Evidence map›Paper›PMID 33115517›Full record

Trial reportStem cell research & therapy2020

Autologous peripheral blood-derived stem cells transplantation for treatment of no-option angiitis-induced critical limb ischemia: 10-year management experience.

Gang Fang, Xiaolang Jiang, Yuan Fang, Tianyue Pan, Hao Liu, Bichen Ren, Zheng Wei, Shiyang Gu, Bin Chen, Junhao Jiang and 5 more

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 22% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. 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

15 authors at 2 institutions in 1 country.

Gang FangDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Xiaolang JiangDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Yuan FangDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Tianyue PanDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Hao LiuDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Bichen RenDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Zheng WeiDepartment of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.
Shiyang GuDepartment of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.
Bin ChenDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Junhao JiangDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Yun ShiDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Daqiao GuoDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Peng LiuDepartment of Hematology, Zhongshan Hospital, Fudan University, Shanghai, China.
Weiguo FuDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. fu.weiguo@zs-hospital.sh.cn.
Zhihui DongDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, 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

backgroundPrevious studies have demonstrated that no-option angiitis-induced critical limb ischemia (NO-AICLI) could be significantly improved by transplantation of peripheral blood-derived stem cells (PBDSCs). Additionally, a randomized controlled trial (RCT) recently conducted by us suggested that peripheral blood-derived purified CD34+ cells (PCCs) were not inferior to non-purified peripheral blood mononuclear cells (PBMNCs) at limb salvage in treatment of NO-AICLI. However, most of these clinical trials whether RCT or single-arm studies were characterized with a small sample size and absence of long-term outcomes.

methodsTo analyze long-term clinical outcomes of PBDSCs transplantation for NO-AICLI, we reviewed clinical data of patients with NO-AICLI receiving PBDSCs transplantation at our center during the past decade. Meanwhile, we first compared the long-term safety and efficacy of intramuscular transplantation of PCCs versus PBMNCs in a sizable number of patients with NO-AICLI.

resultsFrom May 2009 to December 2019, a total of 160 patients with NO-AICLI patients were treated by PBDSCs transplantation (82 with PCCs, 78 with PBMNCs) at our center. Baseline characteristics between two groups were similar. Up to June 2020, the mean follow-up period was 46.6 ± 35.3 months. No critical adverse events were observed in either group. There was one death during the follow-up period. A total of eight major amputations occurred. The cumulative major amputation-free survival (MAFS) rate at 5 years after PBDSCs transplantation was 94.4%, without difference between two groups (P = .855). Wound healing, rest pain, pain-free walking time, ankle-brachial index, transcutaneous oxygen pressure, and quality of life (QoL) also significantly improved after PBDSCs transplantation.

conclusionsAutologous PBDSCs intramuscular transplantation could significantly decrease the major amputation rates and improve the QoL in patients with NO-AICLI. Long-term observation of a large sample of patients confirmed that the clinical benefits of PBDSCs transplantation were durable, without difference between the PCCs and PBMNCs groups.

Indexed as

Peripheral Blood Stem CellsVasculitisAmputation, SurgicalBone Marrow TransplantationHumansIschemiaLimb SalvageTransplantation, AutologousTreatment OutcomeCD34+ cellsCritical limb ischemiaLimb salvagePeriphreal blood mononuclear cellsStem cells transplantationThromboangiitis obliterans

Identifiers

PMID33115517
PMCPMC7594448
OpenAlexW3096123622

What OpenQuestion holds

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LicenceCC BY
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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.