Evidence map›Paper›PMID 37138332›Full record

ArticleTrials2023

Efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSC PLEB001) for the treatment of grade II-IV steroid-refractory acute graft-versus-host disease: a study protocol for a multicenter, randomized, double-blind, placebo-controlled, phase II trial.

Donglin Yang, Xiaoqiang Hou, Kun Qian, Yuhang Li, Liangding Hu, Liang Li, Mingzhe Han, Chen Yao, Daihong Liu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.6field-weighted citation impact, top 10% 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.

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

6 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
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

9 authors at 4 institutions in 1 country.

Donglin Yang *State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Xiaoqiang Hou *Platinumlife Biotechnology (Beijing) Co., Ltd., Beijing, China.
Kun Qian *School of Medicine, Nankai University, Tianjin, China.
Yuhang LiDepartment of Hematology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Liangding HuDepartment of Hematology, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Liang LiPlatinumlife Biotechnology (Beijing) Co., Ltd., Beijing, China.
Mingzhe HanState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.
Chen YaoPeking University Clinical Research Institute, Peking University First Hospital, Beijing, China. yaochen@hsc.pku.edu.cn.
Daihong LiuSchool of Medicine, Nankai University, Tianjin, China. daihongrm@163.com.ORCID http://orcid.org/0000-0003-3334-9113
Chinese Academy of Medical Sciences & Peking Union Medical College · CNChinese PLA General Hospital · CNNankai University · CNPeking University · CN

Funding

National Natural Science Foundation of China 82070178
6 · The paper itself

Abstract

backgroundSystemic corticosteroid therapy failure is quite common in patients with newly diagnosed acute graft-versus-host disease (aGVHD). Growing evidence has suggested that mesenchymal stem cell (MSC) therapy could be a promising treatment option for aGVHD due to its distinctive immunomodulating functions. However, there is a lack of randomized well-controlled clinical trials.

methodsThis is a clinical trial protocol for a multicenter, randomized, double-blind, placebo-controlled phase II study. The aim of the trial is to evaluate the efficacy and safety of the administration of the human umbilical cord-derived MSC product hUC-MSC PLEB001 in patients with grade II-IV, steroid-refractory aGVHD. A total of 96 patients will be randomized 1:1 to receive MSC or placebo treatment twice per week for 4 weeks, in addition to second-line therapy according to institutional standards. Patients who achieve partial response (PR) at day 28 will be eligible to receive further infusions twice per week for an additional 4 weeks. DISCUSSION: This study will evaluate the efficacy and safety of MSC therapy in patients who have failed first-line steroid treatment for grade II-IV aGVHD.

trial registrationChinese Clinical Trial Registry (ChiCTR), ChiCTR2000035740. Registered on 16 August 2020.

Indexed as

Graft vs Host DiseaseMesenchymal Stem CellsMesenchymal Stem Cell TransplantationAcute DiseaseClinical Trials, Phase II as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSteroidsUmbilical CordSteroidsAcute graft-versus-host diseaseHuman umbilical cordMesenchymal stem cellProtocolSecond-line therapySteroid

Identifiers

PMID37138332
PMCPMC10155385
OpenAlexW4368357359

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.