Pre-clinical Research of Human Amnion-derived Mesenchymal Stem Cells and its First Clinical Treatment for a Severe Uremic Calciphylaxis Patient
By
Lianju Qin,
Jing Zhang,
Yujie Xiao,
Kang Liu,
Yugui Cui,
Fangyan Xu,
Wenkai Ren,
Yanggang Yuan,
Chunyan Jiang,
Song Ning,
Ming Zeng,
Guang Yang,
HanYang Qian,
Anning Bian,
Fan Li,
xiaoxue Ye,
Shaowen Tang,
Juncheng Dai,
Jing Guo,
Qiang Wang,
Bin Sun,
Yifei Ge,
Chun Ouyang,
Xueqiang Xu,
Jing Wang,
Yaoyu Huang,
Hongqing Cui,
Jing Zhou,
Meilian Wang,
Zhonglan Su,
Yan Lu,
Di Wu,
Zhihong Zhang,
Jingping Shi,
Wei Liu,
Li Dong,
Yinbing Pan,
Baiqiao Zhao,
Ying Cui,
Xueyan Gao,
Zhanhui Gao,
Xiang Ma,
Aiqin Chen,
Jie Wang,
Meng Cao,
Qian Cui,
Li Chen,
Feng Chen,
Youjia Yu,
qiang Ji,
Zhiwei Zhang,
Mufeng Gu,
Xiaojun Zhuang,
Xiaolin Lv,
Hui Wang,
Yanyan Pan,
Ling Wang,
Xianrong Xu,
Jing Zhao,
Xiuqin Wang,
Cuiping Liu,
Ningxia Liang,
Changying Xing,
Jiayin Liu,
Ningning Wang
Posted 24 Sep 2021
medRxiv DOI: 10.1101/2021.09.23.21261751
Calciphylaxis is a rare disease characterized histologically by microvessel calcification and microthrombosis, with high mortality and no proven therapy. We reported a severe uremic calciphylaxis patient with progressive skin ischemia, large areas of painful malodorous ulcers and mummified legs. Because of her rapid progression and refractory to conventional therapy, human amnion-derived mesenchymal stem cells (hAMSCs) treatment was approved. Establishment and release inspection of hAMSCs, efficacy and safety assessment including cytokines secretory ability, immunocompetence, tumorigenicity and genetics analysis in vitro were introduced. We further performed acute and long-term hAMSC toxity evaluations in C57BL/6 mice/rats, abnormal immune response tests in C57BL/6 mice and tumorigenic tests in the neonatal NU nude mice. After pre-clinical research, she was treated by hAMSCs with intravenous and local intramuscular injection and external supernatants application to her ulcers. When followed up to 15 months, her blood-based markers of bone and mineral metabolism were improved, with regeneration of skin soft tissue and a more favorable profile of peripheral blood mononuclear cells. Skin biopsy after 1 month treatment showed vascular regeneration with mature non-calcified vessels within dermis and 20 months later re-epithelialization restored the integrity of damaged site. No infusion or local treatment related adverse events occurred. To the best of our knowledge, this is the first evidence for the clinical use of hAMSCs. These findings suggest hAMSCs warrant further investigation as a potential regenerative treatment for uremic calciphylaxis with effects of inhibiting vascular calcification, stimulating angiogenesis and myogenesis, anti-inflammatory and immune modulation, multi-differentiation, re-epithelialization and restorage of integrity.
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