Condition: Intervertebral Disc Degeneration · Chronic Low-back Pain · Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
DREAM is a phase II B efficacy monocentric, prospective, randomized, controlled double blinded trial, comparing intra-discal autologous adult bone marrow mesenchymal stem cells (BM-MSC) therapy and sham treated controls in subjects with chronic (\> 6 months) Low Back Pain (LBP) due to lumbar multilevel (max. 3 levels) intervertebral disc degeneration (IDD) unresponsive to conventional therapy. Duration of the recruitment period has been estimated to be 12 months. The efficacy of intradiscal injection of autologous BM-MSC in reducing chronic LBP due to multilevel lumbar IDD will be evaluated after 24 months in terms of pain relief (VAS), functionality (ODI) and quality of life (SF36).
This description comes directly from the study's public registry record.
Gianluca Vadalà, MD, PhD · +39 06 22541918 · g.vadala@gmail.com
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| Campus Bio-Medico University of Rome | Roma, Italy, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05066334