Investigator-initiated clinical trial: Autologous peripheral blood-derived CD34+ cells transplantation for bone and vascular regeneration using with MB-001 and IK-02 in patients with Fracture non-union. - Investigator-initiated clinical trial: Autologous peripheral blood cell transplantation in patients with Fracture non-union.

Foundation for Biomedical Research and Innovation at Kobe0 个研究点目标入组 15 人开始时间: 2016年6月22日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 15

研究概览入排标准研究者记录与标识符相似试验

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)Congenital pseudarthrosis. 2)Multiple non-unions. 3)The patient receiving radiation therapy,chemotherapy,steroids or immunosuppressive agents. 4)Presence of limb paralysis due to neurological disorders such as cerebral infarction or spinal cord injury. 5)The patients with allergy to human serum albumin,hypersensitivity. 6)The patients with allergies to cow-derived protein,hypersensitivity. 7)History of anaphylaxis. 8)History of severe adverse drug reaction to G-CSF agent,collagen agent or apheresis. 9)History of hypersensitivity or drug reaction to mouse-derived proteins,iron or iron dextran. 10)The patient unable to discontinue anti-coagulant and anti-platelet agents during perioperative period. 11)Presenting with malignancy or history of malignancy within recent 5years. 12)Presenting with proliferative diabetic retinopathy. 13)History of unstable angina,myocardial infarction,cerebral infarction,cerebral hemorrhage or TIA within recent 3months. 14)Presenting with myeloproliferative disease or MDS. 15)Presenting with severe liver dysfunction,renal failure,heart disease,lung disease,hematologic disease,or endocrine and metabolic disorders. 16)The Patient with positive intradermal tests for atelocollagen. 17)Patient's or family presenting and/or history of autoimmune diseases such as RA,PsA,SLE,DM,PM,chronic thyroiditis,Graves'disease,polyarteritis scleroderma,ulcerative colitis,Crohn's disease,Sjogren syndrome,Reiter syndrome and MCTD. 18)Presence or history of interstitial pneumonia. 19)WBC count < 4,000/uL or WBC count > 10,000/uL 20)Plt count < 100,000/uL 21)Hb < 8g/dL 22)Presence of pathological splenomegaly identified by the US and CT. 23)The Patient received a surgery on nonunion within recent 6months. 24)The patient scheduled for surgery,except for non-union fracture,during the trial. 25)Positive serologic tests. 26)The patient with pregnancy or breast feeding. 27)The patient with alcohol and drug addiction.

研究者

发起方

Foundation for Biomedical Research and Innovation at Kobe

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