Therapeutic effects of human amnion-derived mesenchymal stem cells on hypercoagulability in a uremic calciphylaxis patient

Abstract

Calciphylaxis is a rare cutaneous vascular disease with clinical manifestations of intolerable pains, non-healing skin wounds, histologically characterized by calcification, fibrointimal hyperplasia, and thrombosis in microvessels. Currently, there are no approved guidelines for this disease. High prevalence of thrombophilias and hypercoagulable conditions in calciphylaxis patients have been recognized in recent years. Here, we report a case of uremic calciphylaxis patient whom was refractory to conventional treatments and then received a salvage strategy via human amnion-derived mesenchymal stem cell (hAMSC) intravenous combined with local application. In order to investigate the therapeutic mechanism of hMASCs from the novel perspective of hypercoagulability, coagulation-related indicators, wound status and quality of life were followed up. Improvement of hypercoagulable condition involving correction of platelet, D-dimer and plasminogen levels, skin regeneration and pain alleviation were revealed after hAMSC administration for one year. We propose that hypercoagulability is the therapeutic target of calciphylaxis patients which can be improved by hAMSC treatment.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT04592640

Funding Statement

This study was funded by the National Natural Science Foundation of China (81270408, 81570666, 81730041, and 81671447), the International Society of Nephrology (ISN) Clinical Research Program (18-01-0247), Construction Program of Jiangsu Provincial Clinical Research Center Support System (BL2014084), Jiangsu Province Key Medical Personnel Project (ZDRCA2016002), CKD Anemia Research Foundation from China International Medical Foundation (Z-2017-24-2037), Outstanding Young and Middle-Aged Talents Support Program of The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), the National Key Research and Development Program of China (2017YFC1001303), the Program of Jiangsu Province Clinical Medical Center (YXZXB2016001, BL2012009), the State Key Laboratory of Reproductive Medicine Program (SKLRM-GC201803), and the Program of Jiangsu Commission of Health (H201605).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics committee of Jiangsu Province Hospital (2012-SR-128, 2018-QT-001) gave ethical approval for this work. Healthy pregnant women in their 20s or 30s who provided written informed consent donated human amniotic membranes, which was approved by the Ethics Committee of Jiangsu Province Hospital (2012-SR-128).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

AbbreviationshAMSChuman amnion-derived mesenchymal stem cellCUAcalcific uremic arteriolopathyESKDend-stage kidney diseasePDperitoneal dialysisSHPTsecondary hyperparathyroidismVASVisual Analog ScaleBWATBates-Jensen Wound AssessmentWound-QoLWound-Quality of LifeCKRTcontinuous kidney replacement therapyCRPC reactive proteinTFtissue factorPRPplatelet-rich plasma.

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