JPRN-jRCTa050190104已完成未知
A clinical study for treatment of articular cartilage damage in knee joints with allogeneic induced pluripotent stem (iPS) cell-derived cartilage. - TACK-iPS
Matsuda Shuichi0 个研究点目标入组 4 人开始时间: 2020年2月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
Allogeneic iPS cell-derived cartilage is potentially at risk for tumorigenesis, but no neoplastic growths were observed at 12 months after iPS cartilage transplantation. Therefore, the safety of iPS cell-derived cartilage transplantation in humans was confirmed. Improvements in postoperative clinical, imaging, arthroscopic, and histologic evaluation scores were also observed, suggesting that iPS cell-derived cartilage transplantation might be a useful treatment for knee articular cartilage damage.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1) Patients with knee articular cartilage damage of grade III of Cartilage Repair Society (ICRS) articular cartilage injury classification diagnosed by arthroscopy or MRI.
- •2) Patients with knee articular cartilage damage with the size of 1-5 cm2 in total.
- •3) Patients who is aged between 20 and 70 when they consent.
- •4) Patients who have consent in the form of document.
- •5) Patients whose cartilage damage can be assessed by MRI at the time of screening.
排除标准
- •1) Patients who has or had malignant tumorswith cancer.
- •2) Patients who got damage or undergo the surgery as follows less than six weeks ago.
- •Ligament reconstruction in knee ligament (such as anterior cruciate ligament and posterior cruciate ligament) injury.
- •Meniscal suture or partial resection for meniscal injuries.
- •Around knee osteotomy in the lower limb alignment abnormality.
- •3) Patients who are scheduled for other surgeries of the lower limbs throughout this study, except prior surgery for comorbidities in this study or protocol treatment.
- •4) Patients who are impossible to undergo the postoperative rehabilitation due to abnormalities in the opposite lower limb
- •5) Patients with serious allergy to ingredients (e.g. bovine serum and/or rosuvastatin) which used for producing iPS cell-derived chondrocytes and fibrin glue in this study.
- •6) Patients with active infections.
- •7) Serious complications (e.g., heart disease, chronic respiratory disease, liver and kidney failure, uncontrolled diabetes, and hypertension) that may influence the conduct and evaluation of this study.
- •8) Patients who are pregnant, possibly pregnant, breast-feeding or wiling to be pregnant.
- •9) Patients with psychiatric disorders that may influence the conduct and evaluation of this study.
- •10) Patients whom the doctors considered inappropriate for the study.
研究者
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