Evidence map›Paper›PMID 38413930›Full record

Trial reportBMC medicine2024

Mesenchymal stromal cells plus basiliximab improve the response of steroid-refractory acute graft-versus-host disease as a second-line therapy: a multicentre, randomized, controlled trial.

Haixia Fu, Xueyan Sun, Ren Lin, Yu Wang, Li Xuan, Han Yao, Yuanyuan Zhang, Xiaodong Mo, Meng Lv, Fengmei Zheng and 15 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04738981 (Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
10.1field-weighted citation impact, top 1% of its field
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.

NCT04738981 phase3completednot on this map

Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial

TypeinterventionalSponsorPeking University People's HospitalRan2021 to 2023Enrolled130ConditionsGraft Vs Host DiseaseArmsUC-MSC, Anti-CD25 mAb
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

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  6. [Research advances in mesenchymal stem cell therapy for graft-versus-host disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026
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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

25 authors at 6 institutions in 1 country.

Haixia Fu *Peking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Xueyan Sun *Peking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Ren Lin *Medical Center of Haematology, State Key Laboratory of Trauma, Burn and Combined Injury, Xinqiao Hospital, Army Medical University, Chongqing, 400037, China.
Yu Wang *Peking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Li Xuan *Medical Center of Haematology, State Key Laboratory of Trauma, Burn and Combined Injury, Xinqiao Hospital, Army Medical University, Chongqing, 400037, China.
Han Yao *Department of Haematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Yuanyuan ZhangPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Xiaodong MoPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Meng LvPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Fengmei ZhengPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Jun KongPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Fengrong WangPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Chenhua YanPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Tingting HanPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Huan ChenPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Yao ChenPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Feifei TangPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Yuqian SunPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Yuhong ChenPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Lanping XuPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Kaiyan LiuPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China.
Xi ZhangMedical Center of Haematology, State Key Laboratory of Trauma, Burn and Combined Injury, Xinqiao Hospital, Army Medical University, Chongqing, 400037, China. zhangxxi@sina.com.
Qifa LiuDepartment of Haematology, Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China. liuqifa628@163.com.
Xiaojun HuangPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China. xjhrm@medmail.com.cn.
Xiaohui ZhangPeking University People's Hospital, Peking University Institute of Haematology, No. 11 Xizhimen South Street, Beijing, 100044, China. zhangxh@bjmu.edu.cn.
Peking University · CNNational Clinical Research Center for Digestive Diseases · CNPeking University People's Hospital · CNSouthern Medical University · CNArmy Medical University · CNXinqiao Hospital · CN

Funding

Beijing Natural Science Foundation 7232188Key Program of National Natural Science Foundation of China 81730004National Key Research and Development Program of China 2017YFA0105503National Natural Science Foundation of China 81800116National Natural Science Foundation of China 81970113
6 · The paper itself

Abstract

backgroundFor patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD), effective second-line regimens are urgently needed. Mesenchymal stromal cells (MSCs) have been used as salvage regimens for SR-aGVHD in the past. However, clinical trials and an overall understanding of the molecular mechanisms of MSCs combined with basiliximab for SR-aGVHD are limited, especially in haploidentical haemopoietic stem cell transplantation (HID HSCT).

methodsThe primary endpoint of this multicentre, randomized, controlled trial was the 4-week complete response (CR) rate of SR-aGVHD. A total of 130 patients with SR-aGVHD were assigned in a 1:1 randomization schedule to the MSC group (receiving basiliximab plus MSCs) or control group (receiving basiliximab alone) (NCT04738981).

resultsMost enrolled patients (96.2%) received HID HSCT. The 4-week CR rate of SR-aGVHD in the MSC group was obviously better than that in the control group (83.1% vs. 55.4%, P = 0.001). However, for the overall response rates at week 4, the two groups were comparable. More patients in the control group used ≥ 6 doses of basiliximab (4.6% vs. 20%, P = 0.008). We collected blood samples from 19 consecutive patients and evaluated MSC-derived immunosuppressive cytokines, including HO1, GAL1, GAL9, TNFIA6, PGE2, PDL1, TGF-β and HGF. Compared to the levels before MSC infusion, the HO1 (P = 0.0072) and TGF-β (P = 0.0243) levels increased significantly 1 day after MSC infusion. At 7 days after MSC infusion, the levels of HO1, GAL1, TNFIA6 and TGF-β tended to increase; however, the differences were not statistically significant. Although the 52-week cumulative incidence of cGVHD in the MSC group was comparable to that in the control group, fewer patients in the MSC group developed cGVHD involving ≥3 organs (14.3% vs. 43.6%, P = 0.006). MSCs were well tolerated, no infusion-related adverse events (AEs) occurred and other AEs were also comparable between the two groups. However, patients with malignant haematological diseases in the MSC group had a higher 52-week disease-free survival rate than those in the control group (84.8% vs. 65.9%, P = 0.031).

conclusionsFor SR-aGVHD after allo-HSCT, especially HID HSCT, the combination of MSCs and basiliximab as the second-line therapy led to significantly better 4-week CR rates than basiliximab alone. The addition of MSCs not only did not increase toxicity but also provided a survival benefit.

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationMesenchymal Stem CellsMesenchymal Stem Cell TransplantationAcute DiseaseBasiliximabHumansSteroidsTransforming Growth Factor betaBasiliximabSteroidsTransforming Growth Factor betaAcute graft-versus-host diseaseHaemopoietic stem cell transplantationHaploidenticalMesenchymal stromal cellsSecond-line therapySteroid-refractory

Identifiers

PMID38413930
PMCPMC10900595
OpenAlexW4392190510

What Socratic holds

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LicenceCC BY
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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 Socratic graph.