Therapeutic Efficacy of Autologous Non-Mobilized Enriched Circulating Endothelial Progenitors in Patients With Critical Limb Ischemia - The SCELTA Trial.
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Liotta Francesco, Annunziato Francesco, Castellani Sergio, Boddi Maria, Alterini Brunetto, Castellini Giovanni, Mazzanti Benedetta, Cosmi Lorenzo, Acquafresca Manlio, Bartalesi Filippo, Dilaghi Beatrice, Dorigo Walter, Graziani Gabriele, Bartolozzi Benedetta, Bellandi Guido, Carli Giulia, Bartoloni Alessandro, Fargion Aaron, Fassio Filippo, Fontanari Paolo, Landini Giancarlo, Lucente Eleonora A M, Michelagnoli Stefano, Orsi Battaglini Carolina, Panigada Grazia, Pigozzi Clara, Querci Valentina, Santarlasci Veronica, Parronchi Paola, Troisi Nicola, Baggiore Cristiana, Romagnani Paola, Mannucci Edoardo, Saccardi Riccardo, Pratesi Carlo, Gensini Gianfranco, Romagnani Sergio, Maggi Enrico
Аннотация
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 In both groups, the number of deaths and major amputations was lower compared with eligible untreated patients and historical reference patients.
CONCLUSIONS: This study supports previous trials showing the efficacy of BM-MNC autotransplantation in CLI patients and demonstrates comparable therapeutic efficacy between BM-MNC and EPEPCs.