Evidence map›Paper›PMID 25995748›Full record

ArticleArchives of medical science : AMS2015

Combined autologous bone marrow mononuclear cell and gene therapy as the last resort for patients with critical limb ischemia.

Jan Skóra, Artur Pupka, Dariusz Janczak, Piotr Barć, Tomasz Dawiskiba, Krzysztof Korta, Dagmara Baczyńska, Agnieszka Mastalerz-Migas, Jerzy Garcarek

Open access · goldAbstract read
In one paragraph

Article in Archives of medical science : AMS, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 4 pooled it
2.3field-weighted citation impact, top 12% 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

15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  4. Growth factors for angiogenesis in peripheral arterial disease.The Cochrane database of systematic reviews · 2017
    Pooled it
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  8. Article
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  10. Cell therapy for peripheral artery disease.Current opinion in pharmacology · 2018
    Review
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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

9 authors at 1 institution in 1 country.

Jan SkóraDepartment of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wroclaw, Poland.
Artur PupkaDepartment of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wroclaw, Poland.
Dariusz JanczakDepartment of Clinical Procedures, Wroclaw Medical University, Wroclaw, Poland.
Piotr BarćDepartment of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wroclaw, Poland.
Tomasz DawiskibaDepartment of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wroclaw, Poland.
Krzysztof KortaDepartment of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wroclaw, Poland.
Dagmara BaczyńskaDepartment of Forensic Medicine, Molecular Techniques Unit, Wroclaw Medical University, Wroclaw, Poland.
Agnieszka Mastalerz-MigasDepartment of Family Medicine, Wroclaw Medical University, Wroclaw, Poland.
Jerzy GarcarekDepartment of General Radiology, Interventional Radiology and Neuroradiology, Wroclaw Medical University, Wroclaw, Poland.
Wroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOur study was designed to investigate the safety and efficacy of combined autologous bone marrow mononuclear cell (MNC) and gene therapy in comparison to conventional drug therapy in patients with critical limb ischemia (CLI). MATERIAL AND

methodsThirty-two patients with CLI persisting for 12-48 months (average time 27.5 months) were randomized into 2 groups, each group consisting of 16 patients. In the first group, administration of autologous bone marrow MNC and vascular endothelial growth factor (VEGF) plasmid was performed. The patients from the second group were treated pharmacologically with pentoxifylline. Ankle-brachial index (ABI) was measured and angiography was performed before and finally 3 months after treatment. The pain was evaluated using the Visual Analog Scale (VAS) before and after 3 months.

resultsAnkle-brachial index improved significantly from 0.29 ±0.21 to 0.52 ±0.23 (p < 0.001) in 12 patients (75.0%) 3 months after the experimental therapy in group 1. In this group angiography showed the development of collateral vessels. Ischemic ulcers healed completely in 11 patients (68.75%). In group 2 the ABI did not improve in any patient; moreover the complete healing of skin ulcers was not found in any of the patients of this group. Amputation was performed in 4 (25.0%) patients in group 1, and in 8 patients (50%) from group 2.

conclusionsThese data after 3-month follow-up indicate that intramuscular injection of MNC combined with gene therapy in patients with chronic CLI is safe, and a more feasible and effective method of treatment than the conventional therapy. However, both therapies are limited by the degree of microcirculation damage.

Indexed as

atherosclerosis obliteranscritical limb ischemiagene therapymarrow stem cells

Identifiers

PMID25995748
PMCPMC4424239
OpenAlexW2020384200

What OpenQuestion holds

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Registered trials

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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.