MOLECULAR SYNOVECTOMY BY IN VIVO GENE TRANSFER

通过体内基因转移进行分子滑膜切除术

• 批准号: 6113526
• 负责人: BLAKE J ROESSLER
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6113526
• 关键词: articular cartilage; clinical research; clinical trial phase I; dosage; ganciclovir; gene therapy; human subject; human therapy evaluation; immunopathology therapy; orthopedics; plasmids; recombinant DNA; rheumatoid arthritis; transfection

We propose a phase-I dose-escalation study of intra-articular pNGVL-TK plasmic DNA followed by systemic ganciclovir (hereafter referred to as TK/GCV) for treatment of active rheumatoid synovitis of the knee. We propose to study 4 doses of pNGVL-TK plasmid DNA over a range of one and one-half logs (0.3 mg, 1.0 mg, 3.3. mg, 10.0 mg). A constant dose of intravenous ganciclovir (5 mg/kg twice daily for 3 days) will be used for each dose of pNGVL-TK plasmid DNA tested. We propose to study 2 patients at each dose of pNGVL-TK plasmic DNA, a total of 8 patients.

我们提出了一项i期剂量增加研究，关节内pngv1 -TK血浆DNA，然后全身更昔洛韦（以下简称TK/GCV）治疗活动性膝关节类风湿性滑膜炎。我们建议在1.5 log （0.3 mg, 1.0 mg, 3.3 mg）范围内研究4种剂量的pngv1 - tk质粒DNA。毫克，10.0毫克)。每一剂量pngv1 - tk质粒DNA检测将使用恒剂量静脉注射更昔洛韦（5mg /kg，每日两次，连续3天）。我们拟研究pNGVL-TK血浆DNA每剂量2例患者，共8例。