Evidence map›Paper›PMID 35313967›Full record

Trial reportStem cell research & therapy2022

The peripheral blood mononuclear cells versus purified CD34

Hao Liu, Tianyue Pan, Yifan Liu, Yuan Fang, Gang Fang, Xiaolang Jiang, Bin Chen, Zheng Wei, Shiyang Gu, Peng Liu and 2 more

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

Trial report in Stem cell research & therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02089828 (Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 46% 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.

NCT02089828 naunknown statusnot on this map

Randomized Control Trial on Purified CD34+ Cells Versus Peripheral Blood Mononuclear Cells in Treatment of Critical Limb Ischemia

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2014 to 2018Enrolled50ConditionsThromboangiitis Obliterans, Arteritis, Peripheral Arterial DiseaseArmsautologous purified CD34+ cells, autologous peripheral blood mononuclear cells
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. 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

12 authors at 2 institutions in 2 countries.

Hao Liu *Departments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Tianyue Pan *Departments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Yifan Liu *Departments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Yuan FangDepartments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Gang FangDepartments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Xiaolang JiangDepartments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Bin ChenDepartments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
Zheng WeiDepartments of Hematology of Zhongshan Hospital, Fudan University, Shanghai, China.
Shiyang GuDepartments of Hematology of Zhongshan Hospital, Fudan University, Shanghai, China.
Peng LiuDepartments of Hematology of Zhongshan Hospital, Fudan University, Shanghai, China.
Weiguo FuDepartments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China. fu.weiguo@zs-hospital.sh.cn.
Zhihui DongDepartments of Vascular Surgery of Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China. dzh926@126.com.ORCID 0000-0002-3754-2458
Fudan University · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundsPatients with AICLI constitute a considerable proportion of NO-CLI patients and cannot be treated with surgical or endovascular treatment. Although cell therapy has shown satisfactory results in treating AICLI, research comparing the efficacy of treatment with the 2 kinds of cell products is rare. The aim of this study was to report the 5-year outcomes of a randomized single-blinded noninferiority trial (Number: NCT02089828) on peripheral blood mononuclear cells (PBMNCs) and purified CD34

methodsA randomized single-blinded non-inferiority trial (Number: NCT02089828) was performed. Fifty patients were randomized 1:1 to the PBMNCs and PCCs groups. Efficacy outcomes, safety outcomes and patients' work conditions were analyzed. The primary efficacy outcomes included major amputation and total amputation over 60 months.

resultsDuring the 60-month follow-up, 1 patient was lost to follow-up, 1 died, and 2 underwent major amputation. The major amputation-free survival rate (MAFS) was 92.0% (95% confidence interval [CI] 82.0%-100.0%) in the PBMNCs group and 91.7% (95% CI 81.3%-100.0%) in the PCCs group (P = 0.980). Compared with the PCCs group, the PBMNCs group had a significantly higher 5-year new lesion-free survival rate (100.0% vs. 83.3% [95% CI 69.7-99.7%], P = 0.039). All patients lost their ability to work before transplantation, and the 5-year cumulative return to work (RTW) rates were 88.0% in the PBMNCs group and 76.0% in the PCCs group (P = 0.085).

conclusionThe long-term follow-up outcomes of this trial not only demonstrated similar efficacy and safety for the 2 types of autoimplants but also showed a satisfactory cumulative RTW rate in AICLI patients who underwent cell transplantation.

trial registrationClinicalTrials.gov, number NCT02089828. Registered 14 March 2014, https://clinicaltrials.gov/ct2/show/record/NCT02089828 .

Indexed as

Leukocytes, MononuclearVasculitisCell TransplantationChronic Limb-Threatening IschemiaHumansIschemiaReturn to WorkTreatment OutcomeCD34+Cell transplantationCritical limb ischemia

Identifiers

PMID35313967
PMCPMC8935813
OpenAlexW4221057128

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.