drugset / Trial / NCT04759105
Efficacy of Intradiscal Injection of Autologous BM-MSC in Worker Patients Affected by Chronic LBP Due to Multilevel IDD
Phase 2
Completed
48 enrolled
Fondazione Policlinico Universitario Campus Bio-Medico
Center for Outcomes Research and Clinical Epidemiology, Italy · collabFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · collab
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2019-11-03
- Primary completion
- 2023-11-27
- Completion
- 2023-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous BM MSC | Cell therapy | 1.5e+07 cells | Other |