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

NCT04759105 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-25

No results posted yet for this study

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).

Conditions

  • Intervertebral Disc Degeneration
  • Chronic Low-back Pain

Interventions

DRUG

Autologous BM-MSC

intradiscal injection of autologous bone marrow mesenchymal stromal/stem cells

OTHER

Sham Procedure

anaesthesia, no disc injection, no placebo injection

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER

  • Center for Outcomes Research and Clinical Epidemiology, Italy

    collaborator OTHER

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Principal Investigators

  • Gianluca Vadalà, MD, PhD · Campus Bio-Medico University of Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-03
Primary Completion
2023-11-27
Completion
2023-11-27

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759105 on ClinicalTrials.gov