Several clinical trials have proved the efficacy and safety of T-cells chimeric antigen receptor (CAR-T cells) in treatment of malignant lymphoma and the first products were registered in the European Union in 2018. The shelf-life of CAR-T cell products in the liquid state is short, so cryopreservation offers a significant benefit for logistics in manufacturing and patient management. Direct shipment of the cryopreserved CAR-T cell therapy products to the clinical department is feasible, nevertheless, intermediate storage in the hospital cryostorage facility gives significant advantage in planning of their administration to patients. Moreover, some manufacturers prefer transport of the starting material cryopreserved at the collection site. The cryopreservation protocol used for starting material by the authors is based on combining dimethyl sulphoxide (DMSO) with hydroxyethyl starch (HES) and slow controlled cooling in cryobags housed in metal cassettes. This achieves the mononuclear cell post-thaw viability of 98.8 ± 0.5 % and recovery of 72.8, ± 10.2 %. Transport of the starting material to the manufactures and return transport of the CAR-T therapy product is performed by authorized courier companies. Intermediate cryostorage of the final CAR-T cell therapy product is performed in a separate dry-storage liquid nitrogen container. On the day of infusion, the cryopreserved products are transported to the clinical department in a dry shipper. On the wards the product is removed from the cassette, inserted into a sterile plastic bag, thawed in a 37 degree C water bath followed by immediate intravenous administration. The authors discuss the adherence of the used technology to good manufacturing practice (GMP) principles and genetic safety assurance rules. Doi: 10.54680/fr23310110112.
- MeSH
- chimerické antigenní receptory * genetika MeSH
- imunoterapie adoptivní metody MeSH
- kryoprezervace metody MeSH
- lidé MeSH
- nízká teplota MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Předkládáme kazuistické sdělení léčby infekčního abdominálního aneuryzmatu pomocí miniinvazivní endovaskulární metody za využití stent graftu. U stejné pacientky byl pro jatemí cirhózu a opakované krvácení z jícnových varixů proveden TIPS (transjugulámí portosystémový zkrat) pro dekompresi portální hypertenze. V diskusi je rozebrána standardní léčba infekčního aneryzmatu a jsou zvažovány výhody a možnosti miniinvazní endovaskulární léčby pomocí stent-graftu. Pro přesné posouzení dalšího vývoje zavedeného stent-graftu do místa infekce bude nutné pravidelné sledování pacientky a dlouhodobá antibiotická léčba. Endovaskulární léčba stent-graftem a antibiotická terapie infekčního aneuryzmatu břišní aorty může být alternativou standardní chirurgické léčby.
The authors present a case of an infected abdominal aortic aneurysms by means of a minimally invasive endovascular method using a stent graft. This patient had already been treated by TIPS (transjugular intrahePatic portosystemic shunt) for repeated varicose bleeding due to liver cirrhosis. Standard surgical therapy of infected abdominal aneurysms and about advantages and possibilities of endovascular treatment with stent grafts are discussed. Regular follow-up of the patient and long-term antibiotics therapy are important for accurate assessment of an implanted stent graft into the infected abdominal aorta. Endovascular stent graft combined with antibiotic therapy may be an alternative to conventional open surgery in managing infected infrarenal abdominal aneurysms.
- MeSH
- aneurysma břišní aorty farmakoterapie mikrobiologie terapie MeSH
- aortitida mikrobiologie MeSH
- bakteriální infekce a mykózy farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- stenty MeSH
- výkony cévní chirurgie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
