Evidence map›Paper›PMID 41250139›Full record

Trial reportStem cell research & therapy2025

Mesenchymal stem cells combined with IFN-γ treatment versus mesenchymal stem cells monotherapy: safety and efficacy over five years extension follow-up.

Yi Yang, Xiao He, Mengwei Yao, Zhan Li, Wei Xing, Song Guo Zheng, Xiang Xu

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

7 authors.

Yi Yang *Department of Rheumatology and Immunology, Center for Immune Ageing and Rejuvenation, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.
Xiao He *Department of Rheumatology and Immunology, Center for Immune Ageing and Rejuvenation, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.
Mengwei YaoState Key Laboratory of Trauma and Chemical Poisoning, Department of Stem Cell and Regenerative Medicine, Daping Hospital, Army Medical University, Chongqing, 400042, China.
Zhan LiState Key Laboratory of Trauma and Chemical Poisoning, Department of Stem Cell and Regenerative Medicine, Daping Hospital, Army Medical University, Chongqing, 400042, China.
Wei XingState Key Laboratory of Trauma and Chemical Poisoning, Department of Stem Cell and Regenerative Medicine, Daping Hospital, Army Medical University, Chongqing, 400042, China.
Song Guo ZhengDepartment of Immunology, The School of Cell and Gene Therapy, Songjiang Research Institute and Song Jiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 201600, China. Song.Zheng@shsmu.edu.cn.
Xiang XuYunan Key Laboratory of Stem Cell and Regenerative Medicine, School of Rehabilitation, Kunming Medical University, Kunming, 650500, China. xiangxu@tmmu.edu.cn.ORCID http://orcid.org/0000-0002-1026-2210

Funding

Major scientific and Technological Projects of Yunnan Province 202502AA310012National Natural Science Foundation of China 32100643National Natural Science Foundation of China 82372529Science Foundation of State Key laboratory of Trauma and Chemical Poisoning 2024K003
6 · The paper itself

Abstract

backgroundTo report long-term safety and efficacy of mesenchymal stem cells (MSCs) in combination with and without IFN-γ in patients with rheumatoid arthritis (RA), using pooled data from two randomised clinical trials followed by long-term extension (LTE) study.

methodsCumulative data from two phase 1/2 core trials and their LTE studies were analysed. Safety variables assessed included treatment-emergent adverse events (AEs), serious AEs (SAEs) and laboratory results. Efficacy assessments included ACR20/50/70 responses, Disease Activity Score 28 < 2.6 (remission) and ≤ 3.2 (LDA, low disease activity).

resultsA total of 110 patients received MSCs monotherapy and MSCs combined with IFN-γ treatment. Event rates per 100 patient-years in MSCs monotherapy group and MSCs combined with IFN-γ treatment group, respectively, were 2.47 and 2.31 for SAEs. No increase in the rate of any AE was observed over five years. Clinical response rates remained stable during the LTE study. Initial improvements in LDA/remission observed at year one were sustained over five years of follow-up in both groups, while the MSCs combined with IFN-γ treatment group had higher ACR20 and LDA rates than the MSCs monotherapy group at both one year (100% versus 50.7%, p < 0.001; 39.3% versus 8.7%, p < 0.001) and five years (89.3% versus 44.9%, p < 0.001; 42.9% versus 8.7%, p < 0.001).

conclusionThe long-term safety and efficacy of MSCs with/without IFN-γ combination therapy remained stable. The efficacy of MSCs was maintained through at least five years. These findings support MSCs as a treatment option for patients with active RA.

trial registrationChiCTR-ONC-16,008,770 (2016-07-03) and ChiCTR-INR-17,012,462 (2017-08-24).

Indexed as

Arthritis, RheumatoidInterferon-gammaMesenchymal Stem CellsMesenchymal Stem Cell TransplantationAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedTreatment OutcomeInterferon-gammaInterferon gammaLong-term extension studyMesenchymal stem cellRheumatoid arthritis

Identifiers

PMID41250139
PMCPMC12624986

What Socratic 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 Socratic graph.