Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.
Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.
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DOI：
10.1371/journal.pone.0195891
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发表时间：
2018
期刊：
影响因子：
3.7
通讯作者：
Research Group Study EudraCT 2008-004015-35
中科院分区：
文献类型：
--
作者：
Fernández O;Izquierdo G;Fernández V;Leyva L;Reyes V;Guerrero M;León A;Arnaiz C;Navarro G;Páramo MD;Cuesta A;Soria B;Hmadcha A;Pozo D;Fernandez-Montesinos R;Leal M;Ochotorena I;Gálvez P;Geniz MA;Barón FJ;Mata R;Medina C;Caparrós-Escudero C;Cardesa A;Cuende N;Research Group Study EudraCT 2008-004015-35
Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded. Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy. Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.
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影响因子：
48
作者：
Connick, Peter;Kolappan, Madhan;Crawley, Charles;Webber, Daniel J.;Patani, Rickie;Michell, Andrew W.;Du, Ming-Qing;Luan, Shi-Lu;Altmann, Daniel R.;Thompson, Alan J.;Compston, Alastair;Scott, Michael A.;Miller, David H.;Chandran, Siddharthan
通讯作者：
Chandran, Siddharthan
影响因子：
--
作者：
Karussis, Dimitrios;Karageorgiou, Clementine;Vaknin-Dembinsky, Adi;Gowda-Kurkalli, Basan;Gomori, John M.;Kassis, Ibrahim;Bulte, Jeff W. M.;Petrou, Panayiota;Ben-Hur, Tamir;Abramsky, Oded;Slavin, Shimon
通讯作者：
Slavin, Shimon
影响因子：
9.3
作者：
Politis M;Lindvall O
通讯作者：
Lindvall O
影响因子：
168.9
作者：
Panes, Julian;Garcia-Olmo, Damian;Danese, Silvio
通讯作者：
Danese, Silvio
影响因子：
3.7
作者：
Llufriu S;Sepúlveda M;Blanco Y;Marín P;Moreno B;Berenguer J;Gabilondo I;Martínez-Heras E;Sola-Valls N;Arnaiz JA;Andreu EJ;Fernández B;Bullich S;Sánchez-Dalmau B;Graus F;Villoslada P;Saiz A
通讯作者：
Saiz A