JPRN-UMIN000017734已完成未知
A clinical trial for the validation of safety and efficacy of the implant-type tissue-engineered cartilage using autologous cells. - A clinical trial of the implant-type tissue-engineered cartilage using autologous cells.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Patients who meet any of the following criteria are excluded. 1. Patients from whom sufficient blood cannot be collected (e.g. by recent blood donation). 2. ASA physical status 3 or worse. 3. Existing or possible malignancy. 4. Uncontrolled diabetes. 5. Possible sepsis. 6. Recurrent skin infection at the surgical sites, e.g. ears or noses. 7. Patients who received, or will undergo surgeries at the operative sites within 1 year before surgery in this trial. 8. Females with existing or possible pregnancy, lactating, or who cannot agree with anticonception until 6 months after the transplantation of FSI2007. 9. Patients found positive in allergy test for atelocollagen 10. Possible syphilis, B/C hepatitis, HIV infection or adult T cell lymphoma. 11. Present, past or family histories of autoimmune diseases, e.g. rheumatoid arthritis, psoriatic arthritis, systemic/discoid lupus erythematosus, dermatomyositis, polymyositis, chronic thyroiditis, Graves' disease, polyartritis, scleroderma, ulcerous colitis, Crohn's disease, Sjogren's syndrome, Reiter syndrome, mixed connective tissue disease or relapsing polychondritis. 12. Histories of anaphylaxia. 13. Histories or possibilities of hypersensitivity or allergy to collagen products, lactic acid polymer, fibroblast growth factor (FGF), insulin, penicillin or streptomycin. 14. Patients who used or will use FGF-2, parathyroid hormone, insulin-like growth factor-I, insulin, growth hormone, female hormones (except cosmetics), male hormones, interleukin-1 receptor antagonist, thyroid hormone, vitamin D (except supplements) or steroids (except topical products) 3 months before blood collection. 15. Patients who were in other clinical trials or clinical researches within 30 days before the obtainment of the consent. 16. Patients with mental diseases who cannot fill out survey slips. 17. Patients judged to be inappropriate as subjects of this trial by the responsive doctor or assigned doctors.
研究者
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