CTRI/2025/06/088469尚未招募Unknown
An observational, practice based, open label, multicenter, post marketing surveillance study in India to assess safety and efficacy of intramuscular administration of REGENACIP® in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease.
Stempeutics Research Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年6月24日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Safety Endpoint:
研究概览
简要总结
This is an observational, open label, multicenter, post marketing surveillance study in India to assess safety and efficacy of intramuscular administration of REGENACIP® in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Written, signed, dated informed consent obtained from patients.
- •Patients of either sex of 18 years and above with established clinical diagnosis of critical limb ischemia due to Buerger’s disease as per Rutherford classification [Rutherford III-5 or III-6 (gangrene limited to the toes)] (Refer Appendix III) with rest pain and / or ulcers in the affected limb.
- •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 REGENACIP® – dimethylsulfoxide (DMSO) or human serum albumin (HSA).
结局指标
主要结局
Safety Endpoint:
时间窗: 1, 6 and 12 months
- Evaluation of adverse events
时间窗: 1, 6 and 12 months
- Evaluation of drug related adverse events
时间窗: 1, 6 and 12 months
- Evaluation of occurence of clinical abnormality at site of injection, calf area, vital signs and physical examinations
时间窗: 1, 6 and 12 months
次要结局
- Efficacy assessment will include:(- Rest pain score (VAS Scale score of 0 to 10) (refer appendix II) & or)
研究者
Dr Pawan Kumar Gupta
Stempeutics Research Pvt Ltd
研究点 (1)
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