Efficacy of Intradiscal Injection of Autologous BM-MSC in Worker Patients Affected by Chronic LBP Due to Multilevel IDD
Status:
Recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
ACTIVE is a phase II B efficacy monocenter, prospective, randomized, controlled double
blinded trial, in which intra-discal autologous adult BM-MSC therapy will be compared with
sham treated controls.
This trial will evaluate the efficacy of intradiscal injection of autologous BM-MSCs in
workers affected by chronic low back pain (LBP) unresponsive to conventional therapy.
The efficacy will be evaluated 12 months after the treatment in terms of pain relief (VAS,
Visual Analog Scale), functionality (ODI, Oswestry Disability Index), quality of life (SF36,
Short Form - 36) and work ability index (WAI).
Phase:
Phase 2
Details
Lead Sponsor:
Campus Bio-Medico University
Collaborators:
Center for Outcomes Research and Clinical Epidemiology, Italy Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico