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Efficacy of Intradiscal Injection of Autologous BM-MSC in Worker Patients Affected by Chronic LBP Due to Multilevel IDD

CompletedPhase 2NCT04759105
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
Autologous Mesenchymal Stem/Stromal Cells for the Treatment of Workers Affected by Chronic Low Back Pain Due to Multilevel InterVErtebral Disc Degeneration: a Phase IIB Randomized Clinical Trial
Conditions
Interventions
  • Drug: Autologous BM-MSC
  • Other: Sham Procedure
Sponsor
Fondazione Policlinico Universitario Campus Bio-Medico
Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Center for Outcomes Research and Clinical Epidemiology, Italy
Start date
2019-11-03
Primary completion
2023-11-27
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Italy
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Workers (it means subject has worked at least 2 months, even if not continuously, in the last 6 months) * Age between 18 and 65 years. * Signed informed consent. * Symptomatic chronic LBP due to moderate/severe IDD \[modified Pfirrmann score 3-5 (Pfirrmann et al., 2001), Griffith score 4-8 (Griffith et al., 2007)\] at max. 4 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes AINS, paracetamol, opioids and myorelaxant. * Annulus fibrosus intact, demonstrated by MRI. * Pain baseline \> 40 mm on VAS (0- 100). * NSAID washout of at least 2 days before screening. * Painkillers washout of at least 24 hours before screening. * For females of childbearing potential, a negative pregnancy test must be documented at Screening. * Men and women should use effective contraception during treatment and for at least 12 months after BM-MSC discontinuation. The complete list of contraceptive methods is described in the patient information sheet and in the paragraph 6.5. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC. Exclusion Criteria: * Non-workers (it means that the person has worked less than 2 months, although not continuously, in the last 6 months) * Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondilolisthesis). * Spinal segmental instability assessed by dynamic X-Ray. * Symptomatic facet joints syndrome on MRI (facet joints hyperintensity and hypertrophy evaluated at coronal T2 weighted MRI). * Prior to the screening visit, has received: * Oral corticosteroid therapy within the previous 3 months, OR * Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months * Presence of a 5th level with symptomatic IDD (modified Pfirrmann score 3-5, Griffith score 4-8) in the lumbar spine. * Spinal canal stenosis (Schizas score \> B). * History of spinal infection. * Lumbar disc herniation and sciatica. * Endplate abnormality such as Schmorl's Nodes. * Previous discal puncture or previous spine surgery. * IDD with Modic III changes on MRI images. * Patients not eligible to the intravertebral disc surgery. * Patients who have the risk to undergo a surgery in the next 6…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04759105