Mesenchymal stem cell therapy improved outcome of early post-traumatic shoulder osteonecrosis: a prospective randomized clinical study of fifty patients with over ten year follow-up.

PURPOSE: Post-traumatic osteonecrosis of the humeral head has a risk of progression to collapse in absence of treatment. The purpose of this study was to evaluate the results of mesenchymal stem cell grafting of the pre-collapse humeral head (study group) in adult patients with osteonecrosis and to compare the results with a simple core decompression without cells (control group). Patients After inclusion and randomization of 50 patients, 26 patients were enrolled in a single-blinded study for the cell therapy group. Twenty-four other patients were treated with simple core decompression without cells (control group).

MATERIAL AND METHODS: After a mean of 12-year (range 10 to 15) follow-up, X-ray and MRI were used to evaluate the radiological results, while the Constant score and the visual analog scale were chosen to assess the clinical results. The cell therapy group was treated with percutaneous mesenchymal cell (MSCs) injection obtained from bone marrow concentration. The average total number of MSCs (counted as the number of colony-forming units-fibroblast) injected in each humeral head was a total injection of average 180,000 ± 35,000 cells (range 74,000 to 460,000).

RESULTS: Both the treatment and control groups had a significantly improved clinical score (p < 0.01). At the last follow-up, pain on the visual analog scale and Constant score in the study group had significant improvement (respectively p < 0.001 and p < 0.01) as compared to the control group. Collapse was observed more frequently in the control group (87.5% versus 11.5% for cell therapy, p < 0.0001). The survival rates based on the requirement for further shoulder surgery (arthroplasty) as an endpoint were higher in the cell therapy group in comparison to those in the control group (92% versus 25%; p < 0.0001).

CONCLUSION: Core decompression with cell therapy was a safe and effective procedure for treatment in the pre-collapse stages of posttraumatic shoulder osteonecrosis and improved the outcome of the disease as compared with simple core decompression without cells.