CLINICAL MANAGEMENT PROTOCOL FOR CALCIPHYLAXIS TREATED WITH HUMAN AMNIOTIC-DERIVED MESENCHYMAL STEM CELLS

 

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CLINICAL MANAGEMENT PROTOCOL FOR CALCIPHYLAXIS TREATED WITH HUMAN AMNIOTIC-DERIVED MESENCHYMAL STEM CELLS

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Ningning
Wang
Ningning Wang wangnn@njmu.edu.cn the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Division of Nephrology, Department of Geriatrics Nanjing China *
Ming Zeng zengm1@sina.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Department of Nephrology Nanjing China -
Jingjing Wu 13913911556@163.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Department of Nephrology Nanjing China -
Baiqiao Zhao zbq19851010@163.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Division of Nephrology, Department of Geriatrics Nanjing China -
Jiaying Hu hujiaying0727@163.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Department of Nephrology Nanjing China -
Qinyi Lin 1030921469@qq.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Division of Nephrology, Department of Geriatrics Nanjing China -
Jingfeng Zhu zjf8712@njmu.edu.cn the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Department of Nephrology Nanjing China -
Zhonglan Su suzhonglan@jsph.org.cn the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Department of Dermatology Nanjing China -
Wuziyi Ji jwzy2233@126.com Nanjing University of Chinese Medicine Nanjing University of Chinese Medicine Nanjing China -
Jiahui Yang yjh791019@163.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Division of Nephrology, Department of Geriatrics Nanjing China -
Ling Wang 1846250395@qq.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital Division of Nephrology, Department of Geriatrics Nanjing China -
Lianju Qin ljqin@njmu.edu.cn the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital State Key Laboratory of Reproductive Medicine and Offspring Health, Center of Clinical Reproductive Medicine Nanjing China -
Jiayin Liu jyliu_nj@126.com the First Affiliated Hospital with Nanjing Medical University, Jiangsu Province Hospital State Key Laboratory of Reproductive Medicine and Offspring Health, Center of Clinical Reproductive Medicine Nanjing China -
 
 

Calciphylaxis, also known as calcific uremic arteriolopathy (CUA), is a rare cutaneous microvascular disorder predominantly affecting patients with chronic kidney disease (CKD). It clinically manifests as rapidly progressive ischemic skin necrosis and ulceration, frequently complicated by severe secondary infections and even septic shock. Skin biopsy remains the gold standard for diagnosis, and the condition carries a one-year mortality rate as high as 80%. The lack of standardized clinical protocols limits the efficacy of conventional multidisciplinary approaches. Advances in regenerative medicine have recently offered new hope for this refractory disease. Human amniotic-derived mesenchymal stem cells (hAMSCs) have attracted considerable interest owing to their wide availability, lack of ethical issues, strong proliferative potential, and significant immunomodulatory and paracrine activities.

Since September 2018, with approval from the hospital ethics committee, our team has innovatively administered hAMSCs to treat over ten patients with calciphylaxis who showed poor response to conventional therapies. Procedural skin biopsy please see Fig 1. Here we systematically summarizes the clinical management protocol, including patient selection, multidisciplinary consultation, baseline assessment and wound care. Wound status is evaluated using the Bates-Jensen Wound Assessment Tool for Calcific Uremic ArteriolopathyBWAT-CUA) scoring system, and pain intensity is measured using the Visual Analogue Scale (VAS).


For wound management, key assessment dimensions and grading criteria should  guide the selection of appropriate dressings and treatment protocols (Fig 2).

Fig 2. Key Considerations for Wound Care in Patients with Calciphylaxis



The hAMSC product is manufactured by the hospital’s stem cell technology platform and has passed quality re-evaluation by the National Institutes for Food and Drug Control. The administration regimen is individualized and combined: intravenous infusion at a dose of 1.0×10⁶cells/kg and local intralesional injection at 2.0×10⁴cells/cm² of wound surface (Fig 3). 

Figure 3. Flowchart of stem cell therapy


Acute adverse events are closely monitored throughout treatment, with established emergency response protocols. Preliminary long-term follow-up data suggest that hAMSC therapy is both safe and effective.

Based on these encouraging results, larger-scale, multicenter studies are warranted to validate the long-term efficacy and safety of hAMSC therapy. Future research should incorporate dynamic biomarker monitoring, optimize treatment protocols, strengthen multidisciplinary collaboration, and promote the standardized and precision-driven translation of stem cell therapies, ultimately establishing safer, more effective, and cost-efficient regenerative medicine approaches for patients.

Kewords