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TiGenix公司研发的ChondroCelect 是干细胞疗法么??: ]2 ]3 a: V3 ^) ^
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ChondroCelect is a cell-based medicinal product for use in autologous chondrocyte implantation in which cells are taken from the patient’s own knee, multiplied to reach a large quantity, and then re-implanted at the site of the defect. ChondroCelect is indicated for the repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society grades III or IV) in adults.+ u. R+ ?: {/ F( D/ g
Treatment with ChondroCelect comprises a two-step surgical procedure. In the first step, a cartilage biopsy is obtained arthroscopically from healthy articular cartilage from a lesser-weight bearing area of the patient’s knee. Chondrocytes, the cells that produce and maintain the cartilage matrix, are isolated from the biopsy, expanded in vitro through a process based on cell characterisation, and delivered as a suspension for implantation in the same patient. ChondroCelect can be delivered nine weeks from the day of biopsy.% j+ M, ?* t5 ?% h
ChondroCelect was the first cell-based product approved in Europe that successfully completed the entire development track from research through clinical development to European approval and received European Marketing Authorization in October 2009 as the first Advanced Therapy Medicinal Product.ChondroCelect currently benefits from national reimbursement in the Netherlands and Spain. Effective 1 June 2014, the company has entered into a distribution agreement with Sobi (Swedish Orphan Biovitrum AB) for the exclusive marketing and distribution rights with respect to ChondroCelect in Europe (excluding Finland, where TiGenix has a pre-existing distribution agreement with Finnish Red Cross Blood Services), the Middle East and North Africa.
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, \3 g1 S, ^0 \6 x通篇只有讲是自体细胞活检后增殖? |
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