Kitala Diana, Łabuś Wojciech, Klama-Baryła Agnieszka, Kraut Małgorzata, Maj Mariusz, Szapski Michał
Dr Stanislaw Sakiel Centre for Burns Treatment, Siemianowice Śląskie, Poland.
Dr Stanislaw Sakiel Centre for Burns Treatment, Siemianowice Śląskie, Poland.
Transplant Proc. 2020 Oct;52(8):2563-2569. doi: 10.1016/j.transproceed.2020.01.110. Epub 2020 May 19.
Advances in science have allowed newly created medicinal products based on gene therapy, somatic cell therapy, and tissue engineering to be used in the treatment of human diseases. December 2008 legislation aims to ensure they are both safe for patients and available throughout the European Union. Amniotic stem cells are designated by the European Medicines Agency Committee for Advanced Therapies as an advanced therapy medicinal product; therefore, production must be in accordance with Regulation (EC) No. 1394/2007 of the European Council of 13 November 2007 on advanced therapy medicinal products.
This article details preliminary results of innovative amniotic stem cell transplant (supported by an acellular dermal matrix [ADM] produced in-house with Suprathel wound and burn dressing) in a burn patient and compares them with results in a patient treated with allogeneic skin.
Amniotic stem cells were applied to a 40-year-old patient with IIb°/III° thermal burns of 36% of total body surface area and III°/IV° of 1%. Wound healing was assessed by histologic examination and the Bates-Jensen scale. Reduction in pain perception was verified by 10-point visual analog scale. Hospitalization time was compared to length of stay for patients treated with standard therapy.
The patient was discharged from hospital on the 12th day after surgery with complete wound healing (almost 2 times shorter than the control).
The use of amniotic stem cells and ADM may be the optimal method for burn treatment.
科学的进步使得基于基因治疗、体细胞治疗和组织工程的新型医药产品得以用于治疗人类疾病。2008年12月的立法旨在确保这些产品对患者安全且在整个欧盟范围内均可获得。羊膜干细胞被欧洲药品管理局高级治疗委员会指定为高级治疗医药产品;因此,其生产必须符合欧洲理事会2007年11月13日关于高级治疗医药产品的第1394/2007号(EC)条例。
本文详细介绍了一名烧伤患者接受创新羊膜干细胞移植(由内部生产的脱细胞真皮基质[ADM]与Suprathel伤口和烧伤敷料支持)的初步结果,并将其与接受异体皮肤治疗的患者的结果进行比较。
将羊膜干细胞应用于一名40岁的患者,该患者全身表面积36%为IIb°/III°热烧伤,1%为III°/IV°烧伤。通过组织学检查和贝茨-詹森量表评估伤口愈合情况。通过10分视觉模拟量表验证疼痛感知的减轻情况。将住院时间与接受标准治疗的患者的住院时间进行比较。
患者术后第12天出院,伤口完全愈合(几乎比对照组短2倍)。
使用羊膜干细胞和ADM可能是烧伤治疗的最佳方法。