A variety of biomaterials have been introduced as potential substrates for cartilage repair. One such candidate is chitosan, which shares some characteristics with glycosaminoglycan and hyaluronic acid present in articular cartilage. Depending on chitosan source and preparation procedure, variations into its properties can be attained. Thus, the aim of this article is to study and select the most adequate chitosan properties for in vivo osteochondral tissue regeneration. In this work, chitosan molecular weight, deacetylation degree, and calcium content are tested as material variable properties. According to these properties, porous scaffolds were prepared, implanted in rabbit knee osteochondral defects, and evaluated 3 months after surgery. Results show in vitro a considerable influence of the material molecular weight on the scaffold structure. In vivo, different tissue responses were observed depending on the implanted chitosan properties. Some samples showed no material degradation, multiple adverse tissue responses, and no bone/cartilage tissue formation. Other samples showed no adverse responses and bone and cartilage tissue regeneration. The chitosan with intact mineral content (17.9 wt %), lowest molecular weight (11.49 KDa), and lowest deacetylation degree (83%) shows a well structured subchondral bone and noticeable cartilaginous tissue regeneration, being it the best one of those tested for osteochondral defect regeneration.
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.
Electronic supplementary material
The online version of this article (10.1186/s13063-019-3504-3) contains supplementary material, which is available to authorized users.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.