Efficacy of Intradiscal Injection of Autologous BM-MSC in Subjects With Chronic LBP Due to Multilevel Lumbar IDD

NCT05066334 | Recruiting Phase 2 DMC

• 2 other identifiers: DREAM (GR - 2018-12367168)2019-002749-40
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Intervertebral Disc Degeneration; Chronic Low-back Pain

Keywords

Low Back Pain; Spine; Intervertebral Disc Degeneration; Mesenchymal Stem Cells; Bone Marrow

Outcome Measures

Primary Outcomes (2)

• Pain Change

  Changes in pain will be evaluated on Visual Analogic Scale (VAS) between baseline and month 24. VAS scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable.

  From Baseline to Month 24

• Functional disability index evaluation

  Functional disability changes will be assessed on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 24 compared with baseline. ODI scale ranges from 0 to 50 and allows evaluation of disability (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms).

  From Baseline to Month 24

Secondary Outcomes (15)

• Disability evolution

  Baseline, 3, 6, 12 and 24 months

• Quality of life evolution

  Baseline, 3, 6, 12 and 24 months

• Drug consumption of rescue painkillers medication

  Baseline, 3, 6, 12 and 24 months

• Measurement of pain

  Baseline, 3, 6, 12 and 24 months

• Employment and work status assessment

  Baseline and 24 months

Study Arms (2)

Active Arm

EXPERIMENTAL

Two procedures: 1. Bone marrow harvesting from the posterior superior iliac crest region 2. Single injections of a dose of 15 million of autologous BM-MSC for each disc affected by IDD (up to 3 discs) via imaging control

Drug: Autologous BM-MSC

Sham Procedure

SHAM COMPARATOR

Two sham procedures: 1. Simulated bone marrow harvesting without insertion into the posterior iliac crest region 2. Simulated injection under only local anaesthesia without disc injection and without placebo injection.

Procedure: Sham

Interventions

Autologous BM-MSC DRUG

intradiscal injection of autologous bone marrow mesenchymal stromal cells

Also known as: Treated

Active Arm

Sham PROCEDURE

local anaesthesia, no disc injection, no placebo injection

Also known as: Untreated

Sham Procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Symptomatic chronic LBP due to moderate IDD (modified Pfirrmann score 3-4, Griffith score 3-7) at max.3 levels of the lumbar spine unresponsive to conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments includes nonsteroidal anti-inflammatory drugs (NSAID), 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 24 months after BM-MSC discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.

You may not qualify if:

• Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenerative spondylolisthesis).
• 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 4th level with symptomatic IDD (modified Pfirrmann score 3-4, Griffith score 3-7) 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 II and 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 months.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Center for Outcomes Research and Clinical Epidemiology, Italy: collaborator

Study Sites (1)

Campus Bio-Medico University of Rome

Roma, Italy, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Interventions

Therapeutics; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Vadalà, MD, PhD

  Campus Bio-Medico University of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Vadalà, MD, PhD

CONTACT

+39 06 22541918; g.vadala@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The randomization will be centralized and stratified on the investigation center. Treatment allocation will be performed 24 hour-a-day online by a central randomization web-service. The patient identification must be unique within all randomizations performed. For double-blind trial the randomization result will be a treatment code. Blinding or masking will be carried out at all stages of packaging and conditioning for shipping following the treatment allocation. Injections used for all groups will be clear and indistinguishable from each other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in 2 arms of 26 patients and followed up for 24 months.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: October 4, 2021
• Study Start: March 22, 2021
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 25, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)