PDF(Pubmed)
Abstract：
BACKGROUND: Mesenchymal stromal/stem cells (MSCs) play a critical role in wound healing. Corlicyte® is an MSC product derived from allogeneic umbilical cord tissue donated under an institutional review board-approved protocol and processed in accordance with section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. This open-label phase 1 trial was performed under a United States Food and Drug Administration Investigational New Drug Application to establish the safety and tolerability of Corlicyte® in patients with diabetes and chronic diabetic foot ulcer (DFU).
METHODS: Escalating doses were applied topically twice a week for up to 8 weeks after ulcer debridement, wound photography, and measurement. Subjects were followed for 4 weeks after the treatment phase. Adverse events were assessed at every visit.
RESULTS: Nine subjects in 2 dosing cohorts completed the trial. No subjects experienced a serious adverse reaction to Corlicyte® or the development of anti-human leukocyte antigen (HLA) antibodies. Sixty percentage of subjects in the lower dose cohort experienced ulcer closure by Day 70 of follow-up, while the mean ulcer size was reduced by 54-67% in the other subjects.
CONCLUSIONS: Topical administration of Corlicyte®, a novel biologic therapy consisting of allogeneic umbilical cord lining MSCs, appeared safe and tolerable and resulted in a significant decrease in ulcer area, demonstrating its potential as a therapy for healing of chronic DFU.
METHODS: Escalating doses were applied topically twice a week for up to 8 weeks after ulcer debridement, wound photography, and measurement. Subjects were followed for 4 weeks after the treatment phase. Adverse events were assessed at every visit.
RESULTS: Nine subjects in 2 dosing cohorts completed the trial. No subjects experienced a serious adverse reaction to Corlicyte® or the development of anti-human leukocyte antigen (HLA) antibodies. Sixty percentage of subjects in the lower dose cohort experienced ulcer closure by Day 70 of follow-up, while the mean ulcer size was reduced by 54-67% in the other subjects.
CONCLUSIONS: Topical administration of Corlicyte®, a novel biologic therapy consisting of allogeneic umbilical cord lining MSCs, appeared safe and tolerable and resulted in a significant decrease in ulcer area, demonstrating its potential as a therapy for healing of chronic DFU.
摘要：
背景：间充质基质/干细胞（MSC）在伤口愈合中起关键作用。Corlicyte®是一种MSC产品，源自根据机构审查委员会批准的方案捐赠的同种异体脐带组织，并根据联邦食品第501（a）（2）（B）条进行处理，药物，化妆品法案。这项开放标签的1期试验是根据美国食品和药物管理局研究新药申请进行的，目的是确定Corlicyte®在糖尿病和慢性糖尿病足溃疡（DFU）患者中的安全性和耐受性。
方法：溃疡清创术后，每周局部应用两次递增剂量，持续8周，伤口摄影,和测量。在治疗期后随访受试者4周。在每次访问时评估不良事件。
结果：2个给药队列中的9名受试者完成了试验。没有受试者经历对Corlicyte®或抗人白细胞抗原(HLA)抗体的发展的严重不良反应。在随访的第70天，低剂量队列中有60％的受试者经历了溃疡闭合，而其他受试者的平均溃疡大小减少了54-67%。
结论：局部给药Corlicyte®，一种由同种异体脐带间充质干细胞组成的新型生物疗法，显得安全和可耐受，并导致溃疡面积显着减少，证明其作为治疗慢性DFU的潜力。
方法：溃疡清创术后，每周局部应用两次递增剂量，持续8周，伤口摄影,和测量。在治疗期后随访受试者4周。在每次访问时评估不良事件。
结果：2个给药队列中的9名受试者完成了试验。没有受试者经历对Corlicyte®或抗人白细胞抗原(HLA)抗体的发展的严重不良反应。在随访的第70天，低剂量队列中有60％的受试者经历了溃疡闭合，而其他受试者的平均溃疡大小减少了54-67%。
结论：局部给药Corlicyte®，一种由同种异体脐带间充质干细胞组成的新型生物疗法，显得安全和可耐受，并导致溃疡面积显着减少，证明其作为治疗慢性DFU的潜力。
