Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee - Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee

Ryosuke Kuroda, M.D., Ph.D0 个研究点目标入组 10 人开始时间: 2012年6月15日最近更新: 2023年10月17日

试验速览

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•1. patient with knee osteoarthritis (articluar cartilage changed denatuation) 2. patient with more than one site of arthropathia in lower extremity 3. patient with more than two sites of articular cartilage lesions, or focal cartilage lesions on both sides of kneejoints that need for treatment 4. patient with gout or pseudogout 5. patient with articular cartilage lesions in both articular surface and other side surface 6. patient with paralysis associated with neurological disease 7. patient need for bone transplantation from other site, for example, ilium (excluding removal of free bone fragment and irrigation of lesion site) 8. patient with a history of surgery or its need, for example of ablation or suturation of knee meniscus in injured side, but except in the presence of passed consistent term (8 wks over) after surgery of ablation or suturation of maximum partial knee meniscus of 1/3 9. patient with a history of surgery or its need, for example of ligament reconstruction of knee in diseased side, but except in the presence of passed consistent term (8 wks over) after surgery of ablation or suturation of knee meniscus 10. patient with a history of allergic reaction to collagen-containing products 11. patient with a history of serious hypersensitivity or anaphylactic shock to fibrin glue (Bolheal)

发起方

Ryosuke Kuroda, M.D., Ph.D