Evidence map›Paper›PMID 40462867›Full record

ArticleJOR spine2025

Intradiscal Mesenchymal Stromal Cell Therapy for the Treatment of Low Back Pain Due to Moderate-to-Advanced Multilevel Disc Degeneration: A Preliminary Report of a Double-Blind, Phase IIB Randomized Clinical Trial (DREAM Study).

Gianluca Vadalà, Fabrizio Russo, Cristiana Lavazza, Giorgia Petrucci, Luca Ambrosio, Silvia Budelli, Elisa Montelatici, Giuseppina Di Giacomo, Claudia Cicione, Veronica Tilotta and 10 more

Abstract read
In one paragraph

Article in JOR spine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Gianluca VadalàOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.ORCID https://orcid.org/0000-0001-7142-1660
Fabrizio RussoOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Cristiana LavazzaUnit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan Italy.
Giorgia PetrucciOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Luca AmbrosioOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.ORCID https://orcid.org/0000-0003-2424-1274
Silvia BudelliUnit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan Italy.
Elisa MontelaticiUnit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan Italy.
Giuseppina Di GiacomoLaboratory for Regenerative Orthopaedics, Research Unit of Orthopaedic and Trauma Surgery Department of Medicine and Surgery, Università Campus Bio-Medico di Roma Rome Italy.
Claudia CicioneLaboratory for Regenerative Orthopaedics, Research Unit of Orthopaedic and Trauma Surgery Department of Medicine and Surgery, Università Campus Bio-Medico di Roma Rome Italy.
Veronica TilottaLaboratory for Regenerative Orthopaedics, Research Unit of Orthopaedic and Trauma Surgery Department of Medicine and Surgery, Università Campus Bio-Medico di Roma Rome Italy.
Giuseppe Francesco PapaliaOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Matteo PileriOperative Research Unit of Radiology and Interventional Radiology Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Amalia BrunoOperative Research Unit of Radiology and Interventional Radiology Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Salvatore La RosaUnit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan Italy.
Emilio CarrinoUnit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan Italy.
Eliodoro FaiellaOperative Research Unit of Radiology and Interventional Radiology Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Massimiliano CarassitiOperative Research Unit of Anesthesia and Intensive Care Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Lorenza LazzariUnit of Cell and Gene Therapies Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano Milan Italy.
Rocco PapaliaOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.
Vincenzo DenaroOperative Research Unit of Orthopaedic and Trauma Surgery Fondazione Policlinico Universitario Campus Bio-Medico Rome Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Low back pain (LBP) is a leading cause of disability worldwide, often associated with intervertebral disc degeneration (IDD). Mesenchymal stromal cells (MSCs) have emerged as a promising regenerative therapy for IDD due to their ability to promote tissue repair. This phase IIB randomized controlled trial aimed to evaluate the safety and efficacy of autologous bone marrow-derived MSC (BM-MSC) intradiscal injections in patients with chronic LBP due to moderate-to-advanced multilevel IDD. Methods: Fifty-two patients with chronic LBP unresponsive to conservative treatments with moderate-to-advanced IDD at up to three lumbar levels were included. Participants were randomized to receive either BM-MSCs or a sham procedure. Clinical outcomes, including pain intensity (VAS), disability (ODI), and quality of life (SF-36), were assessed at baseline, 1-, 3-, and 6-months postinjection. Structural changes were evaluated via MRI using Pfirrmann grading, disc height index (DHI), and T2 mapping at baseline, 3 and 6 months. Results: Of the 52 enrolled patients, 46 completed the 6-month follow-up (BM-MSC group: Conclusions: Autologous BM-MSC intradiscal injection is a safe and promising approach in patients with chronic LBP due to moderate-to-advanced multilevel IDD. However, despite these regenerative effects, no significant clinical advantages over the sham procedure were observed within 6 months of follow-up.

Indexed as

clinical trialintervertebral disc degenerationintervertebral disc regenerationlow back painRCTregenerative medicinestem cells

Identifiers

PMID40462867
PMCPMC12129703

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.