JPRN-UMIN000002993已完成1 期
A Phase I/ II Clinical Trial: Autologous CD34+ Cell Transplantation for Bone and Vascular Healing in Patients with Non-Union Fracture - Cellular Therapy for Patients with Non-Union Fracture
Ryosuke Kuroda, M.D., Ph.D.0 个研究点目标入组 17 人开始时间: 2010年1月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
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 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients (Pts) with congenital femoral or tibial fracture 2) Pts with multiple pseudoarthrosis 3) Pts with radiation therapy, chemotherapy, steroid therapy or immunosuppressant 4) Pts with limb paralysis due to cerebral infarction or spinal cord injury 5) Pts with a history of severe allergic reactions or side effects to G-CSF, collagen products or apheresis 6) Pts with malignant tumor or with a history of malignant tumor in last 5 years 7) Pts with diabetic proliferating retinopathy 8) Pts with unstable angina 9) Less than 6 months since last episode of myocardial/cerebral infarction 10) Pts with leukemia, myeloproliferative disease, or myelodysplastic syndromes 11) Pts with allergic reaction to atelocollagen 12) Pts or their family currently suffering from or having a history of autoimmune disease 13) Pts with end stage renal disease on maintenance hemodialysis 14) Pts with cirrhosis of the liver 15) Pts currently suffering from or having a history of interstitial pneumonitis 16) Pts with cerebral aneurysm indicative for surgical/endovascular treatment by neurosurgeon 17) Leukocytes less than 4,000/uL or exceeding 10,000/uL 18) Platelets less than 100,000/uL 19) Hemoglobin less than 8g/uL 20) AST exceeding 100 IU/uL or ALT exceeding 100 IU/uL 21) Pts with splenomegaly 22) Pts with severe ulcer/ gangrene in the legs with pseudoarthrosis 23) Pts with an operative treatment for the pseudoarthrosis performed in the last 9 months 24) Pts having a plan of another operative treatment in the period of current clinical research 25) Pts infected with HBV, HCV, HIV or HTLV 26) Pts with infectious diseases accompanied by fever over 38 C 27) Pts with uncontrollable mental diseases 28) Pts participating in other clinical trials 29) Pregnant or nursing patients, those who may be pregnant or plan on becoming pregnant before the end of the study period 30) Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study
研究者
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