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Open Access 01-12-2019 | Painful Arc | Research

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Authors: José Ramón Lamas, Carlos García-Fernández, Pilar Tornero-Esteban, Yaiza Lópiz, Luis Rodriguez-Rodriguez, Luis Ortega, Benjamín Fernández-Gutiérrez, Fernando Marco

Published in: Trials | Issue 1/2019

Abstract

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.

Available only for authorised users

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Title: Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears
Authors: José Ramón Lamas
Carlos García-Fernández
Pilar Tornero-Esteban
Yaiza Lópiz
Luis Rodriguez-Rodriguez
Luis Ortega
Benjamín Fernández-Gutiérrez
Fernando Marco
Publication date: 01-12-2019
Publisher: BioMed Central
Keyword: Painful Arc
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3504-3

At a glance: The STEP trials

Springer Medicine

Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears

Abstract

Purpose

Methods

Results

Conclusions

Trial registration

Level of evidence

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Trial registration

Level of evidence

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