Evidence map›Paper›PMID 30172703›Full record

Trial reportEBioMedicine2018

Purified CD34

Zhihui Dong, Tianyue Pan, Yuan Fang, Zheng Wei, Shiyang Gu, Gang Fang, Yifan Liu, Yang Luo, Hao Liu, Tiejun Zhang and 11 more

Registry-linked trialAbstract readComparative StudyEquivalence TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in EBioMedicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04255004 (Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients With No-option Critical Limb Ischemia), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
–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.

NCT04255004 nacompletednot on this map

Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients With No-option Critical Limb Ischemia

TypeinterventionalSponsorOspedale San DonatoRan2014 to 2019Enrolled76ConditionsCritical Limb Ischemia, Diabetic FootArmsPall Celeris System, point of care device for human cell therapy
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

21 authors.

Zhihui DongDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China. Electronic address: dong.zhihui@zs-hospital.sh.cn.
Tianyue PanDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Yuan FangDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Zheng WeiDepartment of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.
Shiyang GuDepartment of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.
Gang FangDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Yifan LiuDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Yang LuoDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Hao LiuDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Tiejun ZhangDepartment of Epidemiology, School of Public Health, Fudan University, Shanghai, China.
Meiyu HuCore Lab of Zhongshan Hospital, Fudan University, Shanghai, China.
Daqiao GuoDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Xin XuDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Bin ChenDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Junhao JiangDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Jue YangDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Zhenyu ShiDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Ting ZhuDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Yun ShiDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China.
Peng LiuDepartment of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.
Weiguo FuDepartment of Vascular Surgery, Zhongshan Hospital, and Institute of Vascular Surgery, Fudan University, Shanghai, China. Electronic address: fu.weiguo@zs-hospital.sh.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeripheral blood mononuclear cells (PBMNCs) and purified CD34

methodsA randomised single-blinded non-inferiority trial (Number: NCT 02089828) was performed. NO-CLI patients were 1:1 randomised to the PBMNCs and PCCs groups, and compared in relation to safety and efficacy outcomes. The primary efficacy outcomes included major amputation and total amputation over 12 months. The major amputation-free survival (MAFS) and total amputation-free survival (TAFS) rates were calculated.

findingsFifty patients (25 per group, 47 with thromboangiitis obliterans and 3 with other angiitis) were enrolled, with a median follow-up period of 24.5 months (interquartile range: 17-34 months). One patient in the PCCs group was lost at 2 months and one major amputation occurred in the PBMNCs group at 3 months post-transplantation. The total amputation rates at 6 months post-transplantation were 28.0% in the PCCs group and 16.0% in the PBMNCs group (p = 0.343), and remained unchanged at 12 months. The groups did not differ regarding the MAFS and TAFS (Breslow-Wilcoxon test: p = 0.3014 and p = 0.3414). The PCCs group had a significantly higher probability of rest pain relief than the PBMNCs group (Breslow-Wilcoxon test: p = 0.0454).

interpretationPCCs was not inferior to PBMNCs at limb salvage in the treatment of angiitis-induced NO-CLI and appeared to induce earlier ischaemia relief. Each cell type had specific advantages. These outcomes require verification from longer-term trials involving larger numbers of patients. FUND: Training program for outstanding academic leaders of Shanghai health and family planning system (Hundred Talent Program，Grant No. 2018BR40); China National Natural Science Funds (Grant No. 30801122); The excellent core member training programme at Zhongshan Hospital, Fudan University, China (Grant No. 2015ZSYXGG02); and Zhongshan Funds for the Institute of Vascular Surgery, Fudan University, China. CLINICAL

trial registrationThis study is registered with ClinicalTrials.gov (NCT 02089828).

Indexed as

AdultAmputation, SurgicalAnimalsAntigens, CD34Disease Models, AnimalExtremitiesFemaleHumansIschemiaKaplan-Meier EstimateLeukocytes, MononuclearMaleMice, SCIDNeovascularization, PhysiologicPainProspective StudiesAntigens, CD34Cell therapyCritical limb ischaemiaLimb salvagePeripheral blood mononuclear cellsPurified CD34(+) cells

Identifiers

PMID30172703
PMCPMC6156701

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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 OpenQuestion graph.