Use of Cultured Human Autologous Bone Marrow Stem Cells in Repair of a Rotator Cuff Tear: Preliminary Results of a Safety Study
Abstract
Rotator cuff tears are one of the most frequent shoulder disorders which are often associated with pain and interfere with proper arm function. In order to evaluate the safety and effectiveness of using cultured human autologous mesenchymal stem cells (MSC) applied to the suture site during arthroscopic repair of a rotator cuff tear, a prospective clinical study was designed and started recently at the authors' department.
Its primary goal was to evaluate the safety of using cultured human MSCs, the secondary goal then was to study a therapeutic effect of their application. Preliminary results of the study on a limited number of patients are presented here.
MATERIAL AND METHODS Ten patients who met the indication criteria for arthroscopic repair of a rotator cuff tear were included in the study. In addition, they also had to meet inclusion and lack exclusion criteria.
According to the protocol, their bone marrow was harvested at 3 to 4 weeks before surgery. Subsequently, an arthroscopic repair of the rotator cuff tear was performed and an suspension of cultured MSCs was applied to the suture site at the end of the procedure.
The isolation of MSCs from bone marrow and their cultivation was carried out by the company Bioinova, Ltd. The patients were followed up at 6 weeks and 3 and 6 months post-operatively.
Their clinical assessment included physical examination of the shoulder, pain intensity evaluation according to the visual analogue scale (VAS), and subjective questionnaires for Constant and University of California (UCLA) scores. All patients underwent MRI examination at 6 post-operative months to evaluate the quality of rotator cuff reconstruction.
The findings were compared with the pre-operative results.