Trial reportAnnals of the rheumatic diseases2024
Allogenic bone marrow-derived mesenchymal stromal cell-based therapy for patients with chronic low back pain: a prospective, multicentre, randomised placebo controlled trial (RESPINE study).
Trial report in Annals of the rheumatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03737461 (A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled 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.
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.
A Phase 2/3 Prospective, Multicentre Randomized, Double-blind Trial, Comparing Intra-discal Allogeneic Adult BM-MSC Therapy and Sham-treated Controls in Subjects With Chronic LBP Due to Lumbar DDD Unresponsive to Conventional Therapy
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Platelet-Rich Plasma vs. Mesenchymal Stem Cells for Lumbar Disc Degeneration: A Systematic Review and Meta-Analysis.International journal of molecular sciences · 2026Pooled it
- Clinical efficacy and safety of somatic cell therapy for chronic low back pain: evidence from the pooled randomized controlled trials.Stem cell research & therapy · 2025Pooled it
- Microfragmented Adipose Tissue in Pain Management: Bridging Regenerative Biology and Clinical Therapeutics.Pain and therapy · 2026Review
- Article
- Multidisciplinary expert consensus on clinical diagnosis and therapies for low back pain.Bone research · 2026Article
- Evolving Landscape of Regenerative Therapies: Cell-Based and Cell-Free Approaches for Chronic Low Back Pain.Journal of clinical medicine · 2026Review
- The notochord: development, disease and stem cell-based modelling.Development (Cambridge, England) · 2026Review
- Intradiscal mesenchymal stem cell therapy for degenerative disc disease: a systematic review and meta-analysis of randomized trials.Asian spine journal · 2026Review
- Lumbar Disc Herniation: What's New in Surgical Treatment.Revista brasileira de ortopedia · 2026Article
- [Lumbar Disc Herniation: What's New in Surgical Treatment].Revista brasileira de ortopedia · 2026Article
- Stem cell therapy for degenerative disc disease: A systematic review of preclinical evidence, clinical translation, and future directions.North American Spine Society journal · 2026Review
- Intervertebral disc degeneration.Nature reviews. Disease primers · 2026Review
- Intradermal Application of Allogenic Wharton's Jelly Mesenchymal Stem Cells for Chronic Post-Thoracotomy Wound in an Elderly Patient After Coronary Artery Bypass Grafting: Clinical Case with Brief Literature Review.Diseases (Basel, Switzerland) · 2026Article
- Cell-based therapies for intervertebral disc degeneration: Navigating the path from promise to clinical reality.Journal of orthopaedic translation · 2026Review
- Degenerative Disease of Intervertebral Disc: A Narrative Review of Pathogenesis, Clinical Implications and Therapies.Bioengineering (Basel, Switzerland) · 2025Review
- Mesenchymal Stromal Cells for the Treatment of Discogenic Low Back Pain: A Systematic Review of Clinical Studies.Neurospine · 2025Article
- Efficacy and safety of intrathecal human umbilical cord-derived mesenchymal stromal cell therapy for bone cancer pain: a preclinical study.Stem cell research & therapy · 2025Article
- Recent advances in CAR-MSCs: the new engine of cellular immunotherapy evolution.Journal of hematology & oncology · 2025Review
- Safety of autologous nucleus pulposus cell transplantation with fibrin glue following endoscopic discectomy in chronic low back pain: a preliminary phase I trial.BMC musculoskeletal disorders · 2025Article
- Intradiscal injection of allogeneic bone marrow derived clonal mesenchymal stromal cells in discogenic low back pain: a phase I study on safety and feasibility (RELIEF: phase I).Stem cell research & therapy · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
32 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the efficacy of a single intradiscal injection of allogeneic bone marrow mesenchymal stromal cells (BM-MSCs) versus a sham placebo in patients with chronic low back pain (LBP).
methodsParticipants were randomised in a prospective, double-blind, controlled study to receive either sham injection or intradiscal injection of 20 million allogeneic BM-MSC, between April 2018 and December 2022. The first co-primary endpoint was the rate of responders defined by improvement of the Visual Analogue Scale (VAS) for pain of at least 20% and 20 mm, or improvement of the Oswestry Disability Index (ODI) of 20% between baseline and month 12. The secondary structural co-primary endpoint was assessed by the disc fluid content measured by quantitative MRI T2, between baseline and month 12. Secondary endpoints included pain VAS, ODI, the Short Form (SF)-36 and the minimal clinically important difference in all timepoints (1, 3, 6, 12 and 24 months). We determined the immune response associated with allogeneic cell injection between baseline and 6 months. Serious adverse events (SAEs) were recorded.
results114 patients were randomised (n=58, BM-MSC group; n=56, sham placebo group). At 12 months, the primary outcome was not reached (74% in the BM-MSC group vs 69% in the placebo group; p=0.77). The groups did not differ in all secondary outcomes. No SAE related to the intervention occurred.
conclusionsWhile our study did not conclusively demonstrate the efficacy of allogeneic BM-MSCs for LBP, the procedure was safe. Long-term outcomes of MSC therapy for LBP are still being studied. TRIAL REGISTRATION NUMBER: EudraCT 2017-002092-25/ClinicalTrials.gov: NCT03737461.
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Registered trials
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.