Project objectives
Low back pain is considered one of the major causes of disability globally: its prevalence increases with age and its main cause is intervertebral disc degeneration. This process is characterized by a progressive alteration of the structure of the disc extracellular matrix due to catabolic phenomena accompanied by the early depletion of the stem compartment of the resident cells which, therefore, are no longer able to maintain the integrity of the matrix.
Current therapeutic strategies are mainly aimed at controlling lumbar pain through physiotherapy and the administration of analgesics, while in the case of chronic intractable low back pain, the last remedy remains surgery, burdened by non-negligible failure rates and long rehabilitation periods.
For these reasons, research is engaging in the identification of therapeutic tools that can slow down or ideally stop the degenerative process at an early stage. In this sense, the use of mesenchymal stem cells taken from the bone marrow has proved to be effective and safe in numerous preclinical trials and limited clinical studies.
The main objective of the project is to evaluate the efficacy of intradiscal injection of autologous bone marrow-derived mesenchymal stem cells in the reduction of chronic low back pain due to disc degeneration localized at only one level. Pain will be assessed by the visual analog scale (VAS) and functional status by the Oswestry disability index (ODI) both calculated 12 months after treatment. Responders will be defined as those who report an improvement in the scales of at least 40%.
The secondary objective of the project is the evaluation of regenerative modifications of the levels treated by magnetic resonance using T2, T1 spin/echo and T1rho sequences.
The tertiary objective of the project is to evaluate the long-term safety and tolerability of the treatment, measured by recording adverse events up to 2 years after treatment.
Start and end date
2019 - 2022
Project managers
Dr. Gianluca Vadalà - Coordinator
Prof. Rocco Papalia
Prof. Vincenzo Denaro
Coordinating institution of the project
Università Campus Bio-Medico di Roma
Other institutions involved in the project
IRCCS Ca' Granda Foundation General Hospital Milan
Funding source
Call for Finalized Research 2018 - Young Researchers - Ministry of Health
