학술논문
Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia ― The SCELTA Trial ―
Document Type
Journal Article
Author
Aaron Fargion; Alessandro Bartoloni; Beatrice Dilaghi; Benedetta Bartolozzi; Benedetta Mazzanti; Brunetto Alterini; Carlo Pratesi; Carolina Orsi Battaglini; Clara Pigozzi; Cristiana Baggiore; Edoardo Mannucci; Eleonora A.M. Lucente; Enrico Maggi; Filippo Bartalesi; Filippo Fassio; Francesco Annunziato; Francesco Liotta; Gabriele Graziani; Giancarlo Landini; Gianfranco Gensini; Giovanni Castellini; Giulia Carli; Grazia Panigada; Guido Bellandi; Lorenzo Cosmi; Manlio Acquafresca; Maria Boddi; Nicola Troisi; Paola Parronchi; Paola Romagnani; Paolo Fontanari; Riccardo Saccardi; Sergio Castellani; Sergio Romagnani; Stefano Michelagnoli; Valentina Querci; Veronica Santarlasci; Walter Dorigo
Source
Circulation Journal. 2018, 82(6):1688
Subject
Language
English
ISSN
1346-9843
1347-4820
1347-4820
Abstract
Methods and Results:ECEPCs (obtained from non-mobilized peripheral blood by immunomagnetic selection of CD14+and CD34+cells) or BM-MNC were injected into the gastrocnemius of the affected limb in 23 and 17 patients, respectively. After a mean of 25.2±18.6-month follow-up, both groups showed significant and progressive improvement in muscle perfusion (primary endpoint), rest pain, consumption of analgesics, pain-free walking distance, wound healing, quality of life, ankle-brachial index, toe-brachial index, and transcutaneous PO2. In ECEPC-treated patients, there was a positive correlation between injected CD14+CD34lowcell counts and the increase in muscle perfusion. The safety profile was comparable between the ECEPC and BM-MNC treatment arms. In both groups, the number of deaths and major amputations was lower compared with eligible untreated patients and historical reference patients.