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: 6274760
• 负责人: BLAKE J ROESSLER
• 金额: $ 2.15万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274760
• 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 on-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.

我们建议进行关节内pNGVL-TK的i期剂量递增研究