Development of a multidisciplinary and integrated approach for the management of the worker affected by degenerative pathologies of the spine: study of the employment aspects and of an innovative regenerative treatment of the intervertebral disc to favor the return to work
Project objectives
Low back pain is very often caused by a degenerative disease of the lumbar discs. Medical therapies available today are successful in temporarily relieving pain, however sometimes lower back pain becomes chronic. Today, no therapy can restore intervertebral disc function or provide long-term relief from degenerative lumbar disc disease. Autologous bone marrow mesenchymal stem cells are cells capable of self-renewal and differentiation. These cells are defined as autologous in nature as they are taken from the patient himself. Encouraging results suggest that regenerative stem cell-based therapies could avoid these problems, and provide the world's first effective therapy for this common and debilitating disease. Scientific studies have shown that these cells have anti-inflammatory properties, but only a high-quality randomized controlled study, which compares the injection of stem cells with the standard of care, can demonstrate whether this cell therapy is a truly effective alternative. to the treatment envisaged so far, which includes lumbar arthrodesis (surgical technique that allows the bones present in the lumbar spine to be joined together to stabilize it in order to reduce pain or deformity) and the implantation of disc prosthesis. In this clinical trial, a new treatment method will be applied, previously tested for the treatment of low back pain caused by early degenerative pathology of the lumbar discs. Mesenchymal stem cells are isolated from the patient's own bone marrow. A sufficient quantity of cells for injection into patients can be obtained by culturing them for several days. These cells will then be injected into the degenerated disc under fluoroscopic control or via CT scan in the operating room with local anesthesia. Autologous bone marrow mesenchymal cells will be classified as a medicinal product without marketing authorisation. However, the same cells have already been used in previous clinical studies. To date, it is not possible to answer the question regarding the benefit you will be able to derive from this new therapy. Results from a previous clinical trial indicate a rapid and progressive improvement in function indices of 65% to 78% over 1 year after intradiscal injection of allogeneic mesenchymal cells, with significant improvement in the disc cartilaginous matrix assessed by nuclear magnetic resonance imaging (RMN). Furthermore, the procedure appeared to be safe and no side effects were reported.
The general objective of the project is to develop an innovative integrated and multidisciplinary approach for workers suffering from degenerative pathologies of the spine and in particular from low back pain, based on treatments that favor preventive and personalized approaches, aimed at a rapid functional recovery and return to Work.
The technical and scientific objectives are:
- Development and experimentation of a multidisciplinary and integrated management model, from the diagnostic-therapeutic path to rehabilitation and job reintegration.
- Evaluation of the efficacy of intradiscal injection of mesenchymal stem/stromal cells for the prevention and treatment of low back pain caused by intervertebral disc degeneration
- Analysis of scenarios, needs and opportunities related to innovation and multidisciplinary approaches for prevention, treatment and reintegration into work in patients suffering from low back pain.
Project start and end date
10 June 2019 - 2022
Project managers
Prof. Vincezo Denaro - Scientific manager
Coordinating institution of the project
Campus Bio-Medico University Hospital Foundation
Other Institutions involved in the project
- INAIL
- University of Helsinki
- CF IRCCS Foundation Cà Granda Policlinico Hospital Milan
Funding source
INAIL-BRIC 2018
