the anticipated future performance of TiGenix and the market in which it operates. Jan de Backer - CEO, Fluidda. Please Note: Only individuals with an active subscription will be able to access the full article. From June 2014, the marketing and distribution rights of ChondroCelect were exclusively licensed to Sobi for the European . TiGenix is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect. . Louvain-la-Neuve, August 27, 2009 - IDDI (International Drug Development Institute), a ChondroCelect2009 ChondroCelectTiGenix Of course, this process has been patented and led to the creation of TiGenix. Sobi will continue to market and distribute the product in Belgium, the Netherlands and Spain, where it is currently available. TiGenix is a research client of Edison Investment Research Limited . From June 2014, the marketing and distribution rights of ChondroCelect have been exclusively licensed to Sobi for the . Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the company has acquired the licencing rights to market and distribute ChondroCelect, a cell-based medicinal product for the repair of cartilage defects of the knee, from TiGenix NV (Euronext Brussels: TIG). Overview TiGenix and PharmaCell have signed an agreement to purchase the shares of TiGenix B.V., which holds the manufacturing site, subject to certain closing conditions and intend to close the transaction in the coming months. . Investment opportunity. IDDI's contributed statistical methodology towards approval of ChondroCelect TiGenix's lead product for the treatment of cartilage repair in the knee. 23 Mar 2010 News Katie McQue katie.mcque@informa.com Executive Summary The US FDA has requested an additional clinical trial of TiGenix's cartilage re-generation product ChondroCelect before it can be approved, the company has said. ChondroCelect, is the first cell-based product that successfully completed the entire development track from research, over . In Belgi wordt een behandeling al sinds een jaar terugbetaald door de sociale zekerheid en vandaag kwam er ook witte rook uit Nederland. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that the company has acquired the licencing rights to market and distribute ChondroCelect, a cell-based medicinal product for the repair of cartilage defects of the knee, from TiGenix NV (Euronext Brussels: TIG). Its corporate headquarters are in Leuven, Belgium, and it has operations in Madrid, Spain. For profit Phase 2 Phase 3. Defects are debrided, and the defect is sealed with a biological membrane. Have you used this device? . Louvain-la-Neuve, August 27, 2009 - IDDI (International Drug Development Institute), a corporation based in Belgium, reports that its collaboration with TiGenix resulted in the approval . ChondroCelect First ever ATMP1 approved by EMA . After obtaining positive animal data, TiGenix decided to test it applicability to humans and so took the tough road of five years clinical trials comparing micro-fracture surgery with ChondroCelect. TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). . Alternative Names: ChondroCelect; ChondroCelect-3D; TGX 001; TGX 002; TGX002/FAB002 Latest Information Update: 02 Oct 2021. ChondroCelect . About TiGenix TiGenix NV (NYSE Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. 2009Tigenix2018ChondroCelect5 TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. +32 16 39 79 73 About TiGenix TiGenix NV (Euronext Brussels: TIG) is a leading European cell therapy company with a marketed product for cartilage repair, ChondroCelect, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix has selected TFS International (TFS) for the first clinical trial (SEPCELL) to use stem cell therapy in the treatment of severe sepsis secondary to severe community acquired pneumonia (sCAP). TiGenix showcased the CE marked product at the annual meeting of the International Cartilage Repair Society, held in Barcelona, Spain on 26-29 September. ChondroCelect. About TiGenix. . TiGenix is a European cell therapy company with a proprietary validated allogeneic expanded adipose-derived stem cell (eASC) platform technology for the treatment of autoimmune and inflammatory diseases, and a commercialized product. ChondroCelect, before it could submit it for US FDA approval (www . ChondroCelect is a regenerative autologous medicinal product indicated for the repair of full thickness cartilage lesions of the knee. ChondroCelect received pan-European marketing clearance in October. TiGenix is exploiting the power of regenerative medicine to develop durable treatments, validated through controlled clinical trials, for these indications. Price : $50 * Buy Profile. This acquisition further supports TiGenix' growth strategy of becoming a leading player in the promising and fast-growing field of regenerative medicine. This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Parque Tecnolgico de Madrid Tres Cantos Madrid 918049264 918049263 https://www.takeda.com/ Areas of activities A. . Fluidda is the world leader in the field of functional respiratory imaging which combines HRCT scans and computational fluid dynamics technology. Chondromimetic forms an excellent fit with TiGenix's lead product ChondroCelect, since both products target the same customer base. ChondroCelect was the first cell-based product to be approved in Europe. information RGLEMENTE8 NOVEMBRE 2012 TiGenix : actualits oprationnelles &donnes financires cls pour le T3 de 2012 Ventes de ChondroCelect : 3,20 millions d'euros pour les neuf . TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the . Among these products, the license for ChondroCelect was withdrawn by TiGenix N.V. in 2016 for commercial reasons . Founded: Leuven Belgium (2000) Status: Acquired by Takeda (2018) CEO Jan de Backer outlines the major developments of Commenting on the strategic fit between the companies, Andrew Lynn, chief executive officer of Orthomimetics, who will now assume business-development responsibilities at TiGenix as chief business officer, said . TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company's expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based. TiGenix NV (NYSE Euronext: TIG) is a leading European cell therapy company with a commercial product and an advanced clinical stage pipeline of adult stem cell programs. ChondroCelect. Related Interviews. 2009Tigenix2018ChondroCelect5 ChondroCelect First cell-based medicinal product authorised under the ATMP framework Safeguarding tissues and cells for human application October 21 st , 2010 Gil Beyen, CEO. On 29 July 2016, the European Commission withdrew the marketing authorisation for ChondroCelect .