Evidence map›Paper›PMID 41034889›Full record

ArticleBMC musculoskeletal disorders2025

Safety of autologous nucleus pulposus cell transplantation with fibrin glue following endoscopic discectomy in chronic low back pain: a preliminary phase I trial.

Bahareh Sadri, Narges Labibzadeh, Hoda Madani, Alireza Beheshti Maal, Maryam Niknejadi, Nikoo Hossein-Khannazer, Shayan Farzanbakhsh, Shahedeh Karimi, Mohammad Hassanzadeh, Abolfazl Bagherifard and 2 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Bahareh SadriDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.ORCID http://orcid.org/0000-0002-1375-1052
Narges LabibzadehDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.
Hoda MadaniDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.
Alireza Beheshti MaalDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.
Maryam NiknejadiDepartment of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Nikoo Hossein-KhannazerGastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Shayan FarzanbakhshDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.
Shahedeh KarimiDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.
Mohammad HassanzadehBone and Joint Reconstruction Research Center, Department of Orthopedics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Abolfazl BagherifardBone and Joint Reconstruction Research Center, Department of Orthopedics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Mohsen EmadedinDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran.
Massoud VosoughDepartment of Regenerative Medicine, Cell Science Research Center, Royan institute for stem cell biology and technology, ACECR, Tehran, Iran. massoud.vosough@gmail.com.

Funding

Royan Institute for Stem Cell Biology and Technology RI.94000027
6 · The paper itself

Abstract

backgroundIntradiscal cell transplantation has been proposed as a minimally invasive therapeutic modality in chronic low back pain (CLBP) and may prevent future recurrence after surgical procedures. Since nucleus pulposus (NP) cells with the capability to synthesize appropriate extracellular matrix and withstand the pathological microenvironment of degenerative discs could be more practical in CLBP management.

methodsfive patients with CLBP were enrolled and underwent the intradiscal injection of autologous NP cells after endoscopic therapeutic discectomy. They were followed up for 24 months by the evaluation of clinical measurements and magnetic resonance imaging (MRI).

resultsThe primary outcome, safety assessment, was evaluated by recording any complications of surgery or NP cell transplantation during 24 months follow-up. Neither adverse events (AEs) nor serious adverse events (SAEs) were reported. Visual analogue scale (VAS), Oswestry disability index (ODI), and MRI were assessed as secondary outcomes. Reduction of ODI and VAS scores in all five patients indicated improvement in CLBP. Moreover, a comparison of MRI findings between the baseline and endpoint demonstrated improvement in disc protrusion status, less bulging, and more hydration.

conclusionsAccording to these promising results and MRI findings after two years follow-up, intradiscal injection of NP cells after endoscopic discectomy seems safe and could be considered as an effective therapeutic method in CLBP with no recurrence.

trial registrationIranian registry of clinical trials (IRCT): IRCT20080728001031N35; Registration Date: 08/10/2022.

Indexed as

Cell TransplantationChronic PainDiskectomy, PercutaneousEndoscopyFibrin Tissue AdhesiveLow Back PainNucleus PulposusAdultFemaleFollow-Up StudiesHumansMagnetic Resonance ImagingMaleMiddle AgedPain MeasurementTransplantation, AutologousFibrin Tissue AdhesiveCell therapyChronic low back painDegenerative discopathyIntradiscal injectionNucleus pulposus cellsRegenerative medicine

Identifiers

PMID41034889
PMCPMC12487140

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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.