CTRI/2018/02/011839招募中4 期
An open label, multicenter Post Marketing Surveillance Study in India to assess safety and efficacy of Intramuscular administration of stempeucel® in patients with critical limb ischemia due to Buergerâ??s disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any procedures.
- •2. Patients of either sex of 18 years and above with established clinical diagnosis of critical limb ischemia due to Buergerâ??s disease as per Rutherford classification (Rutherford III-5 or III-6 (gangrene limited to the toes)) (Refer Appendix I) with rest pain and / or ulcers in the affected limb.
- •3. Patients who are not eligible for or have failed traditional revascularization treatment
排除标准
- •Patients with known hypersensitivity to the excipients of the stempeucel® â?? dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
研究者
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