Evidence map›Paper›PMID 41024309›Full record

ArticleStem cell research & therapy2025

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).

Alireza Beheshti Maal, Ramin Kordi, Hoda Madani, Masoud Khadivi, Navid Moghadam, Ali Asnaashari, Majid Najafi, Mohamadreza Baghaban Eslaminejad, Shayan Farzanbakhsh, Hamidreza Hghighatkhah and 6 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Stem cell research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Article
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

16 authors.

Alireza Beheshti Maal *Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Ramin KordiSports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. ramin_kordi@tums.ac.ir.ORCID http://orcid.org/0000-0002-0116-3018
Hoda Madani *Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Masoud KhadiviSpine Center of Excellence, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Navid MoghadamSports Medicine Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
Ali AsnaashariMehregan Pain Clinic, Tehran, Iran.
Majid NajafiMehregan Pain Clinic, Tehran, Iran.
Mohamadreza Baghaban EslaminejadDepartment of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Shayan FarzanbakhshDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Hamidreza HghighatkhahDepartment of Diagnostic Imaging, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Bahareh SadriDepartment 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.
Ensiyeh Hajizadeh-SaffarDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Nafiseh HassaniDepartment of Stem Cells and Developmental Biology, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Hossein BaharvandDepartment of Stem Cells and Developmental Biology, 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. masvos@royaninstitute.org.ORCID http://orcid.org/0000-0001-5924-4366

Funding

Royesh Venture Capital Royesh Venture Capital
6 · The paper itself

Abstract

aimsThis is a phase I trial, assessing the feasibility, safety, and potential efficacy of intradiscal injection of allogeneic bone marrow-derived clonal mesenchymal stromal cells (BM-cMSCs) in patients suffering from discogenic low back pain (DLBP).

methodsFive patients underwent single intradiscal injection of 9 × 10

resultsNo SAE was observed. Transient injection site pain was the most common AE which resolved within 4-8 days after injection. VAS decreased significantly in three patients, with pain relief sustained through 24 weeks. ODI indicated functional improvement in three patients, with two achieving minimal disability. SF-36 quality of life questionnaire outcomes demonstrated improvements in physical functioning and pain domains in three patients. MRI findings showed modest increases in disc height and apparent diffusion coefficient (ADC) improvements in 2 patients.

conclusionsIntradiscal injection of allogeneic BM-cMSCs appears to be safe and feasible as a potential therapy for DLBP, with promising efficacy in reducing pain and improving function and quality of life. Further studies with larger cohorts and extended follow-ups are needed to confirm these findings and explore long-term structural benefits.

trial registrationIRCT, IRCT20080728001031N30. Registered 21 October 2021, https://irct.behdasht.gov.ir/trial/58723 .

Indexed as

Low Back PainMesenchymal Stem CellsMesenchymal Stem Cell TransplantationAdultFeasibility StudiesFemaleHumansMaleMiddle AgedQuality of LifeTransplantation, HomologousCell-based therapy, intradiscal injectionDiscogenic low back painMesenchymal stromal cellsRegenerative medicine

Identifiers

PMID41024309
PMCPMC12482575

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.