Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial Description

Low back pain (LBP) is the global leading cause of disability, and furthermore rates sixth in terms of overall disease burden, in both developed and developing countries. LPB is a condition of all ages, from children to elderly, affecting 60-70 percent of the global population during life, and ~700 million people each year. LBP prevalence increases with age, and with populations ageing worldwide, the societal and economic burden associated with LBP will increase substantially over coming years. Current LBP therapies are aimed at pain reduction, and do not provide restorative treatment. Such conservative strategies (e.g. painkillers and musculoskeletal rearrangement by manual and physiotherapy) rarely address the actual cause of LBP. In a healthy spine, intervertebral discs (IVDs) separate the vertebrae to provide complex spinal flexibility while supporting large spinal loads. Intervertebral disc degeneration (IDD) is widely recognized as a major contributor to LBP, responsible for at least 40 percent of LBP cases. A key characteristic of IVD degeneration is loss of matrix integrity, thereby causing biomechanical functional failure. Today, no therapy can restore IVD function or provide long-term relief from symptomatic IDD. New treatment strategies concentrate on treating IDD at an early stage. Stem cell research offers exciting possibilities, and advanced cell-based therapies are considered highly promising strategies in treating IVD degeneration and LBP. Encouraging results suggest that cell-based, regenerative therapies may provide the world first effective therapy for this common and debilitating disease. The objective of DREAM is to generate efficacy and tolerability profiles of a single injection of 15 million of cells/ml of autologous BM-MSC for each disc affected by IDD (up to 3 discs) versus sham procedure. The potential of BM-MSC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by Magnetic Resonance Imaging (MRI) after 6 months, 1 and 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05066334
Study type Interventional
Source Campus Bio-Medico University
Contact Gianluca Vadalà, MD, PhD
Phone +39 06 22541918
Email [email protected]
Status Recruiting
Phase Phase 2
Start date March 22, 2021
Completion date June 9, 2023

See also
  Status Clinical Trial Phase
Completed NCT04046419 - In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"
Recruiting NCT05080101 - Effect of Basic Body Awareness Therapy on Pain, Sleep, Disability and Quality of Life N/A
Recruiting NCT04399772 - COgNitive FuncTional Therapy+ for Chronic Low Back paIn N/A
Recruiting NCT04555278 - Combining Non-invasive Brain Stimulation and Exercise to Treat Low Back Pain N/A
Not yet recruiting NCT04940715 - Efficacy of Passive Joint Mobilization vs Mobilization With Movement on Pain Processing in Patients With Chronic Low Back Pain N/A
Not yet recruiting NCT05050695 - Correlation Between Posterior Oblique Sling Activation and Contralateral Glenohumeral Stability in Low Back Pain
Recruiting NCT04683718 - A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prosperaâ„¢ SCS System With HomeStreamâ„¢ Remote Management N/A
Recruiting NCT05021146 - Essential Oil for Chronic Low Back Pain N/A
Recruiting NCT04610905 - The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population N/A
Not yet recruiting NCT04980612 - Mindfulness Based Pain Reduction N/A
Completed NCT04576520 - PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study N/A
Active, not recruiting NCT04141098 - Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy N/A
Not yet recruiting NCT05040633 - The ECEALT Chronic Low Back Pain Study N/A
Recruiting NCT04077632 - Effects of tDCS on Heart Rate Variability in Chronic Low Back Pain Phase 2/Phase 3
Completed NCT04090814 - TENS Reduces Movement-Evoked Pain in People With CLBP N/A
Completed NCT04099576 - The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain N/A
Recruiting NCT04099160 - Turkish Version of Revised Neurophysiology of Pain Questionnaire
Recruiting NCT04290221 - Effectiveness Analysis of Ultrasound-guided Intratissue Percutaneous Electrolysis (EPI) in Patient With Chronic Low Back Pain N/A
Completed NCT04378413 - Aquatic and Land Exercises in Chronic Low Back Pain N/A
Recruiting NCT04881188 - Risk and Protective Factors in Multimodal Pain Therapy in Patients With Chronic Lumbal Pain