RT Journal Article
T1 Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full thickness rotator cuff tears
A1 Lamas, José Ramón
A1 García Fernández, Carlos
A1 Tornero Esteban, Pilar
A1 Lópiz Morales, María Yaiza
A1 Rodríguez Rodríguez, Luis
A1 Ortega Medina, Luis
A1 Fernández Gutiérrez, Benjamín
A1 Marco Martínez, Fernando
AB Purpose: The purpose of the study was to compare the safety and efficacy of autologous mesenchymal stem cells (MSCs) embedded in a xenogenic scaffold for repairing the supraspinatus tendon. Methods: This was a randomized, double-blind and placebo-controlled trial evaluating patients with full-thickness rotator cuff tears (Eudra-CT, 2007-007630-19). Effectiveness was evaluated using the Constant score and a visual analogue pain scale (VAS). Constant score has four domains including pain (15 possible points), activities of daily living (20 possible points), mobility (40 possible points), and strength (25 possible points). Scores range from 0 points (most disability) to 100 points (least disability). The structural integrity of the repaired tendon was assessed by magnetic resonance imaging (MRI) according to Patte and Thomazeau classification criteria. The primary study end point was an improvement in the Constant score by 20 points at one year compared to initial assessment. Results: The trial was stopped due to adverse effects observed in both groups. Only thirteen patients were included and analyzed. The Constant questionnaire showed a significant improvement in the MSC treatment group compared with the preoperative data (p = 0.0073). Secondary outcome measures were similar in both groups. Conclusions: Our study showed preliminary inconclusive clinical outcomes in the patients treated with MSCs. Adverse events revealed the need for further approaches using scaffolds of a different nature or perhaps no scaffolds, in the context of small joints. Trial registration: Eudra-CT, 2007-007630-19. Registered on 30 January 2008. Level of evidence: A Level 1 of evidence treatment study.
PB BMC. Springuer
SN 1745-6215
YR 2019
FD 2019-07-01
LK https://hdl.handle.net/20.500.14352/107392
UL https://hdl.handle.net/20.500.14352/107392
LA eng
NO Lamas JR, García-Fernández C, Tornero-Esteban P, Lópiz Y, Rodriguez-Rodriguez L, Ortega L, Fernández-Gutiérrez B, Marco F. Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears. Trials. 2019 Jul 1;20(1):387. doi: 10.1186/s13063-019-3504-3. PMID: 31262366; PMCID: PMC6604436.
NO Ministerio de Economia y Competitividad (España)
NO Instituto de Salud Carlos III (España)
DS Docta Complutense
RD 20 ago 2024