Diabetes Complications Research, Steno Diabetes Center Copenhagen, Borgmester Ib Juuls Vej 83, 2730, Herlev, Denmark.
Orthopedic Department, Nordsjællands Hospital Hilleroed, Dyrehave Vej 2, 3400, Hilleroed, Denmark.
Stem Cell Res Ther. 2022 Jun 28;13(1):280. doi: 10.1186/s13287-022-02951-8.
The aim of this study was to investigate safety of treating diabetic foot ulcers with a topically administered mesenchymal stem cell product.
Individuals with diabetes, peripheral neuropathy, toe blood pressure > 39 mmHg and non-infected foot ulcers with duration of four to fifty-two weeks were screened. Participants were treated with a one-time application of a topically applied allogeneic cellular product containing CD362 enriched mesenchymal stem cells suspended in a collagen solution. Participants were subsequently followed for seven months to gather information on adverse event and serious adverse events.
RESULTS/DISCUSSION: A total of sixteen individuals were screened, of whom two were included. The included participants incurred a total of seven adverse events and one serious adverse event. Increased exudation from the treated diabetic foot ulcer was observed for both participants and a connection to investigational medicinal product was suspected. The increased exudation was resolved within one week after application of investigational medicinal product, without any further complications. The serious adverse event consisted of a hospital admission due to neurological symptoms, which were assumed to be caused by hypoglycemia, with no suspected correlation to the investigational medicinal product. None of the other observed adverse events were suspected to be associated with the investigational medicinal product.
This study presents data from two individuals with a diabetic foot ulcer treated with a novel topical mesenchymal stem cell product. An adverse event observed for both participants was suspected to be associated to the investigational medicinal product, i.e., increased exudation, which was resolved within one week, did not lead to further complications and can easily be remedied by choosing bandages with higher absorption capacity or increasing frequency of bandage changes. This study lays the groundwork for further large scale randomized clinical studies.
EudraCT number 2015-005580-16. Registered 12/06-2018.
本研究旨在探讨局部应用间充质干细胞产品治疗糖尿病足溃疡的安全性。
筛选出糖尿病、周围神经病变、足趾血压 > 39 mmHg 和非感染性溃疡病程为 4 至 52 周的个体。参与者接受一次局部应用同种异体细胞产品的治疗，该产品含有富含 CD362 的间充质干细胞，悬浮在胶原溶液中。随后对参与者进行为期七个月的随访，以收集不良事件和严重不良事件的信息。
结果/讨论：共筛选出 16 名个体，其中 2 名被纳入。纳入的参与者共发生 7 起不良事件和 1 起严重不良事件。两名参与者的治疗性糖尿病足溃疡均出现渗出增加，怀疑与研究药物有关。在应用研究药物后一周内，渗出增加得到解决，没有进一步的并发症。严重不良事件包括因神经症状住院，推测由低血糖引起，与研究药物无明显相关性。其他观察到的不良事件均未怀疑与研究药物有关。
本研究报告了两名糖尿病足溃疡患者使用新型局部间充质干细胞产品治疗的结果。两名参与者均观察到的不良事件疑似与研究药物有关，即渗出增加，在一周内得到解决，未导致进一步并发症，且可通过选择吸收能力更高的绷带或增加绷带更换频率轻易解决。本研究为进一步的大规模随机临床试验奠定了基础。
EudraCT 编号 2015-005580-16。注册于 2018 年 12 月 6 日。
