人类胎盘衍生细胞 (PDA-002) 在糖尿病足患者中,有或没有外周动脉疾病:第二期多中心,随机,双盲,安慰剂控制的试验
Richard Pollak1, James Anderson2, Bert Altmanshofer3
1Endeavor Clinical Trials PA, San Antonio, Texas, USA.
International wound journal
|October 12, 2025
概括
人类胎盘衍生细胞 (PDA-002) 显示出治疗糖尿病足的前景,特别是在患有外周动脉疾病的患者中. 在临床试验中,最低剂量显示出显著的伤口愈合和耐用性.
科学领域:
- 再生医学是一种再生医学.
- 细胞疗法细胞疗法
- 血管生物学 血管生物学
背景情况:
- 患有外周动脉疾病 (PAD) 的患者的糖尿病足 (DFU) 是一个重大的临床挑战.
- 目前用于DFU的治疗方法,特别是在PAD的背景下,有效性有限.
- 人类胎盘衍生细胞 (PDA-002) 具有血管新生和再生性质,表明其具有治疗潜力.
研究的目的:
- 评估PDA-002在治疗慢性糖尿病足的安全性和有效性.
- 评估PDA-002对患有外周动脉疾病和没有外周动脉疾病的患者伤口关闭率和耐久性的影响.
- 为了确定PDA-002的最佳剂量用于DFU管理.
主要方法:
- 进行了一项多中心,随机,双盲,安慰剂控制的2期试验.
- 159名患有慢性DFU的成年参与者根据PAD状态进行了分层.
- 参与者接受了肌肉内PDA-002剂量为3×10^6,10×10^6,或30×10^6细胞,或安慰剂.
主要成果:
- PDA-002的耐受性很好,没有与治疗相关的严重不良事件.
- PDA-002的3×10^6细胞/m2剂量在PAD亚组中显示出最高的疗效,其中38.5%实现了完整的伤口关闭,而安慰剂为22.6%.
- 治疗达到4周的耐用性终点,超过了FDA的建议.
结论:
- PDA-002显示出作为糖尿病足的新型治疗药物的潜力,特别是在患有并存的外周动脉疾病的患者中.
- 最低的PDA-002测试剂量是有效的,耐受性很好,表明一个有前途的治疗策略.
- 需要对PDA-002用于DFU管理进行进一步的调查.
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